Intralesional Vitamin D3 Versus Intralesional Acyclovir in Treatment of Plantar Warts
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
- 否
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
this group will be intralesionaly injected with vitamin D3
干预措施: Vitamin D (Drug)
group 2
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
maha mostafa ali mostafa
Resident physician of Dermatology, Venereology and Andrology, kom Ombo central hospital
Assiut University
