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临床试验/NCT05023408
NCT05023408已完成2 期

Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
154
试验地点
1
主要终点
change in morphology of cutaneous warts.

研究概览

简要总结

The purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts.

详细描述

This study was conducted in the Department of Dermatology of Jinnah Postgraduate Medical Centre, Karachi from January to June 2021 after receiving approval from the institutional ethical and research committee of hospital.

Sample size was calculated through NCSS software. Total of one fifty four non-admitted patients were assigned two study groups with equal sample size of 77 randomly through lottery method. Those patients aged between 18 to 60 years of either gender with cutaneous warts for > 1 week to 48 weeks were included after written informed consent. Patients treated previously for warts by any methodology, with history of vascular disease, immunocompromised, hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine were excluded.

All demography, clinical history was recorded by a principal investigator on a predesigned Performa , informed written consent was taken before enrolment.

Group A received intralesional bleomycin 0.1% therapy until the lesion blanched. It was prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so that concentration became 1mg/1ml (0.1%). Group B patients were treated with liquid nitrogen with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm extra healthy skin margin until the lesion blanched.

Follow-up was carried out at 02, 04 and 06 weeks. Both the groups were assessed and compared for efficacy after 6 weeks of therapy. SPSS 23 was used for analyzing data.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Age18 to 60 years
  • Either gender.
  • Diagnosed cases of cutaneous warts as per operational definition for > 1 week to 48 weeks.

排除标准

  • • Previously treated for warts by any methodology, assessed by history and clinically.
  • Patients with hypertension, cardiovascular disorder, pregnancy, lactation, vascular diseases, assessed by history, clinically & by positive autoimmune profile.
  • Hypersensitivity to lidocaine.
  • No given informed written consent.

研究组 & 干预措施

Cryotherapy

Experimental

Cryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks

干预措施: Cryotherapy (Procedure)

Intralesional Bleomycin

Experimental

Intralesional Bleomycin has been given to palmo plantar warts. Generic name: Bleomycin Dose: 1mg/1ml (0.1%) Frequency: every 2 weekly for 6 weeks.

干预措施: Bleomycin Injection (Drug)

结局指标

主要结局

change in morphology of cutaneous warts.

时间窗: 6 weeks

There is complete remission of cutaneous warts, assessed clinically

次要结局

未报告次要终点

研究者

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

Javaria Rahmatullah

FCPS II Postgraduate Trainee

Jinnah Postgraduate Medical Centre

研究点 (1)

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