At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 557 enrolled
Drug / intervention
MAL 16.8% cream +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating MAL 16.8% cream and MAL Vehicle Cream for Actinic Keratoses. Completed, enrolled 557 participants across 60 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartSep 2019
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedSep 11, 2019
Enrollment StartSep 30, 2019
Primary CompletionMar 3, 2021
Study CompletionApr 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.8 years ago
Interventions
MAL 16.8% creamdrug
Day light photodynamic therapy with MAL 16.8% cream
MAL Vehicle Creamdrug
Day light photodynamic therapy with MAL vehicle cream