ACTRN12619001370190招募中2 期
Topical Timolol Treatment of Superficial Proliferating Infantile Haemangioma assessing the effectiveness of 0.5% topical timolol gel in the treatment ofsuperficial IH.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Months 至 10 Months（—）
- 性别
- All
入选标准
- •Infants referred with a superficial IH(s) in the cosmetic sensitive areas (face and neck), perineum, buttock and axilla, who are not suitable for oral propranolol treatment.
排除标准
- •Premature infants (less than 6 weeks corrected gestational age)
- •IH on or near mucosal surface such as the eye, mouth and anus
- •Any single lesion larger than 90mm² (e.g., 3x3cm)
- •Multifocal IHs with a total surface area of more than 90mm²
- •IH with ulceration >1x1cm
- •IH with thickness >3mm
- •Subcutaneous IH
- •Any infants with contraindication to ß-blocker use, e.g.:
- •oCardiac disease including: 2nd or 3rd degree atrioventricular heart block, bradycardia, cardiac failure, cardiogenic shock and congenital heart disease
- •oCongenital hyperthyroidism
- •oHypersensitivity to any components of the medication
- •Weight <3.5kg
- •>10 months old
- •Premature infants with a history of apnoea or chronic lung disease
研究者
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