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
Overview
- Phase
- Phase 3
- Intervention
- MAL Cream
- Conditions
- Keratosis, Actinic
- Sponsor
- Galderma R&D
- Enrollment
- 125
- Locations
- 43
- Primary Endpoint
- Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: MAL Cream
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.
Intervention: Vehicle cream
Outcomes
Primary Outcomes
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
Time Frame: At Week 54
Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to \[\>=\] 1) cleared treated AK lesions. Number of participants with recurrence of any (\>=1) cleared treated AK lesions at Week 54 was reported.
Secondary Outcomes
- Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54(At Week 28 and Week 54)
- Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28(At Week 28)