Smith Stacy R, Xu Shuai, Estes Esther, Shanler Stuart D
J Drugs Dermatol. 2018 Oct 1;17(10):1092-1098.
Seborrheic keratoses (SKs) may present in any non-glabrous skin, but data are limited on the response to treatment as based on the SK location. We aimed to understand the relationship between SK location and clearance with up to 2 treatments of 40% (w/w) hydrogen peroxide topical solution (HP40).
We conducted a sub-analysis of data pooled from two randomized, double-blind, vehicle (VEH)-controlled clinical trials, including 937 patients, each with 4 target SKs (N=3,748 SKs), with at least 1 on the face and 1 on the trunk or extremities. Treatment response was defined as 0 or 1 on a 4-point Physician's Lesion Assessment (PLA) scale (0=clear; 1=near-clear) after up to 2 applications, 3 weeks apart, and was assessed by SK location (face, trunk, and extremity). Local skin reactions were stratified by anatomic location and categorized based on immediate and delayed post-treatment reactions. Sensitivity analysis was conducted using the mean-per-patient (MPP) percent of SKs that are clear or near-clear at day 106.
Treatment response was greater with HP40 versus VEH regardless of anatomic location of the SK. Clear or near-clear SKs with HP40 was observed in 65% of facial SKs (vs 10% VEH), 46% of truncal SKs (vs 5% VEH), and 38% of extremity SKs (vs 9% VEH). Facial SKs were more likely to be clear or near clear after a single treatment (43%), versus SKs on the trunk (31%) or extremities (14%). Most common immediate reactions with HP40 were erythema, stinging, and edema, which resolved to none or mostly mild within a week. Delayed reactions such as dyspigmentation and scarring occurred at low rates and were least reported for the facial SKs.
SK clearance with HP40 was highest among SKs on the face and lowest among SKs on the extremities. Dyspigmentation rates were lowest among SKs treated on the face. Anatomic location of SK was a predictor of both treatment response and risk of dyspigmentation with HP40 application. ClinicalTrials.gov listings: NCT02667236 and NCT02667275 J Drugs Dermatol. 2018;17(10):1092-1098.
脂溢性角化病（SKs）可出现在任何非无毛皮肤上，但基于SK位置的治疗反应数据有限。我们旨在了解SK位置与使用高达2次40%（w/w）过氧化氢外用溶液（HP40）治疗后清除情况之间的关系。
我们对两项随机、双盲、赋形剂（VEH）对照临床试验汇总的数据进行了亚组分析，包括937名患者，每人有4个目标SK（N = 3748个SK），至少1个在面部，1个在躯干或四肢。治疗反应定义为在相隔3周的最多2次用药后，根据4分医生皮损评估（PLA）量表评分为0或1（0 = 清除；1 = 接近清除），并按SK位置（面部、躯干和四肢）进行评估。局部皮肤反应按解剖位置分层，并根据治疗后即时和延迟反应进行分类。使用第106天时每位患者清除或接近清除的SK的平均百分比（MPP）进行敏感性分析。
无论SK的解剖位置如何，HP40治疗反应均优于VEH。在65%的面部SK中观察到HP40治疗后SK清除或接近清除（VEH为10%），46%的躯干SK（VEH为5%），38%的四肢SK（VEH为9%）。单次治疗后，面部SK更有可能清除或接近清除（43%），而躯干（31%）或四肢（14%）的SK则不然。HP40最常见的即时反应是红斑、刺痛和水肿，在一周内消退至无或大多为轻度。色素沉着异常和瘢痕形成等延迟反应发生率较低，面部SK报告最少。
HP40治疗SK的清除率在面部SK中最高，在四肢SK中最低。面部治疗的SK色素沉着异常率最低。SK的解剖位置是HP40治疗反应和色素沉着异常风险的预测指标。ClinicalTrials.gov登记号：NCT02667236和NCT02667275《皮肤药物杂志》。2018；17（10）：1092 - 1098。
