Department of Dermatology, Regensburg University Hospital, Regensburg, Germany.
Br J Dermatol. 2010 Aug;163(2):386-94. doi: 10.1111/j.1365-2133.2010.09873.x. Epub 2010 May 28.
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.
To evaluate the efficacy and safety of PDT of AK with BF-200 ALA.
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.
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.
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.
5-氨基酮戊酸（ALA）的光动力疗法（PDT）为光化性角化病（AK）的治疗提供了一种治疗选择。不同的策略被应用于克服 ALA 在溶液中的化学不稳定性并提高皮肤穿透性。一种新的稳定的基于纳米乳液的 ALA 制剂 BF-200 ALA，目前正在临床开发中用于 AK 的 PDT。
评估 PDT 治疗 AK 时 BF-200 ALA 的疗效和安全性。
该研究是一项随机、多中心、双盲、安慰剂对照、个体间、双臂试验，采用 BF-200 ALA 和安慰剂。共有 122 名患者在 8 个德国研究中心参与了这项研究，他们的面部和/或光头有 4 到 8 个轻度至中度 AK 病变。评估了一次和两次 PDT 治疗后 BF-200 ALA 的疗效。BF-200 ALA 与两种不同的光源联合使用，在欧洲主管当局规定的光照条件下进行。
与安慰剂 PDT 相比，BF-200 ALA-PDT 在最后一次 PDT 治疗后的患者完全清除率（方案组：64% vs. 11%；P<0.0001）和病变完全清除率（方案组：81% vs. 22%）方面均具有优势。在两个评估时间点，两种光源 Aktilite CL128 和 PhotoDyn 750 的患者和病变完全清除率以及不良事件谱均观察到统计学显著差异。使用 Aktilite CL128 进行光照时，患者和病变的完全清除率分别为 96%和 99%。
BF-200 ALA 是一种非常有效的 AK 治疗 PDT 的新制剂。所使用的不同光源在疗效和不良反应方面存在明显差异。因此，PDT 疗效不仅取决于药物，还取决于光源的特性和所使用的光照条件。
