Phase 3 N=557 Randomized Triple-blind Treatment

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

Actinic Keratoses

Bottom Line

View on ClinicalTrials.gov: NCT04085367 ↗

Enrolled (actual)

557

Serious AEs

1.1%

Results posted

Apr 2022

Primary outcome: Primary: Percentage of Participants With Complete Response at Week 12 — 25.3; 23.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MAL 16.8% cream (Drug); MAL Vehicle Cream (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Complete Response at Week 12	25.3; 23.0	—
SECONDARY Percent Change From Baseline in Lesion Complete Response at Week 12	-61.1; -49.4	—
SECONDARY Percentage of Participants With Partial Response at Week 12	48.2; 35.1	—

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).

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04085367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.