Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
- Conditions
- Actinic Keratoses
- Interventions
- Drug: MAL 16.8% creamDrug: MAL Vehicle Cream
- Registration Number
- NCT04085367
- Lead Sponsor
- Galderma R&D
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 557
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAL 16.8% Cream 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. MAL Vehicle Cream 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Response at Week 12 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 Outcome Measures
Name Time Method Percent Change From Baseline in Lesion Complete Response at Week 12 Baseline, Week 12 Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream.
Percentage of Participants With Partial Response at Week 12 Week 12 Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream.
Trial Locations
- Locations (60)
Galderma Investigational Site (Site 8768)
🇺🇸Tucson, Arizona, United States
Galderma Investigational Site (Site 8447)
🇺🇸Fort Smith, Arkansas, United States
Galderma Investigational Site (Site 8577)
🇺🇸Encinitas, California, United States
Galderma Investigational Site (Site 8636)
🇺🇸Fountain Valley, California, United States
Galderma Investigational Site (Site 8224)
🇺🇸Fremont, California, United States
Galderma Investigational Site (Site 8114)
🇺🇸Fresno, California, United States
Galderma Investigational Site (Site 8758)
🇺🇸San Diego, California, United States
Galderma Investigational Site (Site 8608)
🇺🇸Santa Monica, California, United States
Galderma Investigational Site (Site 8778)
🇺🇸Denver, Colorado, United States
Galderma Investigational Site (Site 8440)
🇺🇸Greenwood Village, Colorado, United States
Scroll for more (50 remaining)Galderma Investigational Site (Site 8768)🇺🇸Tucson, Arizona, United States