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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Dec 15, 2014

Keywords

ClinConnect Summary

Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However, the outcomes are highly variable due to the new angiogenesis occurring after laser irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred after treatment of port-wine stains by PDL . The main objective of this pilot clinical trial is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the PDL treatment will be included. The treatment by B...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children of 7 years old and over or adults aged under 60
• • with a resistant port-wine stain after treatment by PDL will be included in this pilot study.
• • The agreement of the parents and the child or the patient alone if major will be required.
• • Subjects have to be registered to the social security.
• • An informed consent will have to be signed by the parents or the patient if of a suitable age or the patient alone if major.
• • An efficient contraception will be mandatory if the patient is female and an age to give birth.
• Exclusion criteria:
• • Hypersensitivity to the Bosentan or to one of its excipients.
• • Mild to severe liver disease corresponding to the Child-Pugh Score B or C.
• • Serum levels of ASAT and/or ALAT greater three times the upper limit of normal. - Concurrent use of cyclosporine.
• • Pregnancy.