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临床试验/CTRI/2024/04/065942
CTRI/2024/04/065942尚未招募Phase 3 4

Comparative study of combination of Intralesional Triamcinolone and radiofrequency ablation versus Intralesional Triamcinolone in the treatment of keloids

Bhavana Chaudhary1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
176
试验地点
1
主要终点
Decrease in mean POSAS score

研究概览

简要总结

This is a comparative study of combination of intralesional triamcinolone and radiofrequency ablation versus intralesional triamcinolone injection alone in treatment of keloids. Intralesional triamcinolone injection alone leads to atrophy and hypopigmentaion of surrounding skin and also there are high chance of relapse. These side effects and chances of recurrences are reduced if triamcinolone injection is combined with radiofrequency ablation. So this study is done to compare the both the modalities and give the best of the treatment to the patients. In half of the patients only intralesional triamcinolone injection 40mg/ml will be given at 3 weeks interval for 15 weeks intralesionally and in half of the patients intralesional radiofrequency ablation will be done intralesionally at 3 weeks interval for 15 weeks along with inlesional triamcinolone injection at a dose of 40mg/ml.

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

  • Patient in the age group 18 to 60 years and Patient giving consent for therapy are included in study.

排除标准

  • Patients of age less than 18 years or more than 60 years, pregnant and lactating women, Patient with local/systemic infection, any serious illness, extensive keloids, artificial pacemakers, metals implants and Patients who are previously treated and not giving consent are not included in study.

结局指标

主要结局

Decrease in mean POSAS score

时间窗: 15 weeks

次要结局

  • to compare side effects(15 weeks)

研究者

发起方
Bhavana Chaudhary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bhavana Chaudhary

JN MEDICAL COLLEGE, AMU

研究点 (1)

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