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

March 23, 2012 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Recruiting
        • CHU de Nice - 4 avenue Reine Victoria
        • Contact:
        • Principal Investigator:
          • Passeron Thierry, Pu-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGA
Time Frame: one month after the third session
  • 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective evaluation of the patients on visual analogical scale
Time Frame: three months
Subjective evaluation of the patients on visual analogical scale
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-PP-11
  • 2010-022440-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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