title: Topical methyl aminolaevulinate photodynamic therapy for treatment of facial acne vulgaris: results of a randomized, controlled study.
abstract: BACKGROUND
  There is a need for alternative treatments for moderate to severe acne vulgaris. Preliminary experience suggests that topical methyl aminolaevulinate photodynamic therapy (MAL-PDT) may have potential.
  
  
  OBJECTIVE
  To investigate the efficacy and tolerability of MAL-PDT for treatment of moderate inflammatory facial acne.
  
  
  METHODS
  Thirty patients aged 15-28 years with moderate to severe acne were included in a blinded, prospective, randomized, placebo-controlled multicentre study. Each side of each patient's face was randomly assigned to treatment with MAL (160 mg g1) or placebo cream, applied for 3 h prior to illumination. A second treatment was given 2 weeks later. On each occasion, patients assessed the intensity of pain using a 10-cm visual analogue scale. Inflammatory and noninflammatory acne lesions were counted at baseline and 4 and 10 weeks after the last PDT treatment. The investigator assessed the global severity of acne at baseline (seven patients had severe acne on at least one side of the face) and each study visit using a six-point rating scale. Data were analysed on an intention-to-treat basis, including all 30 patients.
  
  
  RESULTS
  There was a statistically significant greater reduction in the total inflammatory lesion count with MAL-PDT compared with placebo PDT at week 12; median reduction 54% [95% confidence interval (CI) 35-64%] vs. 20% (95% CI 8-50%), P = 0.0006. MAL-PDT was associated with more pain than placebo PDT, although intensity varied across centres and was reduced with repeated treatment. Local adverse events were consistent with this treatment modality.
  
  
  CONCLUSIONS
  MAL-PDT is effective in the treatment of moderate to severe inflammatory facial acne. Further studies are warranted to optimize this promising procedure.
authors.affiliation: Department of Dermatology, Sahlgrenska University Hospital, 41435 Gothenburg, Sweden. camilla.s.horfelt@vgregion.se
authors.forename: C
authors.initials: C
authors.lastname: Hörfelt
authors.forename: J
authors.initials: J
authors.lastname: Funk
authors.forename: M
authors.initials: M
authors.lastname: Frohm-Nilsson
authors.forename: D
authors.initials: D
authors.lastname: Wiegleb Edström
authors.forename: A-M
authors.initials: AM
authors.lastname: Wennberg
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000622:Aminolevulinic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid