title: A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage.
abstract: BACKGROUND
  To date, there is no gold standard therapy for skin photoageing. In the last decade, laser technologies have offered great promise among skin-rejuvenation therapies; however, both non-ablative and ablative fractional resurfacing modalities have their own benefits and drawbacks. More recently, open-label studies and few controlled trials have suggested that photodynamic therapy may have therapeutic potential in photodamage.
  
  
  OBJECTIVE
  To assess the efficacy of methyl aminolevulinate + red-light on facial photodamage in a double-blind split-face randomized placebo-controlled trial.
  
  
  METHODS
  Subjects had initially two split-face treatments 2-3 weeks apart in which half of the face was treated with MAL + red-light compared with placebo + red-light. Primary outcome was the assessment of global photodamage 1 month after session 2. Secondary outcomes included the assessment of fine lines, mottled pigmentation, tactile roughness, sallowness, erythema and telangiectasia 1 month after session 2, according to severity scores rated as failure, improvement or success.
  
  
  RESULTS
  Based on the intention-to-treat analysis, a total of 48 patients (96 split-faces) were included. Facial global photodamage success or improvement had occurred in 94 split-faces and in no split-faces receiving placebo (RR: 0.02; 95% confidence interval, 0.0-0.14; P = 0.0000). One patient had an adverse event that led to the discontinuation of the therapy after session 1.
  
  
  CONCLUSIONS
  Methyl aminolevulinate + red-light demonstrated significantly superior efficacy in global facial photodamage compared with placebo. This therapy was also useful for all other specific secondary outcomes, except for telangiectasia. Overall, MAL + red-light sessions were well tolerated and resulted in high/total patient satisfaction in the majority of subjects (80.4%).
authors.affiliation: Group of Investigative Dermatology - GRID, Dermatology Section, Department of Internal Medicine, School of Medicine, University of Antioquia, Medellín, Colombia. gsanclemente@une.net.co
authors.forename: G
authors.initials: G
authors.lastname: Sanclemente
authors.forename: L
authors.initials: L
authors.lastname: Medina
authors.forename: J-F
authors.initials: JF
authors.lastname: Villa
authors.forename: L-M
authors.initials: LM
authors.lastname: Barrera
authors.forename: H-I
authors.initials: HI
authors.lastname: Garcia
mesh_terms: D000328:Adult; D000622:Aminolevulinic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D005145:Face; D005260:Female; D006801:Humans; D008875:Middle Aged; D010789:Phototherapy / Q000009:adverse effects; D010919:Placebos; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects* / Q000528:radiation effects
chemical_list: D010919:Placebos; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid