A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 557
- Locations
- 60
- Primary Endpoint
- Percentage of Participants With Complete Response at Week 12
Study Overview
Brief Summary
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
Detailed Description
This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged ≥ 18 years at the Screening visit.
- •Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.
- •Female Participants of non-childbearing potential.
- •Participants fully understood and signed an ICF before any investigational procedure(s) are performed.
Exclusion Criteria
- •Participants with pigmented AK in the treatment areas.
- •Female participants who were pregnant, nursing, or planning a pregnancy during the study.
- •Participants with a clinical diagnosis of a skin disease other than AK.
- •Immunocompromised participants.
- •Participants with any condition that may be associated with a risk of poor protocol compliance.
Arms & Interventions
MAL 16.8% Cream
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
Intervention: MAL 16.8% cream (Drug)
MAL Vehicle Cream
Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.
Intervention: MAL Vehicle Cream (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Complete Response at Week 12
Time Frame: Week 12
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Secondary Outcomes
- Percent Change From Baseline in Lesion Complete Response at Week 12(Baseline, Week 12)
- Percentage of Participants With Partial Response at Week 12(Week 12)