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

Phase 3RecruitingNCT07144345

Sun Pharmaceutical Industries, Inc.160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Actinic Keratosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is a male or non-pregnant female aged 18-85 years. 2. 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. \[The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)\] 3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study. 4. 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. 5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile. Exclusion Criteria: 1. Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area. 2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year. 3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins. 4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result 5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects. 6. 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. 7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization. 8. Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization. 9. Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year. 10. Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.

Locations (10)

Center for Dermatology Clinical Research, Inc

Fremont, California, United States

RECRUITING

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

RECRUITING

Arlington Dermatology

Rolling Meadows, Illinois, United States

RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

RECRUITING

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

RECRUITING

Medisearch, LLC

Saint Joseph, Missouri, United States

RECRUITING

Oregon Dermatology and Research Center

Portland, Oregon, United States

RECRUITING

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, United States

RECRUITING

Tennessee Clinical Research Center

Nashville, Tennessee, United States

RECRUITING

Premier Clinical Research

Spokane, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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".

Time frame: Week 12

Secondary Outcomes

Actinic Keratosis Clearance rate (AKCR)

AKCR for each patient is calculated as 100 x \[1- (number of target AK lesions present at that particular visit/ number of target AK lesions present at Baseline)\]. Target lesions are those AK lesions that were identified at baseline and treated at baseline.

Time frame: Week 12

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

Target lesions are those AK lesions that were identified at baseline and treated at baseline.

Time frame: Weeks 4, 8, 12, 20, and 24.

Actinic Keratosis Clearance rate (AKCR)

Time frame: 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

Time frame: Weeks 4, 8, 20, and 24

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

Partial clearance is defined as clearance of at least 75% of all AK lesions in the Treatment Area; lesions should no longer be palpable nor visible to be declared as "cleared".

Time frame: Weeks 4, 8, 12, 20, and 24

Percent change in total AK lesion count from Baseline to Weeks 4, 8, 12, 20, and 24.

Time frame: Weeks 4, 8, 12, 20, and 24

Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.

Time frame: Weeks 8, 12, and 24

Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.

The overall cosmetic response to treatment will be assessed by a Blinded Investigator using a 4-point scale, selecting the score that best describes the patient's cosmetic outcome in actinic keratosis since treatment initiation: 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor.

Time frame: Weeks 12, 20, and 24

Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.

The patient's overall cosmetic response to treatment will be measured by the patient on a 4-point scale, where 1 = Excellent, 2 = Good, 3 = Fair, and 4 = Poor

Time frame: Weeks 12, 20, and 24

Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.

The patient's overall satisfaction with the study treatment will be assessed using a 4-point patient-reported scale, where 0 = Not satisfied at all, 1 = Slightly satisfied, 2 = Moderately satisfied, and 3 = Very satisfied.

Time frame: Weeks 12, 20, and 24

Recurrence Rate at Week 24

Measured as proportion of patients presenting with at least 1 recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.

Time frame: Week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts