《Nowarta110 局部安慰剂治疗足底疣：一项 I/II 期随机对照临床试验》。

Nowarta110 Topical Placebo for the Treatment of Plantar Warts: A Phase I/II Randomized Controlled Clinical Trial.

机构信息

Orange County Foot Clinic, Fullerton, CA, U.S.A.

Palm View Medical, Irvine, CA, U.S.A.

出版信息

Anticancer Res. 2023 May;43(5):2025-2030. doi: 10.21873/anticanres.16363.

DOI:10.21873/anticanres.16363

PMID:37097670

Abstract

BACKGROUND/AIM: Plantar warts are cutaneous lesions on the plantar aspect of the foot caused by the infection of keratinocytes with the human papillomavirus (HPV). The severity and magnitude of warts can vary, but they cause pain and discomfort for all age groups. The treatment for plantar warts remains a continuing challenge. The purpose of this research was to compare the efficacy and safety of naturally derived Nowarta110 topical formula versus a matching placebo in treating plantar warts.

PATIENTS AND METHODS

The study is a randomized, double-blind, parallel assignment control interventional phase I/II clinical trial. This study included 54 patients with plantar warts. Patients were randomized to two groups: the placebo group, which included 26 patients treated with a matching placebo and the Nowarta110 group, which included 28 patients who received topical Nowarta110. The diagnosis of plantar warts was made by clinical examination. The treatment's efficacy and safety were assessed every week and after 6 weeks from the initiation of the intervention.

RESULTS

In the Nowata110 group, 18 patients (64.3%) were completely cleared of their warts, and 10 patients (35.7%) partially responded to the therapy with a 20% to 80% decrease in warts dimensions. In the placebo group, only 2 patients (7.7%) were completely cleared of their warts, and 3 patients (11.5%) partially responded to the intervention with a 10% to 35% decrease in warts dimensions. The difference was highly significant between the two groups. There was 1 event with minor pain as a side effect in the Nowarta110 group and 9 events of non-serious local side effects in the placebo group, which included 2 patients who dropped out.

CONCLUSION

Topical Nowarta110 is a safe, well-tolerated, and highly effective therapeutic modality in treating refractory and recurrent plantar warts. The breakthrough findings of the study encourage further extensive clinical trials to fully explore the prospect of Nowarta110 in managing all types of warts and HPV-related diseases.

摘要

背景/目的：足底疣是足底皮肤的角化细胞感染人乳头瘤病毒（HPV）引起的皮肤损伤。疣的严重程度和大小不一，但会引起所有年龄段的疼痛和不适。足底疣的治疗仍然是一个持续的挑战。本研究的目的是比较天然衍生的 Nowarta110 局部配方与匹配安慰剂在治疗足底疣方面的疗效和安全性。

患者和方法

该研究是一项随机、双盲、平行分配对照的 I/II 期临床试验。本研究纳入了 54 例足底疣患者。患者随机分为两组：安慰剂组 26 例患者接受匹配安慰剂治疗，Nowarta110 组 28 例患者接受局部 Nowarta110 治疗。通过临床检查诊断足底疣。治疗的疗效和安全性在干预开始后每周和 6 周后进行评估。

结果

在 Nowata110 组中，18 例患者（64.3%）完全清除了疣，10 例患者（35.7%）对治疗有部分反应，疣的大小减少了 20%至 80%。在安慰剂组中，只有 2 例患者（7.7%）完全清除了疣，3 例患者（11.5%）对干预有部分反应，疣的大小减少了 10%至 35%。两组之间的差异具有高度显著性。在 Nowarta110 组中有 1 例患者出现轻微疼痛的副作用事件，在安慰剂组中有 9 例患者出现非严重局部副作用事件，其中包括 2 例患者退出。