Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo
Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo
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DOI：
10.1111/j.1365-2133.2011.10613.x
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发表时间：
2012-01-01
影响因子：
10.3
通讯作者：
Szeimies, R. -M.
中科院分区：
文献类型：
--
作者：
Dirschka, T.;Radny, P.;Szeimies, R. -M.
背景使用5-氨基乙酰丙酸（ALA）或其甲酯[5-氨基乙酰丙酸甲酯（MAL）或5-氨基-4-氧代戊酸酯]的光动力疗法（PDT）最近被列为治疗光化性角化病（AK）的一线疗法，并且是治疗肿瘤性皮肤病的可接受的治疗选择。BF-200 ALA（Biofrontera Bioscience GmbH，Leverkusen，德国）是ALA与纳米乳剂的凝胶制剂，用于治疗AK，其克服了先前ALA不稳定的问题并改善皮肤渗透性。一项安慰剂对照的个体间试验，BF-200 ALA是一种注册的MAL乳膏，安慰剂的比例为3：3：1。在德国、奥地利和瑞士的26个研究中心招募了600名患者，每名患者在面部和/或秃顶头皮上有4至8处轻度至中度AK病变。患者接受一次PDT治疗。结果BF-200 ALA PDT治疗后3个月患者病灶完全清除率（78.2%vs.17.1%，P < 0.0001）和病灶完全清除率（90.4%vs.37.1%）均优于安慰剂PDT（上级）。此外，在主要终点患者完全清除率方面，显示优于MAL乳膏（78.2% vs. 64.2%; P < 0.05）。患者和病变完全清除率和治疗相关的不良事件的严重程度显着差异进行了观察的窄谱和广谱lightsources.Conclusions BF-200 ALA是一个非常有效的，耐受性良好的新配方AK治疗PDT和上级注册的MAL药物。疗效和不良事件随所用光源的不同而变化很大。
Background Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration.Objectives To evaluate the efficacy and safety of PDT of AKs with BF-200 ALA in comparison with a registered MAL cream and with placebo.Methods The study was performed as a randomized, multicentre, observer-blind, placebo-controlled, interindividual trial with BF-200 ALA, a registered MAL cream and placebo in a ratio of 3 : 3 : 1. Six hundred patients, each with four to eight mild to moderate AK lesions on the face and/or the bald scalp, were enrolled in 26 study centres in Germany, Austria and Switzerland. Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated.Results PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (78.2% vs. 17.1%; P < 0.0001) and lesion complete clearance rate (90.4% vs. 37.1%) at 3 months after the last PDT. Moreover, superiority was demonstrated over the MAL cream regarding the primary endpoint patient complete clearance (78.2% vs. 64.2%; P < 0.05). Significant differences in the patient and lesion complete clearance rates and severity of treatment-related adverse events were observed for the narrow- and broad-spectrum light sources.Conclusions BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used.