Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands.
摘要：
背景：手突光化性角化病（AK）病变被认为难以治疗，关于这些病变的光动力疗法（PDT）的公开数据有限。因此，我们评估了持续的疗效，安全,PDT后对手上的AK的满意度。
方法：我们分析了随机分组的手部治疗数据，双盲,个体内部III期研究。所有参与者先前都经历了多达两个具有10％5-氨基乙酰丙酸纳米乳液凝胶（BF-200ALA）的场定向红光PDT。评估包括PDT期间的疼痛，清除率和复发率，和满意度。
结果：包括24名在手上治疗的参与者；分析了21名参与者。BF-200ALA的完全清除率为90.9%（基于病变）和76.2%（每个参与者侧），两者都明显高于车辆。BF-200ALA的病灶复发率为29.0%。不良事件反映了行动模式。在11分数字评定量表上，平均疼痛强度为4.8±3.8（BF-200ALA）和0.8±2.1（媒介物）。大多数参与者（81.0%）对BF-200ALA的满意度评价为非常好或良好。
结论：此亚组分析表明，使用BF-200ALA的PDT为手部AK病变提供了合适的治疗方法。
方法：我们分析了随机分组的手部治疗数据，双盲,个体内部III期研究。所有参与者先前都经历了多达两个具有10％5-氨基乙酰丙酸纳米乳液凝胶（BF-200ALA）的场定向红光PDT。评估包括PDT期间的疼痛，清除率和复发率，和满意度。
结果：包括24名在手上治疗的参与者；分析了21名参与者。BF-200ALA的完全清除率为90.9%（基于病变）和76.2%（每个参与者侧），两者都明显高于车辆。BF-200ALA的病灶复发率为29.0%。不良事件反映了行动模式。在11分数字评定量表上，平均疼痛强度为4.8±3.8（BF-200ALA）和0.8±2.1（媒介物）。大多数参与者（81.0%）对BF-200ALA的满意度评价为非常好或良好。
结论：此亚组分析表明，使用BF-200ALA的PDT为手部AK病变提供了合适的治疗方法。
