title: Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis.
abstract: BACKGROUND
  Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates.
  
  
  OBJECTIVE
  To evaluate long-term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF-200 ALA, MAL or placebo.
  
  
  METHODS
  The follow-up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF-200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT.
  
  
  RESULTS
  Recurrence rates were similar for BF-200 ALA and MAL, with a tendency to lower recurrence rates for BF-200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF-200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF-200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported.
  
  
  CONCLUSIONS
  The FUP data confirmed the high efficacy and safety of PDT with BF-200 ALA. The slightly lower recurrence rates after BF-200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy.
authors.affiliation: Private Dermatological Practice Centre, Wuppertal, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Dirschka
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authors.lastname: Radny
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authors.initials: R
authors.lastname: Dominicus
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authors.lastname: Mensing
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authors.lastname: Brüning
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authors.lastname: Jenne
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authors.lastname: Karl
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authors.lastname: Sebastian
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authors.lastname: Oster-Schmidt
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authors.lastname: Klövekorn
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authors.lastname: Reinhold
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authors.lastname: Tanner
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authors.initials: D
authors.lastname: Gröne
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authors.lastname: Deichmann
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authors.lastname: Simon
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authors.initials: F
authors.lastname: Hübinger
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authors.lastname: Hofbauer
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authors.lastname: Krähn-Senftleben
authors.forename: F
authors.initials: F
authors.lastname: Borrosch
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authors.lastname: Reich
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authors.lastname: Berking
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authors.lastname: Wolf
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authors.initials: P
authors.lastname: Lehmann
authors.forename: M
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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: S
authors.initials: S
authors.lastname: Hahn
authors.forename: G
authors.initials: G
authors.lastname: Pabst
authors.forename: D
authors.initials: D
authors.lastname: Voss
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: D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: C570703:BF-200 ALA; D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid