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

Galderma

Status and phase: Completed; Phase 3

Conditions: Actinic Keratoses

Treatments: Drug: MAL Vehicle Cream; Drug: MAL 16.8% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085367

RD.06.SPR.112199

Details and patient eligibility

About

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).

Full 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.

Enrollment: 557 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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557 participants in 2 patient groups, including a placebo group

MAL 16.8% Cream

Experimental group

Description:

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.

Treatment:

Drug: MAL 16.8% cream

MAL Vehicle Cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: MAL Vehicle Cream