title: Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo.
abstract: BACKGROUND
  Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of PDT of AKs with BF-200 ALA in comparison with a registered MAL cream and with placebo.
  
  
  METHODS
  The study was performed as a randomized, multicentre, observer-blind, placebo-controlled, interindividual trial with BF-200 ALA, a registered MAL cream and placebo in a ratio of 3:3:1. Six hundred patients, each with four to eight mild to moderate AK lesions on the face and/or the bald scalp, were enrolled in 26 study centres in Germany, Austria and Switzerland. Patients received one PDT. If residual lesions remained at 3months after treatment, PDT was repeated.
  
  
  RESULTS
  PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (78·2% vs. 17·1%; P<0·0001) and lesion complete clearance rate (90·4% vs. 37·1%) at 3months after the last PDT. Moreover, superiority was demonstrated over the MAL cream regarding the primary endpoint patient complete clearance (78·2% vs. 64·2%; P<0·05). Significant differences in the patient and lesion complete clearance rates and severity of treatment-related adverse events were observed for the narrow- and broad-spectrum light sources.
  
  
  CONCLUSIONS
  BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used.
authors.affiliation: Private Dermatological Practice Centre, Wuppertal, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Dirschka
authors.forename: P
authors.initials: P
authors.lastname: Radny
authors.forename: R
authors.initials: R
authors.lastname: Dominicus
authors.forename: H
authors.initials: H
authors.lastname: Mensing
authors.forename: H
authors.initials: H
authors.lastname: Brüning
authors.forename: L
authors.initials: L
authors.lastname: Jenne
authors.forename: L
authors.initials: L
authors.lastname: Karl
authors.forename: M
authors.initials: M
authors.lastname: Sebastian
authors.forename: C
authors.initials: C
authors.lastname: Oster-Schmidt
authors.forename: W
authors.initials: W
authors.lastname: Klövekorn
authors.forename: U
authors.initials: U
authors.lastname: Reinhold
authors.forename: M
authors.initials: M
authors.lastname: Tanner
authors.forename: D
authors.initials: D
authors.lastname: Gröne
authors.forename: M
authors.initials: M
authors.lastname: Deichmann
authors.forename: M
authors.initials: M
authors.lastname: Simon
authors.forename: F
authors.initials: F
authors.lastname: Hübinger
authors.forename: G
authors.initials: G
authors.lastname: Hofbauer
authors.forename: G
authors.initials: G
authors.lastname: Krähn-Senftleben
authors.forename: F
authors.initials: F
authors.lastname: Borrosch
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.forename: C
authors.initials: C
authors.lastname: Berking
authors.forename: P
authors.initials: P
authors.lastname: Wolf
authors.forename: P
authors.initials: P
authors.lastname: Lehmann
authors.forename: M
authors.initials: M
authors.lastname: Moers-Carpi
authors.forename: H
authors.initials: H
authors.lastname: Hönigsmann
authors.forename: K
authors.initials: K
authors.lastname: Wernicke-Panten
authors.forename: C
authors.initials: C
authors.lastname: Helwig
authors.forename: M
authors.initials: M
authors.lastname: Foguet
authors.forename: B
authors.initials: B
authors.lastname: Schmitz
authors.forename: H
authors.initials: H
authors.lastname: Lübbert
authors.forename: R-M
authors.initials: RM
authors.lastname: Szeimies
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C570703:BF-200 ALA; D005782:Gels; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid