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TERMINATED
NCT01272609
PHASE3

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2011-02-16

Completion Date

2012-09-24

Last Updated

2026-06-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Timolol + LCP

Three sessions of LCP in 595nm (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. 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.

DEVICE

LCP

Three sessions of LCP in 595nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ²if LCP of Candela © or 7 J / cm ²if LCP of Cynosure © spaced out of 1 month.

Locations (10)

CHU de Nice - 4 avenue Reine Victoria

Nice, Alpes-Maritimes, France

CHU de Bordeaux

Bordeaux, France

Hôpital Sévigné

Cesson-Sévigné, France

CHU de Dijon

Dijon, France

Clinique de Turin

Paris, France

CH de Quimper

Quimper, France

CHU de reims

Reims, France

Clinique Mathilde

Rouen, France

CHU de Touloluse

Toulouse, France

Clinique Saint-jean Languedoc

Toulouse, France