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

T 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, T 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

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.

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.

© 2012 Biofrontera Bioscience GmbH BJD © 2012 British Association of Dermatologists.

Figures

Fig. 1
Fig. 1
Treatment regimen of the clinical phases and follow-up (FU) phases of studies ALA-AK-CT002 and ALA-AK-CT003. Assessment of photodynamic therapy (PDT) efficacy was scheduled 3 months after PDT. Subsequently, completely cleared patients entered FUP with two visits 6 and 12 months after PDT (a). In case of residual lesions 3 months after the first PDT, a second PDT was performed (b) with a final assessment of efficacy 3 months later. MAL, methyl aminolaevulinate.
Fig. 2
Fig. 2
Allocation of patients in the follow-up phases (FUPs) of studies ALA-AK-CT003 (a) and ALA-AK-CT002 (b). The numbers of patients entering and completing FUP are indicated along with the cause of discontinuation during the FUP. CRP, complete responders, i.e. patients without remaining lesions 3 months after the last treatment with photodynamic therapy; MAL, methyl aminolaevulinate; SAE, serious adverse event.

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Source: PubMed

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