Status:
NOT_YET_RECRUITING
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 photod...
Eligibility Criteria
Inclusion
- Patient is a male or non-pregnant female aged 18-85 years.
- Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. \[The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)\]
- Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.
- Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
Exclusion
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
- Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization.
- Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.
- Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.
- Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year.
- Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07144345
Start Date
September 1 2025
End Date
September 24 2026
Last Update
August 27 2025
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