Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

• Status: Unknown status
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Timolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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