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

NCT07144345 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: LEV-21-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 10

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 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

Keywords

Blue Light Photodynamic Therapy; Skin Diseases; Precancerous Conditions; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid

Outcome Measures

Primary Outcomes (1)

• Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.

  Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared".

  Week 12

Secondary Outcomes (11)

• Actinic Keratosis Clearance rate (AKCR)

  Week 12

• Proportion of patients achieving clearance of target lesions in the Treatment Area

  Weeks 4, 8, 12, 20, and 24.

• Actinic Keratosis Clearance rate (AKCR)

  Weeks 4, 8, 20, and 24

• Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area

  Weeks 4, 8, 20, and 24

• Partial Clearance Rate (PCR); i.e., proportion of patients achieving partial clearance of AK lesions

  Weeks 4, 8, 12, 20, and 24

Study Arms (4)

Levulan + Incubation time 1

EXPERIMENTAL

Levulan application + Incubation time 1 + blue light application

Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Vehicle + Incubation time 1

PLACEBO COMPARATOR

Vehicle application + Incubation time 1 + blue light application

Other: Vehicle containing excipients only (VEH) without active ingredient; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Levulan + Incubation time 2

EXPERIMENTAL

Levulan application + Incubation time 2 + blue light application

Drug: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Vehicle + Incubation time 2

PLACEBO COMPARATOR

Vehicle application + Incubation time 2 + blue light application

Other: Vehicle containing excipients only (VEH) without active ingredient; Device: Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Interventions

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

Solution for topical use

Levulan + Incubation time 1; Levulan + Incubation time 2

Vehicle containing excipients only (VEH) without active ingredient OTHER

Solution for topical use

Vehicle + Incubation time 1; Vehicle + Incubation time 2

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

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

Levulan + Incubation time 1; Levulan + Incubation time 2; Vehicle + Incubation time 1; Vehicle + Incubation time 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (10)

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

RECRUITING

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

RECRUITING

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

RECRUITING

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

RECRUITING

Medisearch, LLC

Saint Joseph, Missouri, 64506, United States

RECRUITING

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

RECRUITING

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, 29615, United States

RECRUITING

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

RECRUITING

Premier Clinical Research

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic; Skin Diseases; Precancerous Conditions

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms; Keratosis; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Head, Regulatory Affairs

CONTACT

9122 66455645; Clinical.Trial@sunpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, investigator and outcomes assessor are blinded to treatment assignment, as both Levulan and Vehicle products look identical and cannot be differentiated from the application characteristics.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (10)