Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Sun Pharmaceutical Industries, Inc.
Study ID
NCT07144852
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 — OTHER
    Solution for topical use
  • Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. — DEVICE
    BLU-U® blue light 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 upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. 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 29, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Levulan
    Levulan application + incubation time (with occlusion) + blue light application
  • Placebo Comparator: Vehicle
    Vehicle application + incubation time (with occlusion) + 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 (20)

FacilityCityStateZIPSite coordinators
Medical Dermatology SpecialistPhoenixArizona85006-
Center for Dermatology Clinical Research, IncFremontCalifornia94538-
Clarity Dermatology, PLLCCastle RockColorado80109-
Center for Clinical and Cosmetic ResearchAventuraFlorida33180-
Ziaderm Research LLCNorth Miami BeachFlorida33162-
Northwest Clinical Trials, Inc.BoiseIdaho83704-
Arlington DermatologyRolling MeadowsIllinois60008-
The Indiana Clinical Trials Center, PCPlainfieldIndiana46168-
Minnesota Clinical Study CenterNew BrightonMinnesota55112-
Medisearch, LLCSaint JosephMissouri64506-
Oregon Dermatology and Research CenterPortlandOregon97210-
Dermatology Associates of Plymouth MeetingPlymouth MeetingPennsylvania19462-
Palmetto Clinical Trial Services, LLCAndersonSouth Carolina29621-
Palmetto Clinical Trial Services, LLCGreenvilleSouth Carolina29615-
Dermatology Associates of KnoxvilleKnoxvilleTennessee37909-
Tennessee Clinical Research CenterNashvilleTennessee37215-
J&S Studies, IncCollege StationTexas77845-
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical ResearchPflugervilleTexas78660-
Dermatology of Seattle & BellevueBurienWashington98168-
Premier Clinical ResearchSpokaneWashington99202-

Find similar trials in Phoenix, AZ

By research site
Medical Dermatology Specialist· Phoenix, AZCenter for Dermatology Clinical Research, Inc· Fremont, CAClarity Dermatology, PLLC· Castle Rock, COCenter for Clinical and Cosmetic Research· Aventura, FLZiaderm Research LLC· North Miami Beach, FLNorthwest Clinical Trials, Inc.· Boise, ID

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