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

Information source: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Timolol + LCP (Drug); LCP (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire de Nice

Official(s) and/or principal investigator(s):
PASSERON Thierry, Pu-Ph, Principal Investigator, Affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Overall contact:
PASSERON Thierry, PU-PH, Phone: +33492039224, Email: passeron.t@chu-nice.fr

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: IGA

Secondary outcome: Subjective evaluation of the patients on visual analogical scale

Eligibility

Minimum age: 6 Months. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

PASSERON Thierry, PU-PH, Phone: +33492039224, Email: passeron.t@chu-nice.fr

CHU de Bordeaux, Bordeaux, France; Recruiting
Labreze Christine, pu-ph, Email: 'christine.labreze@chu-bordeaux.fr'
Labreze Christine, pu-ph, Sub-Investigator

Hôpital Sévigné, Cesson Sévigné, France; Recruiting
Toubel Gérard, Phd, Email: 'gerard.toubel@wanadoo.fr'
TOUBEL Gérard, phd, Sub-Investigator

CHU de Dijon, Dijon, France; Recruiting
Vabres Pierre, PhD, Email: pierre.vabres@chu-dijon.fr
Vabres Pierre, PhD, Sub-Investigator

Clinique de Turin, Paris, France; Recruiting
Mazer Jean-Marc, Phd, Email: 'jmmazer@wanadoo.fr'
Mazer Jean-Marc, PhD, Sub-Investigator

CH de Quimper, Quimper, France; Recruiting
Plantin Patrick, phd, Email: 'p.plantin@ch-cornouaille.fr'
Plantin Patrick, PhD, Sub-Investigator

CHU de reims, Reims, France; Recruiting
ESCHARD Christine, Pu-Ph, Email: 'ceschard.chu-reims@medical51.apicrypt.org'
Eschard Christine, Pu-Ph, Sub-Investigator

Clinique Mathilde, Rouen, France; Recruiting
Rossi Bernard, PHD, Email: 'bernard.rossi@clinique-clinique.orange.fr'
Rossi bernard, PHD, Sub-Investigator

CHU de Touloluse, Toulouse 31 0000, France; Recruiting
MAZEREEUW juliette, Pu-Ph, Email: 'mazereeuw-hautier.j@chu-toulouse.fr'
MAZEREEUW juliette, Pu-Ph, Sub-Investigator

Clinique Saint-jean Languedoc, Toulouse, France; Recruiting
Dahan serge, phd, Email: 'dahan.serge@wanadoo.fr'
Dahan Serge, phd, Sub-Investigator

CHU de Nice - 4 avenue Reine Victoria, Nice, Alpes-Maritimes 06001, France; Recruiting
PASSERON Thierry, PU-PH, Phone: +33492039224, Email: passeron.t@chu-nice.fr
Passeron Thierry, Pu-PH, Principal Investigator

Additional Information

Starting date: January 2011
Last updated: March 23, 2012

Page last updated: August 23, 2015

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