Status:
COMPLETED
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
Lead Sponsor:
Galderma R&D
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT04085367
Start Date
September 30 2019
End Date
April 7 2021
Last Update
April 1 2022
Active Locations (60)
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1
Galderma Investigational Site (Site 8768)
Tucson, Arizona, United States, 85718
2
Galderma Investigational Site (Site 8447)
Fort Smith, Arkansas, United States, 72916-6103
3
Galderma Investigational Site (Site 8577)
Encinitas, California, United States, 92024
4
Galderma Investigational Site (Site 8636)
Fountain Valley, California, United States, 92708