Levulan Kerastick + PDT for Actinic Keratosis

Recruiting at 9 trial locations

Overseen By Head, Regulatory Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sun Pharmaceutical Industries, Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 85 years old and not pregnant.

I have 4-8 mild to moderate skin lesions on my face or scalp.

I agree to not use any skin products in the treatment area 8 hours before clinic visits.

What Are the Treatments Tested in This Trial?

Interventions

• Reformulated Levulan Kerastick

How Is the Trial Designed?

Group I: Levulan + Incubation time 2 Experimental Treatment 2 Interventions

Levulan application + Incubation time 2 + blue light application

Group II: Levulan + Incubation time 1 Experimental Treatment 2 Interventions

Levulan application + Incubation time 1 + blue light application

Group III: Vehicle + Incubation time 2 Placebo Group 2 Interventions

Vehicle application + Incubation time 2 + blue light application

Group IV: Vehicle + Incubation time 1 Placebo Group 2 Interventions

Vehicle application + Incubation time 1 + blue light application

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries, Inc.

Lead Sponsor