Topical Timolol Gel for the Treatment of Infantile Hemangiomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in size of hemangioma
研究概览
简要总结
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
详细描述
Subjects will be assigned to open label timolol maleate 0.5%. Parents will be instructed to place 1 to 2 drops twice a day in the center of the hemangioma. Subjects are expected to use the study drug as directed every day for a 4 month period.
Subjects will be assessed at baseline, 2 weeks, 4 weeks, and every 4 weeks thereafter for a total of 5 months. Physical exam, photographs to compare size and color intensity, and a scale of improvement will be completed at each visit. Parents will complete a quality of life questionnaire regarding their child's hemangioma and its impact on quality of life.
Subjects who have evidence of worsening would be removed from the study and transferred to the clinic for evaluation and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 7 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed permission for study participation and the use of the patient's images are obtained from the patient's parent(s) or guardian(s),
- •The patient is between 7 days and 6 months of age at the time of enrollment,
- •and a proliferating HOI not requiring systemic therapy is present anywhere on the body, Multiple hemangiomas may be treated on same child, if the hemangioma meets this criteria.
排除标准
- •patients who are not otherwise generally healthy;
- •at risk for imminent ulceration, life-threatening, function-threatening, or ulcerated;
- •patients who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers;
- •patients who have previously been treated for his/her HOI, including any surgical and/or medical procedures;
- •patients whose mothers have been breastfeeding the patient while also being treated with beta-blockers, systemic corticosteroids, vincristine or alpha-interferon;
- •patients who have previously experienced any anaphylactic reactions; patients with an unclear diagnosis of HOI;
- •patients participating in another clinical study or living in the same household as an infant already participating in this study;
- •patients born prematurely who have not yet reached his/her term equivalent age; and patients with parent(s) or guardian(s) who cannot be contacted by telephone in case of emergency.
研究组 & 干预措施
timolol maleate 0.5% gel
timolol gel 1 to 2 drops twice a day to lesions for 4 months
干预措施: timolol maleate 0.5% gel (Drug)
结局指标
主要结局
Change in size of hemangioma
时间窗: Baseline, week 2, 4, 8, 12, 16
At each visit, the size of the IH is assessed in three dimensions (length, width, and height) in cm.
Change in color of hemangioma
时间窗: Baseline, week 2, 4, 8, 12, 16
At each visit, the color intensity (e.g., barely perceptible; pale pink or mottled pink/red; red with central pallor; dull red; bright red) of the IH is assessed on a 6 point scale.
次要结局
- Measure the extent of systemic absorption and the factors which influence absorption(week 2)
研究者
Sheila Friedlander
MD
Rady Children's Hospital, San Diego