The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to Wound Re-epithelization
研究概览
简要总结
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.
详细描述
Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.
In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.
The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.
In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.
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 weighing between 4-12kg
- •Infants with corrected gestational age 44 weeks - 8 months of age
- •Infant with an ulcerated hemangioma
- •Informed consent
排除标准
- •Ulceration larger than 16cm2
- •Ulcerated hemangioma with active bleeding or infection at time of enrollment
- •Disease threatening hemangioma meeting criteria for oral propranolol
- •Previous treatment with topical/oral corticosteroid or propranolol
- •Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder
- •History of an allergic reaction to Mupirocin or Timolol
- •Currently taking medication that would interact with beta-blockers
研究组 & 干预措施
Timolol 0.5% Gel Forming Solution (GFS)
Half of enrolled subjects will receive topical Timolol
干预措施: Timolol 0.5% Gel Forming Solution (GFS) (Drug)
Mupirocin 2% ointment
Half of enrolled subjects will receive Mupirocin
干预措施: Mupirocin 2% Ointment (Drug)
结局指标
主要结局
Time to Wound Re-epithelization
时间窗: At 3 months
次要结局
- Reduction in Ulcer Surface Area and Depth(At 3 months)
- Investigator's Global Evaluation of Disease(At 3 months)
- Timolol Serum Level(Measured at 1 month into therapy)
- Evaluate number of participants with changes in Glucose levels after drug is applied(Baseline, day 7, day 14)
- Evaluate number of participants with evidence of changes in blood pressure following administration of Timolol 0.5% GFS(Baseline, day 7, day 14)
- Number of participants with presence or absence of Infection(Baseline, day 7, day 14, 1 month, 2 months)
- Number of participants with presence (or absence) of active bleeding(Baseline, day 7, day 14, 1 month, 2 months)
- Evaluate number of participants with changes in Heart Rate after drug is applied(Baseline, day 7, day 14)
- Pain scores (presence or absence) on the Wong-Baker faces scale(Baseline, day 7, day 14, 1 month, 2 months)
研究者
Albert Yan
Chief, Section of Pediatric Dermatology
Children's Hospital of Philadelphia