Conflicts of interest R.-M.S. and T.D. are consultants of the sponsoring company. G.P. and D.V. are employees of the company that was responsible for data management and statistical analysis. M.F., R.G. and H.L. are employees of the sponsoring company.
Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study
Article first published online: 28 MAY 2010
© 2010 Biofrontera Bioscience GmbH. Journal Compilation © 2010 British Association of Dermatologists
British Journal of Dermatology
Volume 163, Issue 2, pages 386–394, August 2010
How to Cite
Szeimies, R.-M., Radny, P., Sebastian, M., Borrosch, F., Dirschka, T., Krähn-Senftleben, G., Reich, K., Pabst, G., Voss, D., Foguet, M., Gahlmann, R., Lübbert, H. and Reinhold, U. (2010), Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. British Journal of Dermatology, 163: 386–394. doi: 10.1111/j.1365-2133.2010.09873.x
- Issue published online: 21 JUL 2010
- Article first published online: 28 MAY 2010
- Accepted for publication 17 May 2010
- actinic keratosis;
- aminolaevulinic acid;
- multicentre trial;
- phase III;
- photodynamic therapy;
- randomized controlled trial
Background Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) provides a therapeutic option for the treatment of actinic keratosis (AK). Different strategies are applied to overcome the chemical instability of ALA in solution and to improve skin penetration. A new stable nanoemulsion-based ALA formulation, BF-200 ALA, is currently in clinical development for PDT of AK.
Objectives To evaluate the efficacy and safety of PDT of AK with BF-200 ALA.
Methods The study was performed as a randomized, multicentre, double-blind, placebo-controlled, interindividual, two-armed trial with BF-200 ALA and placebo. A total of 122 patients with four to eight mild to moderate AK lesions on the face and/or the bald scalp were included in eight German study centres. The efficacy of BF-200 ALA after one and two PDT treatments was evaluated. BF-200 ALA was used in combination with two different light sources under illumination conditions defined by European competent authorities.
Results PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (per-protocol group: 64% vs. 11%; P < 0·0001) and lesion complete clearance rate (per-protocol group: 81% vs. 22%) after the last PDT treatment. Statistically significant differences in the patient and lesion complete clearance rates and adverse effect profiles were observed for the two light sources, Aktilite® CL128 and PhotoDyn® 750, at both time points of assessment. The patient and lesion complete clearance rates after illumination with the Aktilite® CL128 were 96% and 99%, respectively.
Conclusions BF-200 ALA is a very effective new formulation for the treatment of AK with PDT. Marked differences between the efficacies and adverse effects were observed for the different light sources used. Thus, PDT efficacy is dependent both on the drug and on the characteristics of the light source and the illumination conditions used.