CTRI/2023/08/056626尚未招募2 期
To evaluate the role of intralesional bleomycin in cases of periocular capillary hemangioma unresponsive to oral propranolol
Rp center institute of ophthalmic sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年8月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Comparing the area of the lesion , maximum horizontal diameter , maximum vertical diameter , color change , percentage of area reduction
研究概览
简要总结
Prospective interventional study to evaluate the role of intralesional bleomycin in patients of periocular hemangiomas unresponsive to oral propranolol .since surgery , corticosteroids and radiation therapy has side effects.Currently there is paucity of prospective interventional studies regarding the same.Retrospective studies showed benefit of the intralesional bleomycin injections
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •All periocular capillary hemangioma patients 0-18 years who are resistant to oral propranolol.
排除标准
- •Age > 18 years Capillary hemangioma responding to oral propranolol.
结局指标
主要结局
Comparing the area of the lesion , maximum horizontal diameter , maximum vertical diameter , color change , percentage of area reduction
时间窗: At baseline , 1 week , 4 weeks , 2 months , 3 months and 6 months
次要结局
- Change in BCVA , percentage reduction in area(2 weeks , 1 month , 3 months , 6 months)
研究者
研究点 (1)
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