Informations générales (source: ClinicalTrials.gov)
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Interventional
Phase 3
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
janvier 2011
mai 2012
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLINIQUE TURIN | Mazer Jean-Marc, Phd | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Dijon - Dijon - France | Vabres Pierre, PhD | Contact (sur clinicalTrials) | |||
| Clinique Mathilde - Rouen - France | Rossi Bernard, PHD | Contact (sur clinicalTrials) | |||
| Clinique Saint-jean Languedoc - Toulouse - France | Dahan serge, phd | Contact (sur clinicalTrials) | |||
| Hôpital Sévigné - Cesson Sévigné - France | Toubel Gérard, Phd | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de Quimper - Quimper - France | Plantin Patrick, phd | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Bordeaux - France | Labreze Christine, pu-ph | Contact (sur clinicalTrials) | |||
| CHU de Nice - 4 avenue Reine Victoria - 06001 - Nice - Alpes-Maritimes - France | PASSERON Thierry, PU-PH | Contact (sur clinicalTrials) | |||
| CHU de reims - Reims - France | ESCHARD Christine, Pu-Ph | Contact (sur clinicalTrials) | |||
| CHU de Touloluse - 31 0000 - Toulouse - France | MAZEREEUW juliette, Pu-Ph | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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