CTRI/2024/09/073901尚未招募3 期
A prospective study on assessment of efficacy of Intralesional Botulinum toxin type A injection in keloid and hypertrophic scar
Swathi T1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the size of the lesion
研究概览
简要总结
It is a prospective interventional single arm study to assess the efficacy of Intralesional Botulinum toxin type A injection done in patients with keloid and hypertrophic scars. Patients fulfilling the inclusion criteria are treated with Intralesional Botulinum toxin type A injection at a dose of 5 units/cm3 not exceeding 100 units per session. It will be administered once every 8 weeks till the lesion flattens or for a maximum period of 6 months. Patients will be followed up for 6 months after the treatment.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 65 years Sex: male and female Patients willing for consent, study and follow up regularly Patients with untreated Keloid and Hypertrophic scar.
排除标准
- •Age less than 18 years and more than 65 years Pregnancy Lactation Local infection Patients on retinoids or steroids Severe systemic disease Pre existing neuromuscular or cardiovascular diseases Patients not willing for consent,study or follow up HIV/Hepatitis.
结局指标
主要结局
Reduction in the size of the lesion
时间窗: Every month for 6 months
次要结局
- Reduction in symptoms like itching and pain(Every month for 6 months)
研究者
Dr Swathi T
The Tamilnadu Dr.M.G.R Medical University, Chennai.
研究点 (1)
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