Clinical trial NCT01272609: Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Official title: Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: IGA
timeFrame: one month after the third session
Secondary outcomes:
measure: Subjective evaluation of the patients on visual analogical scale
timeFrame: three months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Cesson Sévigné
country: France
facility: Hôpital Sévigné
city: Dijon
country: France
facility: CHU de Dijon
city: Paris
country: France
facility: Clinique de Turin
city: Quimper
country: France
facility: CH de Quimper
city: Reims
country: France
facility: CHU de reims
city: Rouen
country: France
facility: Clinique Mathilde
city: Toulouse
country: France
facility: CHU de Touloluse
city: Toulouse
country: France
facility: Clinique Saint-jean Languedoc
Study officials:
affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: PASSERON Thierry, Pu-Ph
role: PRINCIPAL_INVESTIGATOR
References: