Back to resultsTreatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Primary Purpose
Melanoma
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Timolol + LCP
LCP
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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
Sites / Locations
- CHU de Nice - 4 avenue Reine VictoriaRecruiting
- CHU de BordeauxRecruiting
- Hôpital SévignéRecruiting
- CHU de DijonRecruiting
- Clinique de TurinRecruiting
- CH de QuimperRecruiting
- CHU de reimsRecruiting
- Clinique MathildeRecruiting
- CHU de TouloluseRecruiting
- Clinique Saint-jean LanguedocRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LCP + Timolol
LCP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Subjective evaluation of the patients on visual analogical scale
Subjective evaluation of the patients on visual analogical scale
Full Information
NCT ID
NCT01272609
First Posted
January 7, 2011
Last Updated
March 23, 2012
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01272609
Brief Title
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Official Title
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LCP + Timolol
Arm Type
Experimental
Arm Description
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.
Arm Title
LCP
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Timolol + LCP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LCP
Intervention Description
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.
Primary Outcome Measure Information:
Title
IGA
Description
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
Time Frame
one month after the third session
Secondary Outcome Measure Information:
Title
Subjective evaluation of the patients on visual analogical scale
Description
Subjective evaluation of the patients on visual analogical scale
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PASSERON Thierry, PU-PH
Phone
+33492039224
Email
passeron.t@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PASSERON Thierry, Pu-Ph
Organizational Affiliation
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - 4 avenue Reine Victoria
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PASSERON Thierry, PU-PH
Phone
+33492039224
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, Pu-PH
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Labreze Christine, pu-ph
Email
'christine.labreze@chu-bordeaux.fr'
First Name & Middle Initial & Last Name & Degree
Labreze Christine, pu-ph
Facility Name
Hôpital Sévigné
City
Cesson Sévigné
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toubel Gérard, Phd
Email
'gerard.toubel@wanadoo.fr'
First Name & Middle Initial & Last Name & Degree
TOUBEL Gérard, phd
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vabres Pierre, PhD
Email
pierre.vabres@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Vabres Pierre, PhD
Facility Name
Clinique de Turin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mazer Jean-Marc, Phd
Email
'jmmazer@wanadoo.fr'
First Name & Middle Initial & Last Name & Degree
Mazer Jean-Marc, PhD
Facility Name
CH de Quimper
City
Quimper
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Plantin Patrick, phd
Email
'p.plantin@ch-cornouaille.fr'
First Name & Middle Initial & Last Name & Degree
Plantin Patrick, PhD
Facility Name
CHU de reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ESCHARD Christine, Pu-Ph
Email
'ceschard.chu-reims@medical51.apicrypt.org'
First Name & Middle Initial & Last Name & Degree
Eschard Christine, Pu-Ph
Facility Name
Clinique Mathilde
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rossi Bernard, PHD
Email
'bernard.rossi@clinique-clinique.orange.fr'
First Name & Middle Initial & Last Name & Degree
Rossi bernard, PHD
Facility Name
CHU de Touloluse
City
Toulouse
ZIP/Postal Code
31 0000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAZEREEUW juliette, Pu-Ph
Email
'mazereeuw-hautier.j@chu-toulouse.fr'
First Name & Middle Initial & Last Name & Degree
MAZEREEUW juliette, Pu-Ph
Facility Name
Clinique Saint-jean Languedoc
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dahan serge, phd
Email
'dahan.serge@wanadoo.fr'
First Name & Middle Initial & Last Name & Degree
Dahan Serge, phd
12. IPD Sharing Statement
Learn more about this trial
Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
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