Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

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

Details

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

Criteria

Inclusion Criteria:

• Female subjects older than 35 years of age and less than 75 years of age

• Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale

• Subjects willing to participate according to protocol requirements.

• Patients with signed Informed Consent

• Patients with no exclusion criteria

Exclusion Criteria:

• Pregnant or nursing females.

• Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.

• Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )

• Subjects with less than 6 months of previous rejuvenation interfering treatments

• Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.