J Drugs Dermatol. 2020 May 1;19(5):452-458.
The relationship between actinic keratoses (AKs) and nonmelanoma skin cancers (NMSCs) is well established. Patients with field cancerization are at high risk of developing new lesions. A treatment to interrupt new lesion formation or progression is required.
To evaluate occurrence of AKs in high-risk patients after field aminolevulinic acid–photodynamic therapy (ALA–PDT).
In this randomized, parallel-group, evaluator-blinded, 52-week study, patients with 4–15 facial AKs (N = 166) were random-ized (ALA 2x vs ALA 3x vs vehicle [VEH]-pooled [VEH 2x+VEH 3x], 1:1:1) to receive 2 or 3 PDT treatments (1-hour incubation) following cryotherapy at screening.
More ALA-treated patients than VEH-treated patients had no AKs at week 52 (ALA 2x, 36.0%, P=0.0102; ALA 3x, 37.5%, P=0.0089; VEH, 18.9%). Week 52 lesion recurrence rates were 7.7% (P=0.0004) and 6.1% (P<0.0001) for ALA 2x and ALA 3x, respec-tively, versus 15.5% for VEH. Therapy was well tolerated; no patient requested early termination of light treatment. ALA 3x reduced NMSC development versus VEH (5 vs 12 lesions, P=0.0014).
2 or 3 ALA–PDT treatments with 1-hour incubation can significantly reduce occurrence of AKs after 1 year in patients at high risk of NMSC versus VEH–PDT (NCT02239679). J Drugs Dermatol. 2020;19(5):452-458. doi:10.36849/JDD.2020.4930.
光化性角化病（AK）与非黑素瘤皮肤癌（NMSC）之间的关系已得到充分证实。存在区域性癌变的患者发生新病变的风险很高。需要一种能够阻止新病变形成或进展的治疗方法。
评估高风险患者在接受局部氨基酮戊酸-光动力疗法（ALA-PDT）治疗后 AK 的发生情况。
在这项随机、平行组、评估者设盲、52 周的研究中，将 166 例 4-15 处面部 AK 患者（N=166）随机分为 3 组（ALA 2 次与 ALA 3 次与安慰剂[VEH]- pooled[VEH 2 次+VEH 3 次]，1:1:1），在筛查时进行冷冻治疗后，接受 2 或 3 次 PDT 治疗（1 小时孵育）。
与 VEH 治疗组相比，接受 ALA 治疗的患者在第 52 周时 AK 无病变的比例更高（ALA 2 次，36.0%，P=0.0102；ALA 3 次，37.5%，P=0.0089；VEH，18.9%）。第 52 周时，ALA 2 次和 ALA 3 次的病变复发率分别为 7.7%（P=0.0004）和 6.1%（P<0.0001），而 VEH 为 15.5%。治疗耐受性良好；无患者要求提前终止光照治疗。与 VEH 相比，ALA 3 次治疗可降低 NMSC 发生风险（5 例与 12 例病变，P=0.0014）。
与 VEH-PDT 相比，高危 NMSC 患者在 1 年内接受 2 或 3 次 ALA-PDT 治疗（1 小时孵育）可显著降低 AK 的发生（NCT02239679）。J 皮肤病药物杂志。2020；19（5）：452-458。doi：10.36849/JDD.2020.4930。
