title: Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial.
abstract: BACKGROUND
  Daylight photodynamic therapy (DL-PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c-PDT), using methyl aminolevulinate (MAL) cream.
  
  
  OBJECTIVE
  To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK.
  
  
  METHODS
  This 24-week randomized, controlled, investigator-blinded, multicentre, intra-individual efficacy (non-inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary end points for DL-PDT at week 12 were efficacy [non-inferiority regarding complete lesion response (mild AK)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire.
  
  
  RESULTS
  At week 12, the complete lesion response rate with DL-PDT was non-inferior to c-PDT (89·2% vs. 92·8%, respectively; 95% confidence interval -6·8 to -0·3), confirmed by intention-to-treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the PDT session. For DL-PDT, subject-reported pain was significantly lower (0·8 vs. 5·7, respectively; P < 0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome.
  
  
  CONCLUSIONS
  Daylight-mediated PDT was not inferior in efficacy to Metvix c-PDT (mild AK response rate), better tolerated, nearly painless and more convenient for patients.
authors.affiliation: Woden Dermatology and Probity Medical Research, Level 1, 1 Bowes Place, Phillip, ACT, 2606, Australia; Australian National University, Canberra, Australia.
authors.forename: D M
authors.initials: DM
authors.lastname: Rubel
authors.forename: L
authors.initials: L
authors.lastname: Spelman
authors.forename: D F
authors.initials: DF
authors.lastname: Murrell
authors.forename: J-A
authors.initials: JA
authors.lastname: See
authors.forename: D
authors.initials: D
authors.lastname: Hewitt
authors.forename: P
authors.initials: P
authors.lastname: Foley
authors.forename: C
authors.initials: C
authors.lastname: Bosc
authors.forename: D
authors.initials: D
authors.lastname: Kerob
authors.forename: N
authors.initials: N
authors.lastname: Kerrouche
authors.forename: H C
authors.initials: HC
authors.lastname: Wulf
authors.forename: S
authors.initials: S
authors.lastname: Shumack
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009824:Ointments; D010146:Pain / Q000517:prevention & control; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009824:Ointments; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid