title: Daylight photodynamic therapy for actinic keratoses: a randomized double-blinded nonsponsored prospective study comparing 5-aminolaevulinic acid nanoemulsion (BF-200) with methyl-5-aminolaevulinate.
abstract: BACKGROUND
  Daylight-mediated photodynamic therapy (DL-PDT) using methyl-5-aminolaevulinate (MAL) is effective for thin, grade I, actinic keratoses (AK). There are no published studies of other photosensitizers used in DL-PDT.
  
  
  OBJECTIVE
  To compare the efficacy and adverse effects of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) with MAL in DL-PDT of grade I-III AKs.
  
  
  METHODS
  In 13 patients, 177 AKs were randomized symmetrically for a split-face prospective observer-blinded study and received either BF-200 ALA or MAL DL-PDT. Grade I AKs were treated once and grade II-III AKs twice with a 0·25-mm layer of photosensitizer precursors. Pain was assessed during and after the daylight exposure. Efficacy at 3 months was assessed clinically and histologically.
  
  
  RESULTS
  BF-200 ALA cleared 71/84 (84·5%) and MAL 69/93 (74·2%) of the AKs (P = 0·099), all grades responding equally, but with new AKs appearing during follow-up (n = 4, BF-200 ALA; n = 8, MAL). In per patient half-face analysis BF-200 ALA showed significantly higher clearance rates for grade I AKs than did MAL (P = 0·027), but for thicker grades, clearance was equal (P = 0·564). BF-200 ALA and MAL treatments resulted in 61·5% and 38·5% complete histological clearance (P = 0·375), respectively. p53 expression decreased by 54·4% and 33·7%, respectively (P = 0·552). Both treatments were nearly painless with similar adverse reactions and no difference in patient preference.
  
  
  CONCLUSIONS
  BF-200 ALA showed a trend towards improved efficacy results compared with MAL. Thicker lesions in both groups responded when treated repeatedly. Importantly, a thin 0·25-mm layer of the photosensitizer precursors was sufficient, which may lead to lower expense.
authors.affiliation: Department of Dermatology and Allergology, Helsinki University Central Hospital, Helsinki, Finland; Department of Dermatology and Allergology, Päijät-Häme Social and Health Care Group, Lahti, Finland.
authors.forename: N
authors.initials: N
authors.lastname: Neittaanmäki-Perttu
authors.forename: T T
authors.initials: TT
authors.lastname: Karppinen
authors.forename: M
authors.initials: M
authors.lastname: Grönroos
authors.forename: T T
authors.initials: TT
authors.lastname: Tani
authors.forename: E
authors.initials: E
authors.lastname: Snellman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D010778:Photochemotherapy / 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: C570703:BF-200 ALA; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid