Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study

PHASE2CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

September 30, 2014

Study Completion Date

February 28, 2015

Conditions
Port-wine Stains
Interventions
DRUG

Bosentan

Patients with PWS resistant to PDL treatment will be included. The treatment by Bosentan (twice daily :2 mg/kg and maximum 62,5 mg) will be given 1 day before the PDL irradiation (maximum area treated 100 cm2) and continued for 14 days. The clinical improvement of the lesions will be evaluated by comparing standardized pictures, 14 days after the end of the treatment by Bosentan which corresponds to 1 month after the laser PDL irradiation. The evaluation will be realized by 2 independent physicians blinded to the area treated or not. Hemoglobin and SGOT/SGPT will be controlled before and after the treatment by Bosentan.

DEVICE

Pulsed dye laser (PDL)

A test area of the PWS will be treated by pulsed dye laser (PDL) (λ= 595 nm, 7 mm spot diameter, τp= 1.5 ms, same energy density used at the last session for each subject).

Trial Locations (1)

06200

CHU de Nice - Dermatologie - Hôpital Archet, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER

NCT02317679 - Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study | Biotech Hunter | Biotech Hunter