Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Dermabase
• Collaborators: Grupo de Investigacion Dermatologica (GRID); IPS Universitaria-Universidad de Antioquia
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

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