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

• Status: Completed
• Trial end date: 2021-04-07
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

• Subjects aged ≥ 18 years at the Screening visit

• Subjects have 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 subjects of non-childbearing potential

• Subject fully understands and signs an ICF before any investigational procedure(s) are performed

Exclusion Criteria:

• Subjects with pigmented AK in the treatment areas

• Female subjects who are pregnant, nursing, or planning a pregnancy during the study

• Subjects with a clinical diagnosis of a skin disease other than AK

• Immunocompromised subjects

• Subjects with any condition that may be associated with a risk of poor protocol compliance