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
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: Timolol + LCP
Device: LCP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272609

Contacts
Contact: PASSERON Thierry, PU-PH +33492039224 passeron.t@chu-nice.fr

Locations
France
CHU de Nice - 4 avenue Reine Victoria Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: PASSERON Thierry, PU-PH    +33492039224    passeron.t@chu-nice.fr   
Principal Investigator: Passeron Thierry, Pu-PH         
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Labreze Christine, pu-ph       'christine.labreze@chu-bordeaux.fr'   
Sub-Investigator: Labreze Christine, pu-ph         
Hôpital Sévigné Recruiting
Cesson Sévigné, France
Contact: Toubel Gérard, Phd       'gerard.toubel@wanadoo.fr'   
Sub-Investigator: TOUBEL Gérard, phd         
CHU de Dijon Recruiting
Dijon, France
Contact: Vabres Pierre, PhD       pierre.vabres@chu-dijon.fr   
Sub-Investigator: Vabres Pierre, PhD         
Clinique de Turin Recruiting
Paris, France
Contact: Mazer Jean-Marc, Phd       'jmmazer@wanadoo.fr'   
Sub-Investigator: Mazer Jean-Marc, PhD         
CH de Quimper Recruiting
Quimper, France
Contact: Plantin Patrick, phd       'p.plantin@ch-cornouaille.fr'   
Sub-Investigator: Plantin Patrick, PhD         
CHU de reims Recruiting
Reims, France
Contact: ESCHARD Christine, Pu-Ph       'ceschard.chu-reims@medical51.apicrypt.org'   
Sub-Investigator: Eschard Christine, Pu-Ph         
Clinique Mathilde Recruiting
Rouen, France
Contact: Rossi Bernard, PHD       'bernard.rossi@clinique-clinique.orange.fr'   
Sub-Investigator: Rossi bernard, PHD         
Clinique Saint-jean Languedoc Recruiting
Toulouse, France
Contact: Dahan serge, phd       'dahan.serge@wanadoo.fr'   
Sub-Investigator: Dahan Serge, phd         
CHU de Touloluse Recruiting
Toulouse, France, 31 0000
Contact: MAZEREEUW juliette, Pu-Ph       'mazereeuw-hautier.j@chu-toulouse.fr'   
Sub-Investigator: MAZEREEUW juliette, Pu-Ph         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01272609     History of Changes
Other Study ID Numbers: 10-PP-11, 2010-022440-20
Study First Received: January 7, 2011
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Melanoma
Port-Wine Stain
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 17, 2014