title: Photodynamic therapy with methyl aminolaevulinate 80 mg g(-1) for severe facial acne vulgaris: a randomized vehicle-controlled study.
abstract: BACKGROUND
  Severe acne vulgaris has limited therapeutic options.
  
  
  OBJECTIVE
  To evaluate photodynamic therapy (PDT) using topical methyl aminolaevulinate (MAL, 80 mg g(-1) ) as the photosensitizer in severe facial acne.
  
  
  METHODS
  A double-blind, randomized, vehicle-controlled multicentre trial in 153 patients (aged 12-35 years) with severe facial acne [Investigator's Global Assessment (IGA) score 4; 25-75 inflammatory lesions with ≤ 3 nodules; 20-100 noninflammatory lesions]. Treatment (four treatments 2 weeks apart) involved incubation with MAL (n = 100) or vehicle cream (n = 53) for 1·5 h under occlusion, then illumination (635-nm red light, total dose 37 J cm(-2) ). IGA assessment and standardized lesion counts were performed before each treatment and 12 weeks after the first treatment. Treatment success was defined as improvement from baseline in IGA by ≥ 2 grades at 12 weeks. Safety assessments were for pain (10-cm visual analogue scale, immediately after illumination), erythema (four-point rating scale) and adverse events.
  
  
  RESULTS
  At 12 weeks, PDT using MAL 80 mg g(-1) reduced inflammatory lesions vs. vehicle PDT (mean change -15·6 vs. -7·8, P = 0·006; mean percentage change -37·3% vs. -16·2%, P = 0·003). However, noninflammatory lesions did not decrease significantly (mean change -11·8 vs. -10·7, P = 0·85; mean percentage change -28·6% vs. -24·9%, P = 0·72). Treatment success rates were greater with MAL-PDT 80 mg g(-1) (44% vs. 26%, P = 0·013). Pain was low and manageable by briefly pausing illumination. There was similar pain or erythema with successive treatments.
  
  
  CONCLUSIONS
  PDT using topical MAL 80 mg g(-1) and red light may offer promise for severe acne vulgaris.
authors.affiliation: Eastern Virginia Medical School, Division of Dermatology, and Virginia Clinical Research Inc., 6161 Kempsville Circle, Suite 200A, Norfolk, VA, 23502, U.S.A.
authors.forename: D M
authors.initials: DM
authors.lastname: Pariser
authors.affiliation: Rady Children's Hospital San Diego and University of California, San Diego, CA, U.S.A.
authors.forename: L F
authors.initials: LF
authors.lastname: Eichenfield
authors.affiliation: Altman Dermatology Associates, Arlington Heights, IL, U.S.A.
authors.forename: M
authors.initials: M
authors.lastname: Bukhalo
authors.affiliation: Deaconess Clinic, Inc., Evansville, IN, U.S.A.
authors.forename: G
authors.initials: G
authors.lastname: Waterman
authors.affiliation: DermResearch, Inc., Austin, TX, U.S.A.
authors.forename: M
authors.initials: M
authors.lastname: Jarratt
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D009824:Ointments / Q000008:administration & dosage; D010146:Pain / Q000209:etiology; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009824:Ointments; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid