Effective photodynamic therapy of actinic keratoses on the head and face with a novel, self-adhesive 5-aminolaevulinic acid patch

Hauschild, Axel and Popp, Georg and Stockfleth, Eggert and Meyer, Karl-Gustav and Imberger, Dirk and Mohr, Peter and Itschert, Gotz and Kaufmann, Roland and Neuber, Karsten and Frambach, Yvonne and Gollnick, Harald and Brunnert, Marcus and Stocker, Marcus and Ortland, Christoph and Karrer, Sigrid (2009) Effective photodynamic therapy of actinic keratoses on the head and face with a novel, self-adhesive 5-aminolaevulinic acid patch. EXPERIMENTAL DERMATOLOGY, 18 (2). pp. 116-121. ISSN 0906-6705,

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Abstract

Photodynamic therapy (PDT) is increasingly used for the treatment of actinic keratosis (AK). To investigate both the efficacy of different application times and the safety of a novel patch (PD P 506 A) containing aminolaevulinic acid in the PDT of mild to moderate AK. Applications of PD P 506 A for 0.5, 1, 2 and 4 h were compared in a multicentre, randomized, blinded-observer, parallel-group study. After patch removal, study lesions were illuminated with red light (lambda(em) approximate to 630 nm; 37 J/cm(2)). Study lesions were not pretreated (e.g. by curettage) prior to PDT. Efficacy was evaluated 4 and 8 weeks after treatment. Safety and tolerability were determined through laboratory analyses and documentation of both local reactions and adverse events. A total of 149 patients were initially enrolled. Of these, 140 patients (520 lesions) completed the study according to protocol. Eight weeks after treatment, 86% of the AK lesions (74% of the patients) treated with 4-h patch application showed complete clearance. The complete clearance rates of lesions (patients) for the 2-, 1- and 0.5-h treatment arms were 73% (47%), 72% (50%) and 51% (24%), respectively. Statistically, the 4-h application was identified as the 'best treatment'. Patients with clearance seemed to experience local reactions to a greater extent than patients without clearance. Local reactions to study treatments did not exceed the expected range. The results of this first clinical efficacy study suggest excellent therapeutic outcomes with a single PD P 506 A PDT with a 4-h application.

Item Type: Article
Uncontrolled Keywords: TOPICAL METHYL AMINOLEVULINATE; RANDOMIZED MULTICENTER; CELL CARCINOMA; SKIN-CANCER; CRYOTHERAPY; LIGHT; DERMATOLOGY; GUIDELINES; actinic keratosis; aminolaevulinic acid; clinical trial; photodynamic therapy
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Dermatologie und Venerologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 07 Oct 2020 04:54
Last Modified: 07 Oct 2020 04:54
URI: https://pred.uni-regensburg.de/id/eprint/29509

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