A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study

• Status: Completed
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

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