Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
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 Bosentan (2 mg/kg twice daily, maximum 62,5
mg twice daily) will be given one day before the PDL irradiation and continued for 14 days.
Only one test area of PWS will be treated with PDL. The primary outcome measure will be an
important or complete improvement (Investigator Global Assessment 3 or 4) between treated
area and non treated one, 14 days after the end of the treatment which corresponds to one
month after the laser PDL session. The evaluation will been performed on standardized
pictures by 2 independent physicians blinded to the region treated or not.