Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01272609|
Recruitment Status : Unknown
Verified January 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : January 10, 2011
Last Update Posted : March 26, 2012
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 or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Timolol + LCP Device: LCP||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||May 2012|
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.
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.
- 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
- Subjective evaluation of the patients on visual analogical scale [ Time Frame: three months ]Subjective evaluation of the patients on visual analogical scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272609
|Contact: PASSERON Thierry, PU-PHfirstname.lastname@example.org|
|CHU de Nice - 4 avenue Reine Victoria||Recruiting|
|Nice, Alpes-Maritimes, France, 06001|
|Contact: PASSERON Thierry, PU-PH +33492039224 email@example.com|
|Principal Investigator: Passeron Thierry, Pu-PH|
|CHU de Bordeaux||Recruiting|
|Contact: Labreze Christine, pu-ph 'firstname.lastname@example.org'|
|Sub-Investigator: Labreze Christine, pu-ph|
|Cesson Sévigné, France|
|Contact: Toubel Gérard, Phd 'email@example.com'|
|Sub-Investigator: TOUBEL Gérard, phd|
|CHU de Dijon||Recruiting|
|Contact: Vabres Pierre, PhD firstname.lastname@example.org|
|Sub-Investigator: Vabres Pierre, PhD|
|Clinique de Turin||Recruiting|
|Contact: Mazer Jean-Marc, Phd 'email@example.com'|
|Sub-Investigator: Mazer Jean-Marc, PhD|
|CH de Quimper||Recruiting|
|Contact: Plantin Patrick, phd 'firstname.lastname@example.org'|
|Sub-Investigator: Plantin Patrick, PhD|
|CHU de reims||Recruiting|
|Contact: ESCHARD Christine, Pu-Ph 'email@example.com'|
|Sub-Investigator: Eschard Christine, Pu-Ph|
|Contact: Rossi Bernard, PHD 'firstname.lastname@example.org'|
|Sub-Investigator: Rossi bernard, PHD|
|CHU de Touloluse||Recruiting|
|Toulouse, France, 31 0000|
|Contact: MAZEREEUW juliette, Pu-Ph 'email@example.com'|
|Sub-Investigator: MAZEREEUW juliette, Pu-Ph|
|Clinique Saint-jean Languedoc||Recruiting|
|Contact: Dahan serge, phd 'firstname.lastname@example.org'|
|Sub-Investigator: Dahan Serge, phd|
|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|