Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study

Summary 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 nanoemuls...

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Bibliographic Details
Published in:British journal of dermatology (1951) 2010-08, Vol.163 (2), p.386-394
Main Authors: 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., Reinhold, U.
Format: Article
Language:English
Subjects:
actinic keratosis
Adolescent
Adult
Aged
Aged, 80 and over
aminolaevulinic acid
Aminolevulinic Acid - therapeutic use
Biological and medical sciences
Biopsy
Dermatology
Double-Blind Method
Female
Germany
Humans
Keratosis, Actinic - drug therapy
Keratosis, Actinic - pathology
Male
Medical sciences
Middle Aged
multicentre trial
phase III
Photochemotherapy - methods
photodynamic therapy
Photosensitizing Agents - therapeutic use
Prospective Studies
randomized controlled trial
Young Adult
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Summary:Summary 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 
ISSN:0007-0963
1365-2133
DOI:10.1111/j.1365-2133.2010.09873.x