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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01272609
• Other study ID #: 10-PP-11
• Secondary ID: 2010-022440-20
• Status: Recruiting
• Phase: Phase 3
• First received: January 7, 2011
• Last updated: March 23, 2012
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: PASSERON Thierry, PU-PH
• Phone: +33492039224
• Email: passeron.t[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Melanoma
• Port-Wine Stain

Intervention

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

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital Sévigné	Cesson Sévigné
France	CHU de Dijon	Dijon
France	CHU de Nice - 4 avenue Reine Victoria	Nice	Alpes-Maritimes
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGA	IGA (investigator global assessment) at 3 or 4 marked improvement or complete clearance one month after the third session. Blinded evaluation by two physicians on standardized photos; Colorimetric analysis	one month after the third session	No
Secondary	Subjective evaluation of the patients on visual analogical scale	Subjective evaluation of the patients on visual analogical scale	three months	No