The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
Full Title of Study: “A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or 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), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199″
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: June 30, 2020
This is a double-blind, multicenter, long-term follow-up study. The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream (CD06809-41) or 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), for participants achieving complete response of treated lesions at Final Visit in Study RD.06.SPR.112199 (NCT04085367).
- Drug: MAL Cream
- No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
- Drug: Vehicle cream
- No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
Arms, Groups and Cohorts
- Active Comparator: MAL Cream Arm
- Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
- Placebo Comparator: Vehicle Cream Arm
- Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
Clinical Trial Outcome Measures
- Proportion of Participants with Recurrence of Any (>=1) Cleared Treated Actinic Keratosis (AK) Lesions at Visit 3
- Time Frame: VIsit 3 (52 weeks after last DL-PDT treatment)
- Proportion of participants with recurrence of any (greater than or equal to [>=]1) cleared treated AK lesions at Visit 3 that is 52 weeks after the last daylight photodynamic therapy (DL-PDT) treatment will be reported.
- Lesion Recurrence
- Time Frame: Visits 2 and 3 (26 and 52 weeks after the last DL-PDT treatment )
- Lesion recurrence (percentage of cleared treated lesions) at Visits 2 and 3 after the last DL-PDT treatment will be reported.
- Proportion of Participants with Recurrence of Any (>=1) Cleared Treated AK Lesions at Visit 2
- Time Frame: VIsit 2 (26 weeks after last DL-PDT treatment)
- Proportion of participants with recurrence of any (>=1) cleared treated AK lesions at Visit 2 that is 26 weeks after the last DL-PDT treatment will be reported.
Participating in This Clinical Trial
- Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and achieved complete response at last visit
- Participants fully understand and sign an informed consent form (ICF) before any study procedure begins
- Participants willing and able to perform all study protocol requirements
- Participants developing or experiencing any condition that may not be safe for them or not compliant will be excluded
- Pertinent not compliant with study conditions or PI instructions during the earlier study – Lumexia Ph 3
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Galderma R&D
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Galderma Research & Development, 817-961-5000, email@example.com
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