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

Completed · Phase 3

Conditions studied: Actinic Keratoses

In brief

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).

Key facts

Study ID

NCT04085367

Run by

Galderma R&D

People needed

557

Starts

2019-09-30

Expected to finish

2021-04-07

Last updated by the study team

2022-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Galderma Investigational Site (Site 8479) — Bradenton, Florida, United States
• Galderma Investigational Site (Site 8770) — Lehigh Acres, Florida, United States
• Galderma Investigational Site (Site 8656) — Miami, Florida, United States
• Galderma Investigational Site (Site 8765) — North Miami Beach, Florida, United States
• Galderma Investigation Site (Site 8769) — Palm Springs, Florida, United States
• Galderma Investigational Site (Site 8734) — Pembroke Pines, Florida, United States
• Galderma Investigational Site (Site 8529) — Sanford, Florida, United States
• Galderma Investigational Site (Site 8126) — West Palm Beach, Florida, United States
• Galderma Investigational Site (Site 8683) — Atlanta, Georgia, United States
• Galderma Investigational Site (Site 8860) — Atlanta, Georgia, United States
• Galderma Investigational Site (Site 8667) — Columbus, Georgia, United States
• Galderma Investigational Site (Site 8755) — Boise, Idaho, United States
• Galderma Investigational Site (Site 8838) — Darien, Illinois, United States
• Galderma Investigational Site (Site 8724) — Louisville, Kentucky, United States
• Galderma Investigational Site (Site 8208) — Beverly, Massachusetts, United States
• Galderma Investigational Site (Site 8768) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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