Comparative efficacy of intra-lesional bleomycinsulphate and Immunotherapy with Candida skin testing antigen in the treatment of palmoplantar warts
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clearance of warts
研究概览
简要总结
Various studies have failed to reach at an idealtreatment modality which can be used for treatment of palmo-plantar warts whichare resistant to standard treatment.
Both bleomycin and immunotherapy, individually, haveshown promising results in the management of these warts. But the studies havemostly been open label uncontrolled studies not targeting specifically theresistant palmoplantar warts.
Indian data regarding the efficacy of both bleomycinand immunotherapy is limited. Moreover, no head to head study to compare theirefficacy has been done.
Is bleomycin effective in clearing untreated warts asthere have been reports of distant warts getting cleared after intralesionalbleomycin therapy, but no study evaluating this parameter has been performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age- Adult males and females aged 18-65 years.
- •2.Multiple plantar warts diagnosed on the basis of history and physical examination by two dermatologists.
- •Palmoplantar warts will be defined as sharply defined, hyperkeratotic rough lesions with loss of epithelial ridges over the surface of the lesion with a smooth collar of thickened horn present over the palmar or plantar surfaces.
- •3.Untreated or no treatment in the last four weeks.
排除标准
- •1.Known immune-compromised state such as history of HIV infection, on steroids and other immunosuppressive drugs.
- •2.Past history of immunotherapy or bleomycin sulphate.
- •3.Warts measuring more than 20cm2 in size.
- •4.Local site infection.
- •5.Pregnant and lactating females.
- •6.Any history of chronic cardiac, renal and pulmonary illness, peripheral vascular disease, Raynaud’s disease.
- •7.Unable to give informed consent.
- •8.Allergy to components of candida antigen or bleomycin sulphate.
结局指标
主要结局
Clearance of warts
时间窗: Four weeks after the last dose of agent
次要结局
- CLEARANCE OF DISTANT UNTREATED WART(4 and 12 weeks after the last dose of agent)
- Recurrence of completely cleared lesions(12 weeks after the last dose of agent)
- Delayed clearance of unresolved warts(12 weeks after the last dose of agent)