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临床试验/CTRI/2025/10/095881
CTRI/2025/10/095881尚未招募不适用

An interventional prospective study to evaluate and compare the efficacy of the combination of Fractional CO2 Laser (FCL) and Intralesional Triple therapy (ILS-3) against Intralesional Triple Therapy (ILS-3) alone in the treatment of keloids.

Dr Chetan Turale1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
Regression in the dimensions of keloid

研究概览

简要总结

This study is a randomized, open lable, parallel group, single centre trial evaluating and comparing the efficacy of the combination of Fractional CO2 Laser and Intralesional triple therapy against Intralesional triple therapy alone in the treatment of keloids. the primary outcome measures regression in the size of keloids every 3 weeks for first 4 sessions, followed by at 3rd and 6th month. the secondary outcome measures the regression in the symptoms associated with keloids viz. pain and pruritus from the second session.

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

  • Diagnosed cases of keloids more than 18 years of age Patients who have given informed consent.

排除标准

  • Patients not consenting to be a part of the study Paediatric and geriatric patients Pregnant or lactating cases Cases with obvious signs of infection over the keloid or any sign of malignancy Patient with a history of any past treatment for keloids.

结局指标

主要结局

Regression in the dimensions of keloid

时间窗: Every 3 weekly for 4 sessions then at 3rd month and 6th month

次要结局

  • Regression in the associated symptoms viz pain and pruritus(after 2 sessions)

研究者

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

Dr Chetan Turale

Dr Vithalrao Vikhe Patil Foundations hospital Ahmadnagar

研究点 (1)

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