DuBois Janet, Grande Kimberly, Rhodes Thomas, Schnyder Judith, Shanler Stuart D
J Drugs Dermatol. 2020 Dec 1;19(12):1184-1191. doi: 10.36849/JDD.2020.4974.
Assess participants’ satisfaction following treatment with a proprietary hydrogen peroxide topical solution 40%, w/w (HP40) for raised seborrheic keratoses (SKs).
In this Phase 4, open-label study, eligible participants aged 30–75 years had clinically typical raised SKs including 2 target SKs (Physician’s Lesion Assessment™ [PLA] grade of ≥2 [0 = clear; 1 = near clear; 2 = thin (≤1 mm); 3 = thick (>1 mm)]; 5–15 mm diameter) on the face and 1 target SK on the neck or décolletage. SKs received HP40 treatment on day 1. All SKs with PLA grade ≥1 were retreated on days 15 and 29. Endpoints included patients’ satisfaction with their skin’s appearance at day 113, relationships between patients’ satisfaction and lesion PLA grade (evaluated by chi-square test), and patients’ satisfaction with their treatment experience.
Forty-one patients (mean [range] age, 62.4 [46–73] years) completed the study. 95% of patients were at least moderately satisfied with their skin’s appearance and 90.2% of target lesions were clear. A statistically significant association was observed between the number of target lesions achieving clearance and patients’ satisfaction with skin appearance level (χ2=22.03; P=0.001). 93% of patients were at least moderately satisfied with their HP40 treatment experience. Eight patients experienced treatment-emergent adverse events (TEAEs), most of which were mild or moderate; 4 experienced TEAEs considered treatment-related.
Most patients with SKs on the face, neck, and décolletage were satisfied or very satisfied with both their skin’s appearance and their treatment experience following HP40 treatment. These results support the use of HP40 for raised SKs. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.4974.
评估使用一种专利的40%（重量/重量）过氧化氢外用溶液（HP40）治疗隆起性脂溢性角化病（SKs）后参与者的满意度。
在这项4期开放标签研究中，年龄在30至75岁的符合条件的参与者患有临床典型的隆起性SKs，包括面部有2个目标SKs（医生病变评估[PLA]等级≥2[0 = 清除；1 = 接近清除；2 = 薄（≤1毫米）；3 = 厚（>1毫米）]；直径5至15毫米）以及颈部或胸部有1个目标SKs。SKs在第1天接受HP40治疗。所有PLA等级≥1的SKs在第15天和第29天再次接受治疗。终点包括患者在第113天对其皮肤外观的满意度、患者满意度与病变PLA等级之间的关系（通过卡方检验评估）以及患者对其治疗体验的满意度。
41名患者（平均[范围]年龄，62.4[46至73]岁）完成了研究。95%的患者对其皮肤外观至少中度满意，90.2%的目标病变清除。在实现清除的目标病变数量与患者对皮肤外观水平的满意度之间观察到统计学上的显著关联（χ2 = 22.03；P = 0.001）。93%的患者对其HP40治疗体验至少中度满意。8名患者经历了治疗中出现的不良事件（TEAEs），其中大多数为轻度或中度；4名患者经历了被认为与治疗相关的TEAEs。
大多数面部、颈部和胸部患有SKs的患者对HP40治疗后的皮肤外观和治疗体验感到满意或非常满意。这些结果支持将HP40用于隆起性SKs。《药物皮肤病学杂志》。2020年；19(12)：doi:10.36849/JDD.2020.4974。
