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CompletedNCT03292640Updated Mar 1, 2021Results posted

A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks

A Phase 3 interventional study of DFD-03 (0.1% tazarotene) Lotion and DFD-03 (0% tazarotene) Lotion (Placebo) in Acne Vulgaris, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-03-01.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
547
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study summary

Enrollment of subjects with mild to moderate facial acne vulgaris.

Co-Primary efficacy endpoints included:

  • Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
  • Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
  • Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
Read the detailed description

Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily with approximately 12 hours between applications. Subjects were instructed to treat the entire face (and chest/back including shoulders, if applicable).

Co-Primary efficacy endpoints included:

  • Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face
  • Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face
  • Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.

The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed at the Baseline Visit.

02

Conditions studied

  • Acne Vulgaris

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03

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject must be at least 9 years of age.
  2. Female subjects must be having their period at the Baseline Visit (as reported by the subject), except for subjects using hormonal contraceptives that preclude menstrual periods, if the subject is premenarcheal, is postmenopausal for at least 12 months prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is without a uterus and /or both ovaries.
  3. A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face have the option of treating their back and/or chest (including shoulders) in addition to their face.
  4. Inflammatory lesion count (papules and pustules) of at least 20 on the face, and non-inflammatory lesion count (closed and open comedones) of at least 25 on the face, including the nose, and no more than 2 nodulocystic lesions on the face, including the nose.

  5. Females, regardless of childbearing potential:

    Must have a negative urine pregnancy test and if sexually active, must be on or use an acceptable method of birth control.

  6. Subjects must be willing to comply with sun avoidance measures for the face (as well as back/chest and shoulders, if applicable) including use of investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.
  7. Subject must be in good general health as determined by the investigator and supported by the medical history, physical examination, and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion criteria

Exclusion Criteria:

  1. Females who are pregnant or lactating or planning to become pregnant during the study period.

  2. Treatment with the following products:

    1. Topical acne treatments or other topical facial medication on the treatment area in the 14 days prior to the Baseline Visit, including prescription and non-prescription products.
    2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.
    3. Systemic retinoid use in the 180 days prior to the Baseline Visit.
    4. Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in the 30 days prior to the Baseline Visit. After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
    5. Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
    6. Treatment with an investigational product or device in the 30 days prior to the Baseline Visit.
  3. Known allergic reaction to retinoids or tazarotene or any of the other ingredients of these products.
  4. Presence of any facial skin disease or condition that would interfere with the study or place the subject at unacceptable risk including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition.
  5. Subjects with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
  1. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.
  1. Subjects who have been in another investigational trial within 30 days.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
547 participants (actual)

Study arms

  • Experimental
    DFD-03 Lotion (0.1% tazarotene)

    DFD-03 Lotion (0.1% tazarotene)

    Drug: DFD-03 (0.1% tazarotene) Lotion

  • Placebo comparator
    DFD-03 Vehicle (0% tazarotene)

    DFD-03 Vehicle Lotion (0% tazarotene)

    Drug: DFD-03 (0% tazarotene) Lotion (Placebo)

Interventions

  • DrugDFD-03 (0.1% tazarotene) Lotion

    DFD-03 Lotion (0.1% tazarotene) - twice daily application

    Also known as: DFD-03

  • DrugDFD-03 (0% tazarotene) Lotion (Placebo)

    DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application

    Also known as: Placebo

05

What researchers measure

Primary outcomes

  1. Absolute Change in the Inflammatory Lesion Counts on the Face

    Change in inflammatory lesion counts on the face from baseline to Week 12

    Time frame: Baseline to Week 12

  2. Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.

    IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)

    Time frame: Baseline to Week 12

  3. Absolute Change in the Non-inflammatory Lesion Counts on the Face

    Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model

    Time frame: Baseline to Week 12

06

Results

Posted Jun 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneDFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)
Started275272
Completed214230
Not completed6142
Withdrew: Withdrawal by subject1716
Withdrew: Adverse event202
Withdrew: Lost to follow-up2424

Outcome measures

PrimaryAbsolute Change in the Inflammatory Lesion Counts on the Face

Change in inflammatory lesion counts on the face from baseline to Week 12

Time frame:
Baseline to Week 12
Reported as:
Mean · Lesions
Absolute Change in the Inflammatory Lesion Counts on the Face
LesionsDFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)
Baseline29.4 ± 13.8229.7 ± 13.27
Week 1215.9 ± 12.1418.2 ± 16.58
PrimaryProportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.

IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)

Time frame:
Baseline to Week 12
Reported as:
Count of participants · Participants
Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.
ParticipantsDFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)
Proportion of Subjects With a Clinical Response of "Success" at Week 12 for Lesions on the Face Based on IGA.5826
PrimaryAbsolute Change in the Non-inflammatory Lesion Counts on the Face

Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the ANCOVA model

Time frame:
Baseline to Week 12
Reported as:
Mean · Lesions
Absolute Change in the Non-inflammatory Lesion Counts on the Face
LesionsDFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)
Baseline44.8 ± 33.9344.4 ± 27.75
Week 1224.3 ± 18.1329.7 ± 23.12

Adverse events

Collected over Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued (i.e. up to 12 weeks), except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DFD-03 Lotion (0.1% Tazarotene)0/275 (0%)2/275 (0.7%)0/275 (0%)
DFD-03 Vehicle (0% Tazarotene)0/272 (0%)0/272 (0%)0/272 (0%)
Most frequent serious events
Most frequent serious events
EventDFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)
Auto Accident with head traumaInjury, poisoning and procedural complications1/2750/272
Stomach UlcerGastrointestinal disorders1/2750/272

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)DFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)Total
<=18 years9385178
Between 18 and 65 years182187369
>=65 years000
Age, Continuous
Age, Continuous(years)DFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)Total
Mean20.7 ± 6.521.3 ± 7.621.0 ± 7.1
Sex: Female, Male
Sex: Female, Male(Participants)DFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)Total
Female143111254
Male132161293
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)Total
American Indian or Alaska Native112
Asian283260
Native Hawaiian or Other Pacific Islander314
Black or African American454085
White186186372
More than one race000
Unknown or Not Reported121224
Region of Enrollment
Region of Enrollment(participants)DFD-03 Lotion (0.1% Tazarotene)DFD-03 Vehicle (0% Tazarotene)Total
United States275272547
07

Study locations

1 site
  • Center for Dermatology Clinical Research Inc.
    Fremont, California 94538, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 2, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03292640
Lead sponsor
Dr. Reddy's Laboratories Limited
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Jul 6, 2017
Primary completion
May 14, 2018
Completion
May 14, 2018
Results posted
Jun 9, 2020
Last update
Mar 1, 2021

Study contacts

Srinivas R. Sidgiddi, M.D.
study director · Dr. Reddy's Laboratories

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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