CompletedNCT00706433Updated Oct 24, 2011Results posted

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

A Phase 2 interventional study of aminolevulinic acid HCL (ALA) and Vehicle (VEH) in Acne Vulgaris, sponsored by DUSA Pharmaceuticals, Inc.. Completed at 14 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2011-10-24.

Sponsored by DUSA Pharmaceuticals, Inc. (part of Sun Pharmaceutical Industries Limited) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 266
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.

Read the detailed description

This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group light dose ranging study of photodynamic therapy in subjects with moderate to severe facial acne vulgaris.

Subjects will be randomized to one of the following four treatment groups (1:1:1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).

Group 1 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
Group 2 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Group 3 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
Group 4 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)

Each subject may receive up to four treatments at three week (± 2 days) intervals. The power density (dose rate) and the total fluence (light dose) used at each treatment is intended to remain constant throughout each subject's participation. If a subject meets or exceeds the criteria restricting retreatment (CRR) prior to retreatment (Section 5.6), he/she will not receive additional PDT treatment at that visit and will be asked to return for the next scheduled PDT visit 3 weeks later, if applicable.

Post-treatment follow-up visits will be scheduled to occur at 3 and 6 weeks after the subject's final PDT.

Grading of the subject's facial acne will be conducted by a blinded evaluator who will remain blinded with respect to the subject's treatment assignment. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.

Safety will be evaluated by adverse events and local skin responses reported during the study.

Conditions studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 750

Keywords

Photodynamic Therapy

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 266 is above the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

DUSA Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

First submitted before DUSA Pharmaceuticals, Inc. became part of Sun Pharmaceutical Industries Limited.

Browse DUSA Pharmaceuticals, Inc. studies →All Sun Pharmaceutical Industries Limited studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject is male or non-pregnant female 12 years of age or older.
Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin \& Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin \& Hair Care for the entire study.

Exclusion criteria

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment.
Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 266 participants (actual)

Study arms

Active comparator
ALA 1000 seconds
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Drug: aminolevulinic acid HCL (ALA)
Active comparator
ALA 500 seconds
Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
Drug: aminolevulinic acid HCL (ALA)
Placebo comparator
Vehicle 1000 seconds
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
Other: Vehicle (VEH)
Placebo comparator
Vehicle 500 seconds
Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Other: Vehicle (VEH)

Interventions

Drugaminolevulinic acid HCL (ALA)
Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
Also known as: Levulan, Levulan Kerastick
OtherVehicle (VEH)
Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.

What researchers measure

Primary outcomes

Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Time frame: Baseline and 3 weeks after final treatment

Secondary outcomes

Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 6 weeks after final treatment
Subject Satisfaction Score
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Time frame: 6 weeks after final treatment
Change in Inflammatory Lesion Counts Relative to Baseline
change in lesion counts compared to baseline
Time frame: Baseline and 6 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
Time frame: Baesline and 6 weeks after final treatment
Hyperpigmentation 48 Hours After PDT #1
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 48 hours after PDT #1
Hyperpigmentation at Visit 3 (Week 3)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 3 (Week 3)
Hyperpigmentation at Visit 5 (Week 6)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 5 (Week 6)
Hyperpigmentation at Visit 7 (Week 9)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 7 (Week 9)
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 9 (3 weeks after final PDT)
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 10 (6 weeks after final PDT)
Hypopigmentation 48 Hours Post PDT #1
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 48 hours post PDT #1
Hypopigmentation at Visit 3 (Week 3)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 3 (Week 3)
Hypopigmentation at Visit 5 (Week 6)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 5 (Week 6)
Hypopigmentation at Visit 7 (Week 9)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 7 (Week 9)
Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 9 (3 weeks after final PDT)
Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 10 (6 weeks after final PDT)
Erythema at Baseline (Pre-light)
After solution application, prior to light treatment Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline (pre-light)
Erythema at Baseline - Post Light Treatment
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline - post light treatment
Erythema 48 Hours After PDT #1
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 48 hours after PDT #1
Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - pre study drug application)
Erythema at Visit 3 (Week 3 - Pre-light)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - pre-light)
Erythema at Visit 3 (Week 3 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - post light treatment)
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Week 6 - prior to study drug application)
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Weeks 6 - pre-light treatment)
Erythema at Visit 5 (Week 6 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Week 6 - post light treatment)
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - prior to study drug application)
Erythema at Visit 7 (Week 9 - Pre Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - pre light treatment)
Erythema at Visit 7 (Week 9 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - post light treatment)
Erythema 3 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 3 Weeks after Final PDT
Erythema 6 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 6 Weeks after Final PDT
Edema at Baseline - Pre Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Baseline - pre light treatment
Edema at Baseline - Post Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Baseline - Post Light Treatment
Edema 48 Hours After PDT #1
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 48 hours after PDT #1
Edema at Visit 3 (Week 3 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - before study drug application)
Edema at Visit 3 (Week 3 - Before Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - before light treatment)
Edema at Visit 3 (Week 3 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - post light treatment)
Edema at Visit 5 (Week 6 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - before study drug application)
Edema at Visit 5 (Week 6 - Pre Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - pre light treatment)
Edema at Visit 5 (Week 6 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - post light treatment)
Edema at Visit 7 (Week 9 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - before study drug application)
Edema at Visit 7 (Week 9 - Prior to Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - prior to light treatment)
Edema at Visit 7 (Week 9 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - post light treatment)
Edema 3 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 3 weeks after final PDT
Edema 6 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 6 weeks after final PDT
Stinging/Burning at Baseline - Before Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - before light treatment
Stinging/Burning at Baseline - During Light
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - during light
Stinging/Burning at Baseline - Post Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - post light treatment
Stinging/Burning 48 Hours Post PDT #1
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 48 hours post PDT #1
Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - before study drug application)
Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - before light treatment)
Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - during light treatment)
Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - post light treatment)
Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - before study drug application)
Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - prior to light treatment)
Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - during light treatment)
Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - post light treatment)
Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - before study drug application)
Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - prior to light treatment)
Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - during light treatment)
Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - post light treatment)
Stinging/Burning at Visit 9 (3 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 9 (3 Weeks after Final PDT)
Stinging/Burning at Visit 10 (6 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 10 (6 Weeks after Final PDT)
Scaling and Dryness 48 Hours After PDT #1
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: 48 hours after PDT #1
Scaling and Dryness at Visit 3 (Week 3)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 3 (Week 3)
Scaling and Dryness at Visit 5 (Week 6)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 5 (Week 6)
Scaling and Dryness at Visit 7 (Week 9)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 7 (Week 9)
Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 9 (3 Weeks after Final PDT)
Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 10 (6 Weeks after Final PDT)
Oozing/Vesiculation/Crusting 48 Hours After PDT #1
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: 48 hours after PDT #1
Oozing/Vesiculation/Crusting at Visit 3 (Week 3)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 3 (Week 3)
Oozing/Vesiculation/Crusting at Visit 5 (Week 6)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 5 (Week 6)
Oozing/Vesiculation/Crusting at Visit 7 (Week 9)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 7 (Week 9)
Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 9 (3 Weeks after Final PDT)
Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 10 (6 Weeks after Final PDT)

Results

Posted Aug 21, 2009

Participant flow

Recruitment period: 3/7/07 - 3/31/08 Types of location: medical clinics

Participant flow — Overall Study
Milestone	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Started	68	65	67	66
Completed	63	62	57	64
Not completed	5	3	10	2
Withdrew: Lost to follow-up	3	1	6	0
Withdrew: Withdrawal by subject	1	2	3	1
Withdrew: Adverse event	0	0	1	0
Withdrew: Protocol violation	1	0	0	0
Withdrew: New job	0	0	0	1

Outcome measures

PrimaryChange in Inflammatory Lesion Counts Relative to Baseline

Time frame:: Baseline and 3 weeks after final treatment
Reported as:: Median · change in lesion count

Change in Inflammatory Lesion Counts Relative to Baseline
change in lesion count	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Change in Inflammatory Lesion Counts Relative to Baseline	-18.0 ± 26.3	-14.0 ± 26.8	-19.0 ± 22.8	-14.5 ± 24.0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · ANCOVA · p = 0.7680Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.

PrimaryInvestigator Global Assessment of Acne Severity Successes

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.

Time frame:: Baseline and 3 weeks after final treatment
Reported as:: Number · participants

Investigator Global Assessment of Acne Severity Successes
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Success	13	11	15	11
Failure	55	54	52	55

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.7975Stratified by study center.

SecondaryPercent Change in Inflammatory Lesion Counts Relative to Baseline

Time frame:: Baseline and 3 weeks after final treatment
Reported as:: Median · percent change in lesion count

Percent Change in Inflammatory Lesion Counts Relative to Baseline
percent change in lesion count	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Percent Change in Inflammatory Lesion Counts Relative to Baseline	-37.5 ± 38.79	-29.2 ± 46.68	-41.7 ± 38.82	-37.0 ± 40.23

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · ANOVA · p = >0.10Rank transformed data.

SecondaryPercent Change in Inflammatory Lesion Counts Relative to Baseline

Time frame:: Baseline and 6 weeks after final treatment
Reported as:: Median · percent change in lesion count

Percent Change in Inflammatory Lesion Counts Relative to Baseline
percent change in lesion count	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Percent Change in Inflammatory Lesion Counts Relative to Baseline	-34.4 ± 37.8	-29.0 ± 42.57	-48.4 ± 32.81	-45.2 ± 50.15

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · ANOVA · p = >0.10Rank transformed data.

SecondarySubject Satisfaction Score

Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)

Time frame:: 6 weeks after final treatment
Reported as:: Number · participants

Subject Satisfaction Score
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Excellent	23	11	23	26
Good	18	28	20	23
Fair	17	17	11	12
Poor	6	5	4	5

SecondaryChange in Inflammatory Lesion Counts Relative to Baseline

change in lesion counts compared to baseline

Time frame:: Baseline and 6 weeks after final treatment
Reported as:: Median · change in lesion count

Change in Inflammatory Lesion Counts Relative to Baseline
change in lesion count	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Change in Inflammatory Lesion Counts Relative to Baseline	-18.5 ± 30.15	-13.0 ± 28.74	-21.0 ± 23.63	-17.0 ± 26.71

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · ANCOVA · p = 0.1103Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.

SecondaryInvestigator Global Assessment of Acne Severity Successes

Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules

Time frame:: Baesline and 6 weeks after final treatment
Reported as:: Number · participants

Investigator Global Assessment of Acne Severity Successes
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Success	15	11	16	16
Failure	53	54	51	50

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.7228Stratified by study center.

SecondaryHyperpigmentation 48 Hours After PDT #1

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Time frame:: 48 hours after PDT #1
Reported as:: Number · participants

Hyperpigmentation 48 Hours After PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	49	49	49	53
Grade 1 (light)	14	14	10	7
Grade 2 (moderate - small)	4	1	7	3
Grade 3 (moderate - mod)	1	0	0	3
Grade 4 (marked)	0	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3416Stratified by study center.

SecondaryHyperpigmentation at Visit 3 (Week 3)

Time frame:: Visit 3 (Week 3)
Reported as:: Number · participants

Hyperpigmentation at Visit 3 (Week 3)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	49	50	48	52
Grade 1 (light)	10	10	10	8
Grade 2 (moderate - small)	4	2	4	4
Grade 3 (moderate - mod)	1	0	0	2
Grade 4 (marked)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5759Stratified by study center.

SecondaryHyperpigmentation at Visit 5 (Week 6)

Time frame:: Visit 5 (Week 6)
Reported as:: Number · participants

Hyperpigmentation at Visit 5 (Week 6)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	44	51	46	49
Grade 1 (light)	13	9	12	8
Grade 2 (moderate - small)	3	3	2	4
Grade 3 (moderate - mod)	2	0	0	2
Grade 4 (marked)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4754Stratified by study center.

SecondaryHyperpigmentation at Visit 7 (Week 9)

Time frame:: Visit 7 (Week 9)
Reported as:: Number · participant

Hyperpigmentation at Visit 7 (Week 9)
participant	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	49	49	45	52
Grade 1 (light)	9	11	11	10
Grade 2 (moderate - small)	4	2	1	3
Grade 3 (moderate - mod)	1	0	0	0
Grade 4 (marked)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4096Stratified by study center.

SecondaryHyperpigmentation at Visit 9 (3 Weeks After Final PDT)

Time frame:: Visit 9 (3 weeks after final PDT)
Reported as:: Number · participants

Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	45	49	43	51
Grade 1 (light)	12	10	11	7
Grade 2 (moderate - small)	5	2	3	5
Grade 3 (moderate - mod)	0	0	0	0
Grade 4 (marked)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5812Stratified by study center.

SecondaryHyperpigmentation at Visit 10 (6 Weeks After Final PDT)

Time frame:: Visit 10 (6 weeks after final PDT)
Reported as:: Number · participants

Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	48	50	46	50
Grade 1 (light)	12	9	7	10
Grade 2 (moderate - small)	1	2	4	3
Grade 3 (moderate - mod)	2	1	0	1
Grade 4 (marked)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.8679Stratified by study center.

SecondaryHypopigmentation 48 Hours Post PDT #1

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Time frame:: 48 hours post PDT #1
Reported as:: Number · participants

Hypopigmentation 48 Hours Post PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	67	64	65	64
Grade 1 (light)	1	1	0	2
Grade 2 (moderate - small)	0	0	1	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3666Stratified by study center.

SecondaryHypopigmentation at Visit 3 (Week 3)

Time frame:: Visit 3 (Week 3)
Reported as:: Number · participants

Hypopigmentation at Visit 3 (Week 3)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	62	61	65
Grade 1 (light)	2	0	1	1
Grade 2 (moderate - small)	1	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3080Stratified by study center.

SecondaryHypopigmentation at Visit 5 (Week 6)

Time frame:: Visit 5 (Week 6)
Reported as:: Number · participants

Hypopigmentation at Visit 5 (Week 6)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	59	63	60	63
Grade 1 (light)	3	0	0	0
Grade 2 (moderate - small)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryHypopigmentation at Visit 7 (Week 9)

Time frame:: Visit 7 (Week 9)
Reported as:: Number · participants

Hypopigmentation at Visit 7 (Week 9)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	62	57	65
Grade 1 (light)	2	0	0	0
Grade 2 (moderate - small)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryHypopigmentation at Visit 9 (3 Weeks After Final PDT)

Time frame:: Visit 9 (3 weeks after final PDT)
Reported as:: Number · participants

Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	58	61	57	63
Grade 1 (light)	4	0	0	0
Grade 2 (moderate - small)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryHypopigmentation at Visit 10 (6 Weeks After Final PDT)

Time frame:: Visit 10 (6 weeks after final PDT)
Reported as:: Number · participants

Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	62	57	64
Grade 1 (light)	2	0	0	0
Grade 2 (moderate - small)	1	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3916Stratified by study center.

SecondaryErythema at Baseline (Pre-light)

After solution application, prior to light treatment Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame:: Baseline (pre-light)
Reported as:: Number · participants

Erythema at Baseline (Pre-light)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	29	31	35	29
Grade 1 (minimal)	24	20	19	25
Grade 2 (mild)	13	13	12	12
Grade 3 (moderate)	2	1	1	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.8387Stratified by study center.

SecondaryErythema at Baseline - Post Light Treatment

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Time frame:: Baseline - post light treatment
Reported as:: Number · participants

Erythema at Baseline - Post Light Treatment
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	16	18	22	21
Grade 1 (minimal)	23	24	19	27
Grade 2 (mild)	26	16	22	15
Grade 3 (moderate)	3	7	4	3
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.1489Stratified by study center.

SecondaryErythema 48 Hours After PDT #1

Time frame:: 48 hours after PDT #1
Reported as:: Number · participants

Erythema 48 Hours After PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	19	16	34	29
Grade 1 (minimal)	24	21	25	30
Grade 2 (mild)	14	23	6	7
Grade 3 (moderate)	10	3	1	0
Grade 4 (severe)	1	2	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = <0.0001Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4143 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0005 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0003 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = <0.0001 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = <0.0001 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.9700 (Not adjusted for multiple comparisons.)Stratified by study center.

SecondaryErythema at Visit 3 (Week 3 - Pre Study Drug Application)

Time frame:: Visit 3 (Week 3 - pre study drug application)
Reported as:: Number · participants

Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	36	35	34	34
Grade 1 (minimal)	20	16	23	23
Grade 2 (mild)	8	11	5	9
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2544Stratified by study center.

SecondaryErythema at Visit 3 (Week 3 - Pre-light)

Time frame:: Visit 3 (Week 3 - pre-light)
Reported as:: Number · participants

Erythema at Visit 3 (Week 3 - Pre-light)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	27	30	27	32
Grade 1 (minimal)	24	18	27	20
Grade 2 (mild)	11	12	7	12
Grade 3 (moderate)	0	1	1	1
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4321Stratified by study center.

SecondaryErythema at Visit 3 (Week 3 - Post Light Treatment)

Time frame:: Visit 3 (Week 3 - post light treatment)
Reported as:: Number · participants

Erythema at Visit 3 (Week 3 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	13	16	18	21
Grade 1 (minimal)	28	20	30	23
Grade 2 (mild)	17	18	13	19
Grade 3 (moderate)	4	6	1	2
Grade 4 (severe)	0	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0317Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5818 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0395 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.7426 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0029 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2142 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0781 (Not adjusted for multiple comparisons.)Stratified by study center.

SecondaryErythema at Visit 5 (Week 6 - Prior to Study Drug Application)

Time frame:: Visit 5 (Week 6 - prior to study drug application)
Reported as:: Number · participants

Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	36	35	31	34
Grade 1 (minimal)	20	21	22	23
Grade 2 (mild)	6	7	7	6
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.9886Stratified by study center.

SecondaryErythema at Visit 5 (Weeks 6 - Pre-light Treatment)

Time frame:: Visit 5 (Weeks 6 - pre-light treatment)
Reported as:: Number · participants

Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	27	20	22	29
Grade 1 (minimal)	22	28	29	21
Grade 2 (mild)	9	12	9	11
Grade 3 (moderate)	0	1	0	1
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.6907Stratified by study center.

SecondaryErythema at Visit 5 (Week 6 - Post Light Treatment)

Time frame:: Visit 5 (Week 6 - post light treatment)
Reported as:: Number · participants

Erythema at Visit 5 (Week 6 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	18	13	15	19
Grade 1 (minimal)	16	18	28	24
Grade 2 (mild)	19	24	15	17
Grade 3 (moderate)	4	6	2	2
Grade 4 (severe)	1	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0047Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.6116 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0209 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0513 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0019 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0089 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5260 (Not adjusted for multiple comparisons.)Stratified by study center.

SecondaryErythema at Visit 7 (Week 9 - Prior to Study Drug Application)

Time frame:: Visit 7 (Week 9 - prior to study drug application)
Reported as:: Number · participants

Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	37	34	31	36
Grade 1 (minimal)	23	22	22	25
Grade 2 (mild)	3	6	4	4
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.7820Stratified by study center.

SecondaryErythema at Visit 7 (Week 9 - Pre Light Treatment)

Time frame:: Visit 7 (Week 9 - pre light treatment)
Reported as:: Number · participants

Erythema at Visit 7 (Week 9 - Pre Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	28	26	28	33
Grade 1 (minimal)	16	24	16	21
Grade 2 (mild)	11	8	11	7
Grade 3 (moderate)	1	2	1	1
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4965Stratified by study center.

SecondaryErythema at Visit 7 (Week 9 - Post Light Treatment)

Time frame:: Visit 7 (Week 9 - post light treatment)
Reported as:: Number · participant

Erythema at Visit 7 (Week 9 - Post Light Treatment)
participant	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	20	14	20	18
Grade 1 (minimal)	13	18	19	23
Grade 2 (mild)	22	21	15	19
Grade 3 (moderate)	1	7	2	2
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0728Stratified by study center.

SecondaryErythema 3 Weeks After Final PDT

Time frame:: 3 Weeks after Final PDT
Reported as:: Number · participants

Erythema 3 Weeks After Final PDT
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	36	35	32	42
Grade 1 (minimal)	21	18	21	16
Grade 2 (mild)	5	8	4	5
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5480Stratified by study center.

SecondaryErythema 6 Weeks After Final PDT

Time frame:: 6 Weeks after Final PDT
Reported as:: Number · participants

Erythema 6 Weeks After Final PDT
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	39	33	30	43
Grade 1 (minimal)	21	20	22	20
Grade 2 (mild)	3	9	5	1
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0301Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0564 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.4470 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2804 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.1835 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0103 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.1319 (Not adjusted for multiple comparisons.)Stratified by study center.

SecondaryEdema at Baseline - Pre Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Time frame:: Baseline - pre light treatment
Reported as:: Number · participants

Edema at Baseline - Pre Light Treatment
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	65	63	64	65
Grade 1 (minimal)	3	2	3	1
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Baseline - Post Light Treatment

Time frame:: Baseline - Post Light Treatment
Reported as:: Number · participants

Edema at Baseline - Post Light Treatment
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	62	63	64	65
Grade 1 (minimal)	5	2	3	1
Grade 2 (mild)	1	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4378Stratified by study center.

SecondaryEdema 48 Hours After PDT #1

Time frame:: 48 hours after PDT #1
Reported as:: Number · participants

Edema 48 Hours After PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	64	57	61	64
Grade 1 (minimal)	4	7	5	2
Grade 2 (mild)	0	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3430Stratified by study center.

SecondaryEdema at Visit 3 (Week 3 - Before Study Drug Application)

Time frame:: Visit 3 (Week 3 - before study drug application)
Reported as:: Number · participants

Edema at Visit 3 (Week 3 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	62	61	61	66
Grade 1 (minimal)	2	1	1	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 3 (Week 3 - Before Light Treatment)

Time frame:: Visit 3 (Week 3 - before light treatment)
Reported as:: Number · participants

Edema at Visit 3 (Week 3 - Before Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	60	61	65
Grade 1 (minimal)	2	1	1	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 3 (Week 3 - Post Light Treatment)

Time frame:: Visit 3 (Week 3 - post light treatment)
Reported as:: Number · participants

Edema at Visit 3 (Week 3 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	59	61	64
Grade 1 (minimal)	2	2	1	1
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 5 (Week 6 - Before Study Drug Application)

Time frame:: Visit 5 (Week 6 - before study drug application)
Reported as:: Number · participants

Edema at Visit 5 (Week 6 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	63	59	62
Grade 1 (minimal)	2	0	1	1
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 5 (Week 6 - Pre Light Treatment)

Time frame:: Visit 5 (Week 6 - pre light treatment)
Reported as:: Number · participants

Edema at Visit 5 (Week 6 - Pre Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	56	61	59	61
Grade 1 (minimal)	2	0	1	1
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 5 (Week 6 - Post Light Treatment)

Time frame:: Visit 5 (Week 6 - post light treatment)
Reported as:: Number · participants

Edema at Visit 5 (Week 6 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	55	61	57	62
Grade 1 (minimal)	3	0	3	0
Grade 2 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 7 (Week 9 - Before Study Drug Application)

Time frame:: Visit 7 (Week 9 - before study drug application)
Reported as:: Number · participants

Edema at Visit 7 (Week 9 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	62	56	65
Grade 1 (minimal)	3	0	1	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 7 (Week 9 - Prior to Light Treatment)

Time frame:: Visit 7 (Week 9 - prior to light treatment)
Reported as:: Number · participants

Edema at Visit 7 (Week 9 - Prior to Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	53	59	56	62
Grade 1 (minimal)	3	1	0	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema at Visit 7 (Week 9 - Post Light Treatment)

Time frame:: Visit 7 (Week 9 - post light treatment)
Reported as:: Number · participants

Edema at Visit 7 (Week 9 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	53	59	55	61
Grade 1 (minimal)	3	1	1	1
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema 3 Weeks After Final PDT

Time frame:: 3 weeks after final PDT
Reported as:: Number · participants

Edema 3 Weeks After Final PDT
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	62	60	57	63
Grade 1 (minimal)	0	1	0	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryEdema 6 Weeks After Final PDT

Time frame:: 6 weeks after final PDT
Reported as:: Number · participants

Edema 6 Weeks After Final PDT
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	62	62	57	64
Grade 1 (minimal)	1	0	0	0
Grade 2 (mild)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Baseline - Before Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Time frame:: Baseline - before light treatment
Reported as:: Number · participants

Stinging/Burning at Baseline - Before Light Treatment
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	56	52	64	62
Grade 1 (minimal)	7	11	3	4
Grade 2 (moderate)	5	2	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0165Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2252 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0179 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0233 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.1573 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2039 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Baseline - During Light

Time frame:: Baseline - during light
Reported as:: Number · participants

Stinging/Burning at Baseline - During Light
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	43	33	59	58
Grade 1 (minimal)	21	26	6	7
Grade 2 (moderate)	4	6	2	1
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.1594Stratified by study center.

SecondaryStinging/Burning at Baseline - Post Light Treatment

Time frame:: Baseline - post light treatment
Reported as:: Number · participants

Stinging/Burning at Baseline - Post Light Treatment
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	53	47	63	62
Grade 2 (minimal)	14	17	4	4
Grade 3 (moderate)	1	1	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5838Stratified by study center.

SecondaryStinging/Burning 48 Hours Post PDT #1

Time frame:: 48 hours post PDT #1
Reported as:: Number · participants

Stinging/Burning 48 Hours Post PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	52	64	63
Grade 1 (minimal)	6	8	2	3
Grade 2 (moderate)	1	3	0	0
Grade 3 (severe)	0	2	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0064Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0939 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.3173 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2207 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0183 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0254 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)

Time frame:: Visit 3 (Week 3 - before study drug application)
Reported as:: Number · participants

Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	61	60	64
Grade 1 (minimal)	2	1	2	2
Grade 2 (moderate)	1	0	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4753Stratified by study center.

SecondaryStinging/Burning at Visit 3 (Week 3 - Before Light Treatment)

Time frame:: Visit 3 (Week 3 - before light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	53	49	62	61
Grade 1 (minimal)	6	10	0	4
Grade 2 (moderate)	3	2	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.1728Stratified by study center.

SecondaryStinging/Burning at Visit 3 (Week 3 - During Light Treatment)

Time frame:: Visit 3 (Week 3 - during light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	46	33	59	58
Grade 1 (minimal)	9	19	3	7
Grade 2 (moderate)	7	8	0	0
Grade 3 (severe)	0	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0002Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.5313 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0045 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0045 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0012 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0015 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 3 (Week 3 - Post Light Treatment)

Time frame:: Visit 3 (Week 3 - post light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	53	49	60	59
Grade 1 (minimal)	6	9	2	6
Grade 2 (moderate)	3	3	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0892Stratified by study center.

SecondaryStinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)

Time frame:: Visit 5 (Week 6 - before study drug application)
Reported as:: Number · participants

Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	62	60	62
Grade 1 (minimal)	1	1	0	0
Grade 2 (moderate)	0	0	0	1
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4575Stratified by study center.

SecondaryStinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)

Time frame:: Visit 5 (Week 6 - prior to light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	50	49	56	59
Grade 1 (minimal)	7	10	3	2
Grade 2 (moderate)	1	2	1	1
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.8848Stratified by study center.

SecondaryStinging/Burning at Visit 5 (Week 6 - During Light Treatment)

Time frame:: Visit 5 (Week 6 - during light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	41	34	57	59
Grade 1 (minimal)	10	16	2	2
Grade 2 (moderate)	7	11	1	1
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0008Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4091 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0176 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0245 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0020 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0022 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.9372 (Not adjusted for multiple comparisons.)Stratified by study center.

SecondaryStinging/Burning at Visit 5 (Week 6 - Post Light Treatment)

Time frame:: Visit 5 (Week 6 - post light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	47	49	59	60
Grade 1 (minimal)	10	8	0	1
Grade 2 (moderate)	1	4	1	1
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2390Stratified by study center.

SecondaryStinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)

Time frame:: Visit 7 (Week 9 - before study drug application)
Reported as:: Number · participants

Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	63	62	57	63
Grade 1 (minimal)	0	0	0	2
Grade 2 (moderate)	0	0	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)

Time frame:: Visit 7 (Week 9 - prior to light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	48	51	55	62
Grade 1 (minimal)	8	6	1	0
Grade 2 (moderate)	0	3	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0463Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.1261 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0947 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0886 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 7 (Week 9 - During Light Treatment)

Time frame:: Visit 7 (Week 9 - during light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	39	28	54	59
Grade 1 (minimal)	14	21	2	3
Grade 2 (moderate)	3	10	0	0
Grade 3 (severe)	0	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = <0.0001Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0255 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0576 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0686 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0004 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0005 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 7 (Week 9 - Post Light Treatment)

Time frame:: Visit 7 (Week 9 - post light treatment)
Reported as:: Number · participants

Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	49	40	54	61
Grade 1 (minimal)	7	14	2	1
Grade 2 (moderate)	0	6	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0006Stratified by study center.
ALA 1000 Seconds vs ALA 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0245 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 1000 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.
ALA 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.
ALA 500 Seconds vs Vehicle 1000 Seconds · Cochran-Mantel-Haenszel · p = 0.0097 (Not adjusted for multiple comparisons.)Stratified by study center.
ALA 500 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0146 (Not adjusted for multiple comparisons.)Stratified by study center.
Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryStinging/Burning at Visit 9 (3 Weeks After Final PDT)

Time frame:: Visit 9 (3 Weeks after Final PDT)
Reported as:: Number · participants

Stinging/Burning at Visit 9 (3 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	61	57	62
Grade 1 (minimal)	1	0	0	0
Grade 2 (moderate)	0	0	0	0
Grade 3 (severe)	0	0	0	1

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4235Stratified by study center.

SecondaryStinging/Burning at Visit 10 (6 Weeks After Final PDT)

Time frame:: Visit 10 (6 Weeks after Final PDT)
Reported as:: Number · participants

Stinging/Burning at Visit 10 (6 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	63	61	57	63
Grade 1 (minimal)	0	1	0	1
Grade 2 (moderate)	0	0	0	0
Grade 3 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryScaling and Dryness 48 Hours After PDT #1

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Time frame:: 48 hours after PDT #1
Reported as:: Number · participants

Scaling and Dryness 48 Hours After PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	38	35	47	49
Grade 1 (minimal)	20	20	14	14
Grade 2 (mild)	6	6	3	2
Grade 3 (moderate)	4	3	1	1
Grade 4 (severe)	0	1	1	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0865Stratified by study center.

SecondaryScaling and Dryness at Visit 3 (Week 3)

Time frame:: Visit 3 (Week 3)
Reported as:: Number · participants

Scaling and Dryness at Visit 3 (Week 3)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	52	48	44	55
Grade 1 (minimal)	11	11	14	8
Grade 2 (mild)	1	2	4	3
Grade 3 (moderate)	0	1	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.6230Stratified by study center.

SecondaryScaling and Dryness at Visit 5 (Week 6)

Time frame:: Visit 5 (Week 6)
Reported as:: Number · participants

Scaling and Dryness at Visit 5 (Week 6)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	52	50	40	51
Grade 1 (minimal)	6	13	14	9
Grade 2 (mild)	4	0	4	2
Grade 3 (moderate)	0	0	2	1
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.0963Stratified by study center.

SecondaryScaling and Dryness at Visit 7 (Week 9)

Time frame:: Visit 7 (Week 9)
Reported as:: Number · participants

Scaling and Dryness at Visit 7 (Week 9)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	44	50	41	56
Grade 1 (minimal)	17	10	11	5
Grade 2 (mild)	2	2	3	4
Grade 3 (moderate)	0	0	2	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.4814Stratified by study center.

SecondaryScaling and Dryness at Visit 9 (3 Weeks After Final PDT)

Time frame:: Visit 9 (3 Weeks after Final PDT)
Reported as:: Number · participants

Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	52	49	44	51
Grade 1 (minimal)	7	10	10	11
Grade 2 (mild)	3	2	3	1
Grade 3 (moderate)	0	0	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.7153Stratified by study center.

SecondaryScaling and Dryness at Visit 10 (6 Weeks After Final PDT)

Time frame:: Visit 10 (6 Weeks after Final PDT)
Reported as:: Number · participants

Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	46	45	43	56
Grade 1 (minimal)	15	15	10	7
Grade 2 (mild)	2	1	4	1
Grade 3 (moderate)	0	1	0	0
Grade 4 (severe)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3832Stratified by study center.

SecondaryOozing/Vesiculation/Crusting 48 Hours After PDT #1

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Time frame:: 48 hours after PDT #1
Reported as:: Number · participants

Oozing/Vesiculation/Crusting 48 Hours After PDT #1
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	62	62	63	62
Grade 1 (minimal)	3	0	2	4
Grade 2 (mild)	2	2	1	0
Grade 3 (moderate)	1	1	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.2908Stratified by study center.

SecondaryOozing/Vesiculation/Crusting at Visit 3 (Week 3)

Time frame:: Visit 3 (Week 3)
Reported as:: Number · participants

Oozing/Vesiculation/Crusting at Visit 3 (Week 3)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	58	59	59	65
Grade 1 (minimal)	5	3	2	0
Grade 2 (mild)	1	0	1	1
Grade 3 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.8096Stratified by study center.

SecondaryOozing/Vesiculation/Crusting at Visit 5 (Week 6)

Time frame:: Visit 5 (Week 6)
Reported as:: Number · participant

Oozing/Vesiculation/Crusting at Visit 5 (Week 6)
participant	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	59	57	56	61
Grade 1 (minimal)	3	6	3	2
Grade 2 (mild)	0	0	1	0
Grade 3 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3080Stratified by study center.

SecondaryOozing/Vesiculation/Crusting at Visit 7 (Week 9)

Time frame:: Visit 7 (Week 9)
Reported as:: Number · participants

Oozing/Vesiculation/Crusting at Visit 7 (Week 9)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	61	58	53	63
Grade 1 (minimal)	2	4	3	2
Grade 2 (mild)	0	0	1	0
Grade 3 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 0.3208Stratified by study center.

SecondaryOozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)

Time frame:: Visit 9 (3 Weeks after Final PDT)
Reported as:: Number · participants

Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)
participants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	59	59	51	60
Grade 1 (minimal)	3	2	6	3
Grade 2 (mild)	0	0	0	0
Grade 3 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

SecondaryOozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)

Time frame:: Visit 10 (6 Weeks after Final PDT)
Reported as:: Number · particpants

Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)
particpants	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Grade 0 (none)	60	60	55	63
Grade 1 (minimal)	3	2	2	1
Grade 2 (mild)	0	0	0	0
Grade 3 (moderate)	0	0	0	0

Statistical analysis

ALA 1000 Seconds vs ALA 500 Seconds vs Vehicle 1000 Seconds vs Vehicle 500 Seconds · Cochran-Mantel-Haenszel · p = 1.0Stratified by study center.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ALA 1000 Seconds	—	0/68 (0%)	—
ALA 500 Seconds	—	0/65 (0%)	—
Vehicle 1000 Seconds	—	0/67 (0%)	—
Vehicle 500 Seconds	—	0/66 (0%)	—

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds
Itching of faceInjury, poisoning and procedural complications	14/68	20/65	6/67	6/66
Stinging/BurningInjury, poisoning and procedural complications	17/68	17/65	6/67	5/66
ErythemaInjury, poisoning and procedural complications	13/68	5/65	1/67	1/66
NasopharyngitisRespiratory, thoracic and mediastinal disorders	6/68	7/65	4/67	4/66
Dry skinInjury, poisoning and procedural complications	7/68	4/65	3/67	4/66
Tightness of skinInjury, poisoning and procedural complications	4/68	6/65	2/67	1/66
Facial PainInjury, poisoning and procedural complications	4/68	6/65	0/67	0/66
Peeling of skinInjury, poisoning and procedural complications	6/68	5/65	1/67	2/66
Upper respiratory tract infectionInfections and infestations	5/68	2/65	0/67	5/66
HeadacheNervous system disorders	5/68	4/65	3/67	2/66

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
<=18 years	41	44	33	37	155
Between 18 and 65 years	27	21	34	29	111
>=65 years	0	0	0	0	0

Age Continuous
Age Continuous(years)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Mean	20.0 ± 6.15	19.4 ± 6.82	21.3 ± 6.77	19.8 ± 5.31	20.1 ± 6.3

Sex: Female, Male
Sex: Female, Male(Participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Female	30	35	38	35	138
Male	38	30	29	31	128

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Hispanic or Latino	12	7	11	9	39
Not Hispanic or Latino	56	58	56	57	227
Unknown or Not Reported	0	0	0	0	0

Edema
Edema(participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Grade 0 (none)	65	64	65	65	259
Grade 1 (minimal)	3	1	2	1	7

Erythema
Erythema(participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Grade 0 (none)	37	34	41	36	148
Grade 1 (minimal)	24	20	16	21	81
Grade 2 (mild)	6	11	9	8	34
Grade 3 (moderate)	1	0	1	1	3

Fitzpatrick Skin Type
Fitzpatrick Skin Type(participant)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Type I - never tans (sensitive)	0	3	2	3	8
Type II - tans minimally (sensitive)	16	13	14	19	62
Type III - tans gradually (light brown)(normal)	24	24	24	15	87
Type IV - always tans well (moderate brown)	17	15	15	16	63
Type V - tans profusely (dark brown)	7	4	6	10	27
Type VI - deeply pigmented (insensitive)	4	6	6	3	19

Hyperpigmentation
Hyperpigmentation(participants)	ALA 1000 Seconds	ALA 500 Seconds	Vehicle 1000 Seconds	Vehicle 500 Seconds	Total
Grade 0 (none)	50	48	49	53	200
Grade 1 (light)	12	16	12	6	46
Grade 2 (moderate - small)	5	1	6	4	16
Grade 3 (moderate - moderate)	1	0	0	3	4

6 further baseline measures are reported on the registry.

Study locations

14 sites

Burke Pharmaceutical Research
Hot Springs, Arkansas 71913, United States
Therapeutics Clinical Research
San Diego, California 92123, United States
Cherry Creek Research, Inc.
Denver, Colorado 80209, United States
Kenneth R. Beer, M.D. P.A.
West Palm Beach, Florida 33401, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia 30078, United States
Laser and Skin Surger Center of Indiana
Carmel, Indiana 46032, United States
Derm Research PLLC
Louisville, Kentucky 40217, United States
Minnesota Clinical Study Center
Fridley, Minnesota 55432, United States
Downstate Med Ctr
Brooklyn, New York 11203, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033, United States
Tennessee Clinical Research Center
Nashville, Tennessee 37215, United States
Derm Research Inc
Austin, Texas 78759, United States
Baylor Research Institute
Dallas, Texas 75246, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah 84124, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00706433
Lead sponsor: DUSA Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Jun 27, 2008
Start date: Mar 2007
Primary completion: Jul 2008
Completion: Jul 2008
Results posted: Aug 21, 2009
Last update: Oct 24, 2011

Study contacts

Stuart Marcus, M.D., PhD

study director · Sponsor GmbH

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Aminolevulinic Acid

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Acne Vulgaris

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