Nowarta110 外用治疗跖疣的主题对照安慰剂:一项Ⅰ/Ⅱ期随机对照临床试验。
Nowarta110 Topical Versus Placebo for the Treatment of Plantar Warts: A Phase I/II Randomized Controlled Clinical Trial.
发表日期:2023 May
作者:
Mahkameh Yousefpour, Iraj Zamanian, Ferre Akbarpour, William H Fang, B O Han, Ba X Hoang
来源:
Immunity & Ageing
摘要:
植物疣是由人乳头瘤病毒(HPV)感染角质细胞在足底形成的皮肤病变。疣的严重程度和范围不同,但会影响各个年龄组的病患者,带来疼痛和不适。治疗植物疣一直是一项具有挑战性的任务。该研究目的在于比较天然来源Nowarta110局部配方与安慰剂对照治疗植物疣的疗效和安全性。该研究为随机、双盲、平行分配对照干预I/II临床试验。研究纳入54例植物疣患者,随机分为两组:安慰剂组包括26名接受安慰剂治疗的患者,Nowarta110组包括28名接受Nowarta110治疗的患者。通过临床检查诊断植物疣。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。Nowata110组中,18名患者(64.3%)的疣完全消失,10名患者(35.7%)对治疗部分反应,疣的大小降低20%至80%。在安慰剂组中,只有2名患者(7.7%)的疣完全消失,3名患者(11.5%)对治疗部分反应,疣的大小降低10%至35%。两组之间的差异极为显著。Nowarta110组有1例轻微疼痛作为副作用,安慰剂组有9例非严重局部副作用,其中包括2名退出治疗的患者。局部Nowarta110是治疗顽固和复发性植物疣的一种安全、耐受性好、疗效显著的治疗方法。该研究的突破性发现鼓励进一步开展广泛的临床试验,以充分探索Nowarta110在治疗各类型疣和与HPV相关疾病方面的前景。版权所有©2023国际抗癌研究所(George J. Delinasios博士)。
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.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.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.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.Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.