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 (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)
ClinicalTrials.gov processed this data on March 7, 2022. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified March 2022 by Galderma R&D
Sponsor
Galderma R&DInformation Provided by (Responsible Party)
Galderma R&DClinicaltrials.gov Identifier
NCT04085367Other Study ID Numbers: RD.06.SPR.112199
First Submitted: September 9, 2019
First Posted: September 11, 2019
Results First Posted: April 1, 2022
Last Update Posted: April 1, 2022
Last Verified: March 2022
History of Changes
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Study 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.| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 557 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| Official Title | 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 (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT) |
| Study Start Date | September 30, 2019 |
| Actual Primary Completion Date | March 3, 2021 |
| Actual Study Completion Date | April 7, 2021 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Complete Response at Week 12 [Week 12] Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Secondary Outcome Measures
- Percent Change From Baseline in Lesion Complete Response at Week 12 [Baseline, Week 12] Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream.
- Percentage of Participants With Partial Response at Week 12 [Week 12] Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream.
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Galderma R&D |
|---|---|
| Locations |
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Study Documents (Full Text)
- Documents Provided by Galderma R&D: Study Protocol July 12, 2020
- Documents Provided by Galderma R&D: Statistical Analysis Plan April 6, 2021
More Information
Additional Relevant MeSH Terms
- Keratosis, Actinic
- Keratosis
- Skin Diseases
- Precancerous Conditions
- Neoplasms