Phase 3
Completed N=557
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
Source: ClinicalTrials.gov NCT04085367 ↗
Enrolled (actual)
557
Serious AEs
1.1%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With Complete Response at Week 12 — 25.3; 23.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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.
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. Informational only — not medical advice.