Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 20
- 主要终点
- IGA
研究概览
简要总结
Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS.
Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 6 months to 18 year-old.
- •PWS of the face
- •No prior treatement with PDL
- •Membership or beneficiary of a national insurance scheme.
- •Consent signed by the parents and by the patient if he is old enough to understand
排除标准
- •Child with whom the angioma plan was already handled by laser or pulsed lamp
- •Histories of asthma or obstructive bronchitis
- •severe allergic Rhinitis and hyper bronchial ability to react
- •Bradycardie sinusale, block auriculo-ventriculaires of the second or third degree
- •unchecked Cardiac insufficiency
- •cardiogenic Shock
- •untreated Phéochromocytome
- •Sentimentality in the timolol or in one of these excipients, and\or in the other bétabloquants
- •Taken by floctafénine or by sultopride
- •Taken of bétabloquants by oral route, of inhibitors calcic or of amiodarone
- •severe peripheral circulatory Disorders(Confusions of Raynaud)
- •arterial Low blood pressure
- •Pregnancy and feeding
- •Absence of effective contraception at the girls old enough to procreate
- •Contraindication in the use of cream with lidocaïne and with prilocaïne
研究组 & 干预措施
LCP
Three sessions of LCP in 595 nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ² if LCP of Candela © or 7 J / cm ² if LCP of Cynosure © spaced out of 1 month.
干预措施: LCP (Device)
LCP + Timolol
Three sessions of LCP in 595 nm (diameter of spot 7mm; duration of shooting 1,5 ms; Fluence 8 J / cm ²if LCP of Candela © or 7 J / cm ² if LCP of Cynosure ©) spaced out of 1 month. Twice-daily applications on the zone treated by the LCP of timolol frost and will be begun that very evening by the first session and will be pursued 15j after the 3rd session of LCP. The maximum surface of treatment will be 100 cms ².
干预措施: Timolol + LCP (Drug)
结局指标
主要结局
IGA
时间窗: one month after the third session
* IGA (investigator global assessment) at 3 or 4 marked improvement or complete clearance one month after the third session. Blinded evaluation by two physicians on standardized photos * Colorimetric analysis
次要结局
- Subjective evaluation of the patients on visual analogical scale(three months)