A Phase 3 interventional study of Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% and Vehicle containing excipients only (VEH) without active ingredient in Actinic Keratosis, sponsored by Sun Pharmaceutical Industries, Inc.. Recruiting at 12 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Sun Pharmaceutical Industries, Inc. · Phase 3, Interventional, and Treatment
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Sun Pharmaceutical Industries, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levulan application + Incubation time 1 + blue light application
Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% · Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Vehicle application + Incubation time 1 + blue light application
Other: Vehicle containing excipients only (VEH) without active ingredient · Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Levulan application + Incubation time 2 + blue light application
Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% · Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Vehicle application + Incubation time 2 + blue light application
Other: Vehicle containing excipients only (VEH) without active ingredient · Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Solution for topical use
Solution for topical use
BLU-U® blue light Photodynamic Therapy (PDT) illuminator
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared".
Time frame: Week 12
Actinic Keratosis Clearance rate (AKCR)
AKCR for each patient is calculated as 100 x \[1- (number of target AK lesions present at that particular visit/ number of target AK lesions present at Baseline)\]. Target lesions are those AK lesions that were identified at baseline and treated at baseline.
Time frame: Week 12
Proportion of patients achieving clearance of target lesions in the Treatment Area
Target lesions are those AK lesions that were identified at baseline and treated at baseline.
Time frame: Weeks 4, 8, 12, 20, and 24.
Actinic Keratosis Clearance rate (AKCR)
AKCR for each patient is calculated as 100 x \[1- (number of target AK lesions present at that particular visit/ number of target AK lesions present at Baseline)\]. Target lesions are those AK lesions that were identified at baseline and treated at baseline.
Time frame: Weeks 4, 8, 20, and 24
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area
Time frame: Weeks 4, 8, 20, and 24
Partial Clearance Rate (PCR); i.e., proportion of patients achieving partial clearance of AK lesions
Partial clearance is defined as clearance of at least 75% of all AK lesions in the Treatment Area; lesions should no longer be palpable nor visible to be declared as "cleared".
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion count from Baseline to Weeks 4, 8, 12, 20, and 24.
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.
Time frame: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.
The overall cosmetic response to treatment will be assessed by a Blinded Investigator using a 4-point scale, selecting the score that best describes the patient's cosmetic outcome in actinic keratosis since treatment initiation: 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor.
Time frame: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.
The patient's overall cosmetic response to treatment will be measured by the patient on a 4-point scale, where 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor
Time frame: Weeks 12, 20, and 24
Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.
The patient's overall satisfaction with the study treatment will be assessed using a 4-point patient-reported scale, where 0 = Not satisfied at all, 1 = Slightly satisfied, 2 = Moderately satisfied, and 3 = Very satisfied.
Time frame: Weeks 12, 20, and 24
Recurrence Rate at Week 24
Measured as proportion of patients presenting with at least 1 recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.
Time frame: Week 24
Started Nov 2025 (actual). Primary completion is estimated for Jan 2027, 14 months after the start.
Of 26 phase 3 interventional studies under Keratosis, Actinic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's planned 14 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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