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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT01272609

First received: January 7, 2011

Last updated: March 23, 2012

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 7, 2011

Last Updated Date

March 23, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IGA [ Time Frame: one month after the third session ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

IGA [ Time Frame: one month after the third session ] [ Designated as safety issue: No ]

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

Change History

Complete list of historical versions of study NCT01272609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective evaluation of the patients on visual analogical scale [ Time Frame: three months ] [ Designated as safety issue: No ]

Subjective evaluation of the patients on visual analogical scale

Original Secondary Outcome Measures ^ICMJE

Subjective evaluation of the patients (on visual analogical scale) [ Time Frame: once time ] [ Designated as safety issue: No ]

Subjective evaluation of the patients (on visual analogical scale)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Melanoma

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: LCP + Timolol
Three sessions of LCP in 595 nm (diameter of spot 7mm; duration of shooting 1,5 ms; Fluence 8 J / cm ²if 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.

Intervention: Drug: Timolol + LCP
Active Comparator: LCP
Three sessions of LCP in 595 nm (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.

Intervention: Device: LCP

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: PASSERON Thierry, PU-PH

+33492039224

passeron.t@chu-nice.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01272609

Other Study ID Numbers ^ICMJE

10-PP-11, 2010-022440-20

Has Data Monitoring Committee

Responsible Party

Centre Hospitalier Universitaire de Nice

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nice

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

PASSERON Thierry, Pu-Ph

CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Information Provided By

Centre Hospitalier Universitaire de Nice

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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