CMB Collegium Medicum Berlin GmbH, Berlin, Germany.
MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany.
Photodiagnosis Photodyn Ther. 2024 Oct;49:104280. doi: 10.1016/j.pdpdt.2024.104280. Epub 2024 Jul 11.
Acral actinic keratosis (AK) lesions are considered difficult to treat, and published data for photodynamic therapy (PDT) on these lesions is limited. Thus, we evaluated sustained efficacy, safety, and satisfaction after PDT for AK on the hands.
We analysed subgroup data for treatment on the hands from a randomised, double-blind, intra-individual phase III study. All participants previously underwent up to two field-directed red light PDTs with 10 % 5-aminolevulinic acid nanoemulsion gel (BF-200 ALA). Assessments included pain during PDT, clearance and recurrence rates, and satisfaction.
24 participants treated on the hands were included; 21 participants were analysed. Complete clearance rates with BF-200 ALA were 90.9 % (lesion-based) and 76.2 % (per participant's side), both markedly higher than with vehicle. The lesion recurrence rate with BF-200 ALA was 29.0 %. Adverse events reflected the mode of action. Mean pain intensities were 4.8 ± 3.8 (BF-200 ALA) and 0.8 ± 2.1 (vehicle) on an 11-point numeric rating scale. Most participants (81.0 %) rated their satisfaction with BF-200 ALA as very good or good.
This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands.
肢端光化性角化病（AK）皮损被认为难以治疗，且目前有关这些皮损光动力疗法（PDT）的发表数据有限。因此，我们评估了 PDT 治疗手部 AK 的持续疗效、安全性和满意度。
我们分析了一项随机、双盲、个体内 III 期研究中手部治疗的亚组数据。所有参与者先前都接受过最多两次针对病灶的红光 PDT 治疗，所用 PDT 药物为 10% 5-氨基酮戊酸纳米乳凝胶（BF-200 ALA）。评估包括 PDT 期间的疼痛、清除率和复发率以及满意度。
24 名手部接受治疗的参与者被纳入研究，其中 21 名参与者纳入分析。BF-200 ALA 的完全清除率为 90.9%（基于皮损）和 76.2%（按每位参与者的侧别），均显著高于载体组。BF-200 ALA 的皮损复发率为 29.0%。不良事件反映了作用模式。基于 11 分数字评分量表，BF-200 ALA 的平均疼痛强度为 4.8±3.8，载体组为 0.8±2.1。大多数参与者（81.0%）对 BF-200 ALA 的满意度评价为很好或好。
这项亚组分析表明，BF-200 ALA 的 PDT 为手部 AK 皮损提供了一种合适的治疗方法。
