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临床试验/NCT05324904
NCT05324904Unknown不适用

Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts

Assiut University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
complete healing rate

研究概览

简要总结

To evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional vitamin D3 in the treatment of plantar warts

详细描述

Introduction Warts are common epidermal growths caused by various strains of human papillomavirus (HPV) affecting all age groups. They have an unsightly appearance and are mostly asymptomatic but sometimes may be painful as in the case of palmoplantar warts . Plantar warts is a clinical variant that occur on sole of the foot, most frequently over pressure points .

It is estimated that 40% of population is infected with HPV, and in 7% to 12%, a wart develops . Plantar warts exhibit an annual incidence of 14% in the general population . Sixty-five percent to 78% of cutaneous warts have been shown to regress within 2 years . In persons older than 12 years, the rate of spontaneous regression significantly decreases .

Variable therapeutic options are available for treating warts, with none considered a gold standard. Primary treatments include topical salicylic acid, topical imiquimod, topical 5-fluorouracil, cryotherapy, excision, electrocautry and laser vaporization .

Vitamin D is a fat-soluble steroid prohormone that has wide range of biological actions e.g. inhibition of cellular proliferation, induction of terminal differentiation, and inhibition of angiogenesis. It also stimulates macrophages and cathelicidin production . Recently, several studies have demonstrated the efficacy of intralesional vitamin D in treatment of warts, as well as recalcitrant lesions, with clearance rates of 72.5%-90% .

Acyclovir is a synthetic purine nucleoside analogue with activity against some viruses as herpes simplex and varicella-zoster virus. Acyclovir uses viral thymidine kinase to convert to its active form, acyclovir triphosphate. Through this mechanism of utilizing viral thymidine kinase, acyclovir specifically targets viral DNA preventing its replication in the host.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult participants of both sex with plantar warts will be included in the study

排除标准

  • - Children < 12 years.
  • Pregnant and lactating women.
  • Receiving any treatment for warts within 1 month before the study.
  • Systemic antiviral medication.
  • Previous history of vitamin D or acyclovir hypersensitivity.
  • Vitamin D supplementation.
  • Concurrent other skin disorders.
  • Immunosuppressive disorders or receiving immunosuppressive drugs.
  • Receiving drugs that may alter vitamin D level including prednisone, orlistat, phenytoin and thiazide diuretics.

研究组 & 干预措施

group 1

Active Comparator

this group will be intralesionaly injected with vitamin D3

干预措施: Vitamin D (Drug)

group 2

Active Comparator

this group will be intralesionally injected with acyclovir

干预措施: acyclovir (Drug)

结局指标

主要结局

complete healing rate

时间窗: 12 weeks

Main outcome variable is the complete healing rate among planter warts patients treated with intralesional vitamin D3 compared to those by Intralesional acyclovir

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

maha mostafa ali mostafa

Resident physician of Dermatology, Venereology and Andrology, kom Ombo central hospital

Assiut University

研究点 (1)

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