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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
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.
CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, France
RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGHôpital Sévigné
Cesson-Sévigné, France
RECRUITINGCHU de Dijon
Dijon, France
RECRUITINGClinique de Turin
Paris, France
RECRUITINGCH de Quimper
Quimper, France
RECRUITINGCHU de reims
Reims, France
RECRUITINGClinique Mathilde
Rouen, France
RECRUITINGCHU de Touloluse
Toulouse, France
RECRUITINGClinique Saint-jean Languedoc
Toulouse, France
RECRUITINGIGA
* 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
Subjective evaluation of the patients on visual analogical scale
Subjective evaluation of the patients on visual analogical scale
Time frame: three months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.