Title
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage
Phase
Phase 2Lead Sponsor
Fundación DermabaseStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Facial PhotodamageIntervention/Treatment
methyl aminolevulinate ...Study Participants
60Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage
1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
Inclusion Criteria: Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale) Patients willing to participate Signed informed consent Exclusion Criteria: Pregnant or nursing females Subjects with any photosensitizing disorder Any active infectious skin disorder History of herpes simplex in the face Subjects with less than 6 months of any previous rejuvenation interfering treatments History of systemic isotretinoin in the last year Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments History of hypersensitivity reactions Activities with high sun exposure during 48 hours after treatment Clinical suspicion of any systemic or local malignancy