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
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