NCT01512173已完成2 期
A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
Pierre Fabre Dermatology17 个研究点 分布在 3 个国家目标入组 82 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 17
- 主要终点
- Complete/nearly complete resolution of the Infantile Hemangioma at week 12.
研究概览
简要总结
There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.
Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.
The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Days 至 150 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •only one proliferating Infantile Hemangioma present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter diameter ≥ 1cm and ≤ 5 cm.
排除标准
- •more than one Infantile Hemangioma with largest diameter ≥ 1cm
- •medically unstable health status that may interfere with his/her ability to complete the study
- •Infantile Hemangioma requires, according to Investigator's judgment, a systemic treatment
- •the patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH
研究组 & 干预措施
propranolol gel
Experimental
干预措施: propranolol gel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Complete/nearly complete resolution of the Infantile Hemangioma at week 12.
时间窗: week 12
Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline
次要结局
- Persistence of efficacy 12 weeks after the end of treatment(Week 24)
- Local tolerance of the propranolol gel(description over time by treatment group)(week 2, week 4, week 8 and week 12)
- On-site parent(s) or guardian(s) qualitative assessments of efficacy(week 2 , week 4, week 8, week 12 and week 24)
- Safety profile (descriptive analysis of AE)(Day 0, week 2, week 4, week 8, week 12 and week 24)
研究者
研究点 (17)
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