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临床试验/CTRI/2024/03/063810
CTRI/2024/03/063810尚未招募4 期

A Comparative study on the efficacy of 20% Podophyllin versus 100% Trichloroacetic acid in the treatment of anogenital warts

Dr S Ramya1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Clinical improvement or resolution of anogenital warts

研究概览

简要总结

Wart is a viral infection caused by human papilloma virus (HPV). It can affect both the skin and the mucosa. Anogenital warts refer to the infection of anal and genital mucosa and their adjacent areas. It is mainly transmitted through sexual contact. The lesions appear after the incubation period of 1to 8 months (average 3 months). Anogenital warts may be single or multiple. In men, genital warts most commonly occur on the inner lining of prepuce, frenulum, glans, coronal sulcus, urinary meatus, penile shaft and scrotum. In women, common sites involved are posterior part of introitus, labia, perineum and perianal area, also can involve vagina and cervix. The common presentation is a verrucous papules or pedunculated lesions that may coalesce to form verrucous plaques or cauliflower like growth. Generally the lesions are pink and painless. Depending upon the clinical appearance, warts can be classified as condylomata acuminata, papular wart, keratotic wart and flat topped papular wart. There are various treatment options for anogenital warts such as Podophyllin, Podophyllotoxin, Monochloroacetic acid and Trichloroacetic acid, Cryotherapy,5- Fluorouracil, Imiquimod, Surgical excision, Laser and interferon therapy. The aim of this study is to compare the efficacy of 20% podophyllin and 100% trichloroacetic acid.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with anogenital warts willing to give written informed consent will be divided into group A and group B.25 Patients in group A will receive 20% podophyllin.25 Patients in group B will receive 100% TCA.
  • Maximum 6 sittings will be given at weekly interval.
  • Patients will receive no other therapies during the study.
  • Patients will be advised partner screening and usage of barrier contraception during the study.

排除标准

  • Before starting the study Pregnant and lactating women.
  • During the study If patient develops severe side effects like ulceration / intolerant to pain during the treatment.
  • If patient wants alternate treatment during the study.
  • If patient wants to discontinue the treatment.

结局指标

主要结局

Clinical improvement or resolution of anogenital warts

时间窗: 6 weeks

次要结局

  • Disappearance or Recurrence of of anogenital warts(12 weeks)

研究者

发起方
Dr S Ramya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr S Ramya

Chengalpattu Medical College and Hospital

研究点 (1)

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