The Efficacy of Intralesional Measles, Mumps, Rubella (MMR) Vaccine, Intralesional Candidal Antigen and Topical Podophyllin in Treatment of Genital Warts: A Comparative Study
试验速览
- 阶段
- 3 期
- 入组人数
- 45
- 主要终点
- Cure rate
研究概览
简要总结
This study compares the safety and efficacy of intralesional Candidal antigen versus Intralesional MMR vaccine versus podophyllin for treatment of genital warts.
详细描述
Anogenital human papillomavirus (HPV) is a highly prevalent sexually transmitted infection ,seen predominantly in young adults.
Condyloma acuminata or benign anogenital warts are typically caused by HPV-6 OR 11 which are considered low risk types.Persistent infection with high risk HPV types predominantly HPV-16 and 18 is the primary and major cause of cervical cancers and a subset of vaginal,vulvar, penile , anal ,oropharyngeal and rarely squamous cell carcinoma of the digits.
Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV.
Anogenital warts may appear as a single lesion or in clusters as flat, flesh-coloured to pigmented plaques or rough-surfaced papules and exophytic nodules.
The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and lasers; antiproliferative agents such as bleomycin, podophyllin, podophyllotoxin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids.
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
- None
入排标准
- 年龄范围
- 3 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with anogenital warts with ages ranging from 3 to 50 years
- •Genital warts resistant to treatment
- •Genital warts that had relapsed at least once after treatment with any of the tissue-destructive modalities.
排除标准
- •Patients with any evidence of immunosuppression
- •Eczematous skin disorder
- •Those with any history of hypersensitivity to Candida albicans antigen
- •Pregnant or lactating women.
研究组 & 干预措施
Intralesional MMR vaccine
Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
干预措施: MMR vaccine (Biological)
intralesional candida antigen
intralesional candida antigen in genital warts
干预措施: Candida antigen (Biological)
Topical Podophyllin
Topical Podophyllin in genital warts
干预措施: Topical Podophyllin (Drug)
结局指标
主要结局
Cure rate
时间窗: 45 days
Assess cure rate of MMR vaccine and candida antigen and topical podophyllin in treatment of genital warts (complete disappearance of lesions) in 45 days duration and compare efficacy of the measures.
次要结局
未报告次要终点
研究者
Meriam Mamdouh Boshra
principle investigator
Assiut University