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

Centre Hospitalier Universitaire de Nice

Status and phase: Unknown; Phase 3

Conditions: Melanoma

Treatments: Device: LCP; Drug: Timolol + LCP

Study type: Interventional

Funder types: Other

Identifiers

NCT01272609

10-PP-11

2010-022440-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

LCP + Timolol

Experimental group

Description:

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.

Treatment:

Drug: Timolol + LCP

LCP

Active Comparator group

Description:

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.

Treatment:

Device: LCP