Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
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
- 是
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
Cryotherapy has been given to palmo plantar warts. Frequency: every 2 weekly for 6 weeks
干预措施: Cryotherapy (Procedure)
Intralesional Bleomycin
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
Javaria Rahmatullah
FCPS II Postgraduate Trainee
Jinnah Postgraduate Medical Centre
