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临床试验/CTRI/2024/09/073176
CTRI/2024/09/073176招募中不适用

A combination of Triamcinolone Acetonide 5 Fluorouracil 5 FU and Verapamil intralesional injection for treatment of Keloid in adults An Interventional Study

YCM Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
31
试验地点
1
主要终点
To evaluate the efficacy of combination of Triamcinolone

研究概览

简要总结

  1. Keloid still possesses a challenge for clinicians as they are difficult to treat and there is no specific treatment guideline for it.Many treatment modalities are there and various medicine injections have been tried in the treatment of keloid.

  2. Verapamil, a calcium channel antagonist, has been recommended in the management of keloids because of its ability to decrease extracellular matrix production and modify fibroblast to increase secretion of procollagenase.

  3. Intralesional corticosteroids injection , provide the best relief of local symptoms as well as flattening of the scars themselves due to their anti inflammatory and scar enhancing properties.

  4. 5-Fluorouracil(5-FU) selectively inhibits fibroblast proliferation and collagen synthesis.

  5. Currently, intralesional corticosteroids is the gold standard non surgical management for keloids.

  6. Two medicine combinations of Triamcinolone Acetonide (40 mg/ml) +5 FU (50mg/ml) and Triamcinolone Acetonide (40 mg/ml) +Verapamil (2.5mg/ml) have been tried with good results.

  7. The introduction of a triple combination therapy of Triamcinolone Acetonide (40 mg/ml), 5 FU (50mg/ml), and Verapamil (2.5mg/ml) aims to enhance treatment efficacy and expedite the resolution of keloid

  8. The lesions and symptoms associated as such impacts the social and interpersonal relation of patients.So it is very important to find solution that will decrease the recurrence and help patient to achieve easy and faster remission.

Update 1:

Number of patients enrolled - 94

Number of patients who completed the study - 10

Number of patients showing loss to follow up - 27

Number of patients showing no result - 1

Adverse Effects - All side-effects were seen locally over keloid

  1. Hypopigmentation
  2. Telangiectasia
  3. Ulceration
  4. Vesicle followed by erosion
  5. Comedones

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients having keloid and willing to give a consent 2) Age group above 18 years.

排除标准

  • Secondary infection of keloid 2) Patients having blood dyscrasias.

结局指标

主要结局

To evaluate the efficacy of combination of Triamcinolone

时间窗: 18 months

Acetonide, 5-Fluorouracil(5-FU) and Verapamil intralesional injection therapy

时间窗: 18 months

in the treatment of keloid , employing the Patient and Observer Scar

时间窗: 18 months

Assessment Scale (POSAS)

时间窗: 18 months

次要结局

  • To study the adverse effects following the injection .(18 months)

研究者

发起方
YCM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nachiket Palaskar

YCM hospital

研究点 (1)

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