Overview

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