跳至主要内容
临床试验/NCT05897112
NCT05897112已完成1 期

Comparison of 10% Potassium Hydroxide Solution Versus Cryotherapy in the Treatment of Molluscum Contagiosum

Combined Military Hospital Abbottabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Efficacy was assessed at 12th week by the clearance of lesion or not

研究概览

简要总结

A total of sixty patients presented to the outpatient dermatology department of Combined military hospital (CMH) Abbottabad with signs of molluscum contagiosum clinically diagnosed meeting inclusion criteria were enrolled. Sample size was calculated using WHO sample size calculator. They were divided into two groups i.e Group A and Group B using lottery method. Patients in Group A were subjected to cryotherapy (liquid nitrogen gas) whereas patients in Group B patients were subjected to 10% potassium hydroxide solution for 3 weeks and were followed up at 2nd, 4th, 8th and 12th week for observing the progress of therapy in both groups on each follow up visit and ascertaining the efficacy respectively.

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
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of molluscum contagiosum having 3-20 lesion
  • no history of treatment before
  • willingness to participate (given by parents)

排除标准

  • Patients with facial lesions
  • known immunodeficiency
  • tendency for hypertrophic scarring
  • known hypersensitivity

研究组 & 干预措施

Group A received cryotherapy

Active Comparator

Group A were subjected to weekly cryotherapy with a cotton stick dip ped in Liquid Nitrogen for 02 Freezes and Thaw Cycle of 07 seconds with each cycle 10 seconds apart for 3 weeks

干预措施: Group A received cryotherpay (Drug)

Group B received 10% Potassium Hydroxide Solution

Active Comparator

Group B applied 10% Potassium Hydroxide solution twice daily with the help of a cotton tip applicator until lesion showed signs of inflammation or clearance for 3 weeks

干预措施: Group B received 10% Potassium Hydroxide Solution (Drug)

结局指标

主要结局

Efficacy was assessed at 12th week by the clearance of lesion or not

时间窗: 12 weeks

Final evaluation in terms of efficacy was done at the follow up visit in 12th week and the method was termed as effective (Yes) on achieving complete clearance of lesions confirmed on clinical \& physical examination of the affected areas by a consultant dermatologist using dermoscopy showing complete resolution of lesions. However, if lesions were not completely cleared at the end of 12th week, the treatment method was labelled as ineffective (No).

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Abbottabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

danyal sajjad

Principal Investigator

Combined Military Hospital Abbottabad

研究点 (1)

Loading locations...

相似试验