Trials / Completed
CompletedNCT04085367
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
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 557 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MAL 16.8% cream | Day light photodynamic therapy with MAL 16.8% cream |
| DRUG | MAL Vehicle Cream | Day light photodynamic therapy with MAL vehicle cream |
Timeline
- Start date
- 2019-09-30
- Primary completion
- 2021-03-03
- Completion
- 2021-04-07
- First posted
- 2019-09-11
- Last updated
- 2022-04-01
- Results posted
- 2022-04-01
Locations
60 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04085367. Inclusion in this directory is not an endorsement.