title: A double-blind randomized controlled trial to assess the efficacy of daylight photodynamic therapy with methyl-aminolevulinate vs. Placebo and daylight in patients with facial photodamage.
abstract: BACKGROUND
  Daylight PDT (dPDT) is easy to use and does not require light equipment. Such therapy has been exhaustively proved to be successful in the treatment of actinic keratosis, but its use in skin photodamage remains unclear.
  
  
  OBJECTIVE
  To evaluate dPDT's efficacy in skin facial photodamage.
  
  
  METHODS
  This was a parallel-group double-blind, randomized placebo-controlled trial. Sixty participants with symmetric facial photodamage were allocated to topical methyl aminolevulinate (MAL) and daylight vs. matching placebo and daylight. Primary outcome was global photodamage improvement/failure 1 month after the third session. Secondary outcomes included: pain evaluation; specific photodamage severity scores; sun irradiance quantification and Skindex-29 scores. Adverse events were also investigated.
  
  
  RESULTS
  Primary analysis included all randomized patients. All patients sun-exposed for 120min in 3 sessions. The risk of failure was lower in the MAL-dPDT group than in the placebo plus daylight group (RR: 0.18; 95% CI: 0.08-0.41). Mean solar irradiance (W/m(2)) during the first, second and third sessions was 480.82, 430.07 and 435.84, respectively. Items 5 and 14 of Skindex-29 in the MAL-dPDT group showed statistical significant differences. Two patients in the MAL-dPDT group had serious and non-serious events not directly related to the product.
  
  
  CONCLUSIONS
  dPDT with MAL was un-painful, effective and safe for the treatment of facial photodamage. Herpes simplex prophylaxis should be considered before sessions.
authors.affiliation: IPS Universitaria, Universidad de Antioquia, Medellín, Colombia; Grupo de Investigación Dermatológica (GRID), Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia. Electronic address: sanclementegloria@gmail.com.
authors.forename: G
authors.initials: G
authors.lastname: Sanclemente
authors.affiliation: Grupo de Investigación Dermatológica (GRID), Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
authors.forename: G A
authors.initials: GA
authors.lastname: Mancilla
authors.affiliation: Grupo de Investigación Dermatológica (GRID), Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellín, Colombia.
authors.forename: G
authors.initials: G
authors.lastname: Hernandez
mesh_terms: D000622:Aminolevulinic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D006801:Humans; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D015595:Skin Aging / Q000528:radiation effects*; D013472:Sunlight
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid
keywords: Daylight; Ensayo Clínico Controlado con Asignación Aleatoria; Fotodaño; Luz del día; Photodamage; Photodynamic therapy; Randomized-controlled-trial; Terapia fotodinámica