Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas: A Prospective Double Blinded Placebo Controlled Study
概览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.
概览
简要总结
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
详细描述
At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.
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
- None
入排标准
- 年龄范围
- 1 Month 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.
排除标准
- •Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
- •Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
- •Subjects with IH measuring more than 3cm in size or ulcerated.
- •Children with a history of hypersensitivity to beta blockers.
- •Children with a personal history of asthma.
- •Children with known renal impairment.
- •Children with known cardiac conditions that may predispose to heart block
- •Personal history of hypoglycemia
- •Children on medications that may interact with beta blockers
研究组 & 干预措施
Topical 0.5% Timolol
Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol.
干预措施: topical 0.5% Timolol (Drug)
Placebo
Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
干预措施: Control (placebo) group (Drug)
结局指标
主要结局
Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.
时间窗: at 6 months
This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, \>75%.
次要结局
- Compare Treatment Group to Control Group Improvement Assessments(at 6 months)
研究者
Dr. Alfons Krol, MD, FRCPC
Professor
Oregon Health and Science University