A combination of Triamcinolone Acetonide 5 Fluorouracil 5 FU and Verapamil intralesional injection for treatment of Keloid in adults An Interventional Study
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
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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.
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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.
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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.
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5-Fluorouracil(5-FU) selectively inhibits fibroblast proliferation and collagen synthesis.
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Currently, intralesional corticosteroids is the gold standard non surgical management for keloids.
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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.
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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
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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
- Hypopigmentation
- Telangiectasia
- Ulceration
- Vesicle followed by erosion
- 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
Dr Nachiket Palaskar
YCM hospital
