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

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: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Drug: Timolol + LCP; Device: LCP

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux
  • Cesson-Sévigné, France
    • Hôpital Sévigné
  • Dijon, France
    • CHU de Dijon
  • Paris, France
    • Clinique de Turin
  • Quimper, France
    • CH de Quimper
  • Reims, France
    • CHU de Reims
  • Rouen, France
    • Clinique Mathilde
  • Toulouse, France
    • Clinique Saint-Jean Languedoc
  • Toulouse, France, 31 0000
    • CHU de Touloluse
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice - 4 avenue Reine Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Subjective evaluation of the patients on visual analogical scale	three months

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): February 16, 2011
• Primary Completion (Actual): September 24, 2012
• Study Completion (Actual): September 24, 2012

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimated): January 10, 2011

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Amines; Alcohols; Propanolamines; Amino Alcohols; Propanols; Thiadiazoles; Morpholines; Oxazines; Timolol
• Other Study ID Numbers: 10-PP-11; 2010-022440-20 (EudraCT Number)