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

NCT07144345 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%

Solution for topical use

OTHER

Vehicle containing excipients only (VEH) without active ingredient

Solution for topical use

DEVICE

Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-19
Primary Completion
2027-01-31
Completion
2027-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144345 on ClinicalTrials.gov