Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
NCT ID: NCT01272609
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
44 participants
INTERVENTIONAL
2011-01-31
2012-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* 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
* 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
6 Months
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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PASSERON Thierry, Pu-Ph
Role: PRINCIPAL_INVESTIGATOR
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Locations
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CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, France
CHU de Bordeaux
Bordeaux, , France
Hôpital Sévigné
Cesson-Sévigné, , France
CHU de Dijon
Dijon, , France
Clinique de Turin
Paris, , France
CH de Quimper
Quimper, , France
CHU de reims
Reims, , France
Clinique Mathilde
Rouen, , France
CHU de Touloluse
Toulouse, , France
Clinique Saint-jean Languedoc
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010-022440-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
10-PP-11
Identifier Type: -
Identifier Source: org_study_id
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