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临床试验/NCT07848100
NCT07848100尚未招募3 期

Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts

Assiut University0 个研究点目标入组 76 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
76
主要终点
Clinical Response of the Injected Warts

研究概览

简要总结

This clinical trial aims to compare the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of plantar warts.

详细描述

Viral warts represent benign epidermal proliferations associated with human papillomavirus (HPV) infection. HPV is a double-stranded DNA virus with more than 150 identified types, several of which have a predilection for cutaneous tissues and can produce distinct clinical forms of warts. Transmission occurs through direct skin-to-skin contact, indirect contact with contaminated surfaces, or autoinoculation, as when a wart is scratched or picked and virus is carried to a new site.

Cutaneous warts occur worldwide, with an estimated overall population prevalence of roughly 10%, rising to 10-20% among school-aged children. Although warts may develop at any age, incidence climbs through childhood and peaks between 12 and 16 years. Most lesions are asymptomatic, but they are not without consequence: warts can produce cosmetic disfigurement and psychosocial distress, and those on weight-bearing surfaces such as the plantar skin can become painful with walking or pressure. The principal clinical types are common, plantar, plane, filiform, and genital warts.

Plantar warts, the focus of the present study, arise on the sole and are most commonly attributed to HPV types 1, 2, 4, 27 and 57. Because of the constant pressure exerted by weight-bearing, these lesions tend to grow inward rather than outward and are often covered by a thick overlying callus that can mask the lesion and delay diagnosis; adjacent warts may also coalesce into a mosaic pattern. Unlike many other cutaneous warts, plantar warts are frequently symptomatic, producing a sharp, well-localized pain on walking or standing that can meaningfully impair mobility and daily activities. Clinically, they are distinguished from corns and calluses by the presence of pinpoint black dots, corresponding to thrombosed dermal capillaries, and by interruption of the normal skin lines across the lesion.

Several therapeutic modalities are available for cutaneous warts, including destructive methods such as salicylic acid, cryotherapy, silver nitrate, electrosurgery and pulsed-dye laser, antiproliferative agents such as formaldehyde, vitamin D3, bleomycin, 5-fluorouracil, podophyllin and podophyllotoxin, topical immunological agents such as imiquimod ; However, treatment remains challenging because of variable efficacy, prolonged treatment courses, recurrence and adverse effects. No single treatment option is considered gold standard.

Intralesional therapies are an emerging and effective approach for treating recalcitrant warts. Several immunotherapeutic agents for warts including vitamin D3; tuberculin purified protein derivative (PPD); Candida antigen (Candida); the measles, mumps, rubella (MMR) vaccine, BCG, zinc sulphate and antivirals such as acyclovir have demonstrated variable complete response rates in randomized controlled trials. Unlike various other treatment options, immunotherapeutic approaches upregulate the immune system to recognize and destroy the lesions at both the target site and distant locations.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
单盲 (受试者)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • Patients aged 18-50 years of both sexes clinically diagnosed with multiple plantar warts.

排除标准

  • Patients with wart types other than plantar warts (genital, common, and plane warts).
  • Pregnant or lactating women.
  • Immunocompromised patients.
  • Individuals receiving systemic immunosuppressive or antiviral therapy.
  • History of hypersensitivity to acyclovir or zinc compounds.
  • Patients with current acute febrile illness or any bacterial infection.
  • Receiving any treatment for warts within 1 month before the study.
  • Concurrent other skin disorders.
  • Patients with systemic diseases (liver or renal disease, bleeding disorders).

研究组 & 干预措施

Intralesional Zinc Sulphate

Active Comparator

This group will receive intralesional zinc sulphate 2%

干预措施: Intralesional Zinc Sulphate (Drug)

Intralesional Acyclovir

Active Comparator

This group will receive intralesional acyclovir

干预措施: Intralesional Acyclovir (Drug)

结局指标

主要结局

Clinical Response of the Injected Warts

时间窗: 8 weeks

Clinical response assessed by standardized digital photographs and dermoscopic evaluation. Response will be graded using scoring system : Score 0: neither clinical nor dermoscopic response. Score 1: clinical improvement without dermoscopic clearance. Score 2: clinical disappearance with dermoscopic evidence of residual wart tissue. Score 3: complete clinical and dermoscopic clearance with return of normal skin markings.

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Silvana Saeed Shawky

Resident, Department of Dermatology

Assiut University

标识符

NCT 编号
NCT07848100
其他研究编号
PlantarWarts-RCT-2026

日期

首次提交
(12天前)
首次发布
(昨天)
主要完成日期
(明年)
研究完成日期
(明年)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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