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

Official title

Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp

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.

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

Primary outcome measures

• Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area. [Time frame: Week 12]

Secondary outcome measures (11)

• Actinic Keratosis Clearance rate (AKCR) [Time frame: Week 12]
• Proportion of patients achieving clearance of target lesions in the Treatment Area [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 [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. [Time frame: Weeks 12, 20, and 24]
• Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24. [Time frame: Weeks 12, 20, and 24]
• Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24. [Time frame: Weeks 12, 20, and 24]
• Recurrence Rate at Week 24 [Time frame: Week 24]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 10 centers

• Center for Dermatology Clinical Research, Inc — Fremont
• Center for Clinical and Cosmetic Research — Aventura
• Arlington Dermatology — Rolling Meadows
• The Indiana Clinical Trials Center, PC — Plainfield
• Minnesota Clinical Study Center — New Brighton
• Medisearch, LLC — Saint Joseph
• Oregon Dermatology and Research Center — Portland
• Palmetto Clinical Trial Services, LLC — Greenville
• … and 2 more centers

Identifiers

NCT: NCT07144345 · LEV-21-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗