Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Depth of infantile hemangioma
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.
详细描述
Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants of 0 to 6 months of age
- •Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment
- •IHs with a surface area of less than 1% of body surface area
- •Skin type III/IV
排除标准
- •Ulcerated IHs.
- •Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg.
- •periorbital and lip IHs.
- •Patients with severe systemic or congenital disease which may affect the patient's safety in this study
研究组 & 干预措施
Superficial Group
Hemangioma depth evaluated by B-ultrasonoscope is lower than or equal to 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma.
干预措施: Timolol Maleate 0.5% Oph Soln (Drug)
Deep Group
Hemangioma depth evaluated by B-ultrasonoscope is more than 6mm. After enrollment, patients would be subject to external use of Timolol Maleate 0.5% Oph Soln for the treatment of hemangioma.
干预措施: Timolol Maleate 0.5% Oph Soln (Drug)
结局指标
主要结局
Depth of infantile hemangioma
时间窗: through study completion, an average of 1 year
At the beginning of treatment, the thickness of hemangioma was measured by b-mode ultrasound at each follow-up.
次要结局
- Dimensions(through study completion, an average of 1 year)
- Color(through study completion, an average of 1 year)
研究者
XiaoXi Lin
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University