title: A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz(®) ) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED(®) lamp.
abstract: BACKGROUND
  Multiple actinic keratosis (AK) lesions may arise from the cancerization of large, sun-damaged skin areas. Although photodynamic therapy (PDT) is considered the most effective therapeutic option, the efficacy and safety of field treatment of multiple AK lesions with PDT has never before been tested in a pivotal trial.
  
  
  OBJECTIVE
  To evaluate the efficacy, safety and cosmetic outcome of BF-200 ALA (a nanoemulsion formulation containing 10% aminolaevulinic acid hydrochloride) combined with the BF-RhodoLED(®) lamp for the field-directed treatment of mild-to-moderate AK with PDT.
  
  
  METHODS
  The study was performed as a randomized, multicentre, double-blind, placebo-controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were enrolled in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED (635 nm ± 9 nm) until a total light dose of 37 J cm(-2) was achieved.
  
  
  RESULTS
  BF-200 ALA was superior to placebo with respect to patient complete clearance rate (91% vs. 22%, P < 0·0001) and lesion complete clearance rate (94·3% vs. 32·9%, P < 0·0001) after a maximum of two PDTs. The confirmatory analysis of all key secondary variables supported this superiority" should not be skipped since this is an important result. Treatment-emergent adverse events (TEAEs) were experienced by 100% of the BF-200 ALA group and 69% of the placebo group. The most commonly reported TEAEs were TEAEs of the application site. The cosmetic outcome was improved in the BF-200 ALA group compared with placebo.
  
  
  CONCLUSIONS
  Field-directed therapy with BF-200 ALA and BF-RhodoLED lamp is highly effective and well tolerated for multiple mild-to-moderate AK lesions, providing greatly improved skin quality.
authors.affiliation: Dermatological Center Bonn Friedensplatz, Bonn, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Reinhold
authors.affiliation: Private Practice, Wuppertal-Barmen, Germany.|Faculty of Health, University Witten/Herdecke, Witten, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Dirschka
authors.affiliation: Private Practice, Mönchengladbach, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Ostendorf
authors.affiliation: Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Aschoff
authors.affiliation: Department of Dermatology and Allergology, University Hospital, Munich, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Berking
authors.affiliation: Medical Centre Cologne, Cologne, Germany.
authors.forename: W G
authors.initials: WG
authors.lastname: Philipp-Dormston
authors.affiliation: Accovion GmbH, Eschborn, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Hahn
authors.affiliation: Accovion GmbH, Eschborn, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Lau
authors.affiliation: Biofrontera Bioscience GmbH, Leverkusen, Germany. a.jaeger@biofrontera.com.
authors.forename: A
authors.initials: A
authors.lastname: Jäger
authors.affiliation: Biofrontera Bioscience GmbH, Leverkusen, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Schmitz
authors.affiliation: Biofrontera Bioscience GmbH, Leverkusen, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Lübbert
authors.affiliation: Department of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany.
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*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010778:Photochemotherapy / Q000295:instrumentation / 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; D000622:Aminolevulinic Acid