Antaya Richard J., del Carmen Maria, Alonso Fraile, Sukumar Nitin, Yong Fang, Dvoretzky Israel
J Drugs Dermatol. 2019 Apr 1;18(4):368-373.
Background: Local hyperthermia has been demonstrated to be a safe and efficacious treatment for warts. Objective: We aimed to evaluate the safety and efficacy of an epicutaneous heat patch to induce local hyperthermia for the treatment of warts. Methods: We performed an uncontrolled, proof of concept study by applying a novel, reproducible, epicutaneous heat patch to a target wart for 2 hours per day for 12 weeks. There were 15 evaluable participants. An untreated wart was also observed and measured. Wart measurements included the diameter in two dimensions, an investigator global assessment (IGA) score, wart clearance, and monitoring for adverse events as endpoints at week 12 (end of treatment) and week 24 (end of study). Results: No major adverse events were observed. 6.7% of participants reported minor cutaneous events. At week 24, 46.7% of participants achieved complete clearance of both warts. Limitations: The small sample size and lack of independent control in each participant were the main limiting factors. Conclusion: Local hyperthermia delivered by epicutaneous heat patches was well-tolerated, safe, and achieved complete clearance in both treated as well untreated warts in 46.7% of participants at week 24 after 12 weeks of daily use. Clinicaltrials.gov: NCT01746056 J Drugs Dermatol. 2019;18(4):368-373.
局部热疗已被证明是一种治疗疣的安全有效的方法。目的:我们旨在评估一种表皮热贴诱导局部热疗治疗疣的安全性和有效性。方法:我们进行了一项非对照的概念验证研究,通过每天将一种新型、可重复的表皮热贴应用于目标疣2小时,持续12周。有15名可评估的参与者。还观察和测量了一个未治疗的疣。疣的测量包括两个维度的直径、研究者整体评估(IGA)评分、疣清除情况以及监测不良事件,以第12周(治疗结束)和第24周(研究结束)作为终点。结果:未观察到重大不良事件。有6.7%的参与者报告了轻微的皮肤事件。在第24周时,46.7%的参与者实现了两个疣的完全清除。局限性:样本量小以及每个参与者缺乏独立对照是主要限制因素。结论:在每天使用12周后,第24周时,表皮热贴进行的局部热疗耐受性良好、安全,并且46.7%的参与者在治疗和未治疗的疣中均实现了完全清除。Clinicaltrials.gov:NCT01746056 《皮肤药物学杂志》。2019年;18(4):368 - 373。