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 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    60
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
Study Started
Apr 30
2014
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Last Update
Mar 06
2015
Estimate

Drug Methyl Aminolevulinate (MAL)

  • Other names: Metvix®

Drug Placebo

  • Other names: Vehicle

Methyl Aminolevulinate (MAL) Experimental

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)

Placebo Placebo Comparator

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)

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
No Results Posted