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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.

AbstractBACKGROUND:
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.
OBJECTIVES:
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.
AuthorsT Dirschka, P Radny, R Dominicus, H Mensing, H Brüning, L Jenne, L Karl, M Sebastian, C Oster-Schmidt, W Klövekorn, U Reinhold, M Tanner, D Gröne, M Deichmann, M Simon, F Hübinger, G Hofbauer, G Krähn-Senftleben, F Borrosch, K Reich, C Berking, P Wolf, P Lehmann, M Moers-Carpi, H Hönigsmann, K Wernicke-Panten, S Hahn, G Pabst, D Voss, M Foguet, B Schmitz, H Lübbert, R-M Szeimies, AK-CT002 Study Group, AK-CT003 Study Group
JournalThe British journal of dermatology (Br J Dermatol) Vol. 168 Issue 4 Pg. 825-36 (Apr 2013) ISSN: 1365-2133 [Electronic] England
PMID23252768 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2012 Biofrontera Bioscience GmbH BJD © 2012 British Association of Dermatologists.
Chemical References
  • BF-200 ALA
  • Photosensitizing Agents
  • methyl 5-aminolevulinate
  • Aminolevulinic Acid
Topics
  • Aged
  • Aged, 80 and over
  • Aminolevulinic Acid (administration & dosage, adverse effects, analogs & derivatives)
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Keratosis, Actinic (drug therapy)
  • Long-Term Care
  • Male
  • Middle Aged
  • Photochemotherapy (methods)
  • Photosensitizing Agents (administration & dosage, adverse effects)
  • Prospective Studies
  • Recurrence
  • Treatment Outcome

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