Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp

Part of paid clinical trials in Fremont, California.

Sponsor
Sun Pharmaceutical Industries, Inc.
Study ID
NCT07144345
Phase
PHASE3
Status
Recruiting
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Conditions

  • Actinic Keratosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% — DRUG
    Solution for topical use
  • Vehicle containing excipients only (VEH) without active ingredient — OTHER
    Solution for topical use
  • Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E — DEVICE
    BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Study Details

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.

Key Dates

Start date
Nov 19, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Levulan + Incubation time 1
    Levulan application + Incubation time 1 + blue light application
  • Placebo Comparator: Vehicle + Incubation time 1
    Vehicle application + Incubation time 1 + blue light application
  • Experimental: Levulan + Incubation time 2
    Levulan application + Incubation time 2 + blue light application
  • Placebo Comparator: Vehicle + Incubation time 2
    Vehicle application + Incubation time 2 + blue light application

Primary Outcome Measure

Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area. [ Time Frame: Week 12 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Center for Dermatology Clinical Research, IncFremontCalifornia94538-
Center for Clinical and Cosmetic ResearchAventuraFlorida33180-
Arlington DermatologyRolling MeadowsIllinois60008-
The Indiana Clinical Trials Center, PCPlainfieldIndiana46168-
Minnesota Clinical Study CenterNew BrightonMinnesota55112-
Medisearch, LLCSaint JosephMissouri64506-
Oregon Dermatology and Research CenterPortlandOregon97210-
Palmetto Clinical Trial Services, LLCGreenvilleSouth Carolina29615-
Tennessee Clinical Research CenterNashvilleTennessee37215-
Premier Clinical ResearchSpokaneWashington99202-

Find similar trials in Fremont, CA

By research site
Center for Dermatology Clinical Research, Inc· Fremont, CACenter for Clinical and Cosmetic Research· Aventura, FLArlington Dermatology· Rolling Meadows, ILThe Indiana Clinical Trials Center, PC· Plainfield, INMinnesota Clinical Study Center· New Brighton, MNMedisearch, LLC· Saint Joseph, MO

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