Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study
Condition: Port-wine Stains
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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 (maximum surface 100 cm²)
      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.
    

Intervention name(s): Bosentan; Pulsed dye laser (PDL)
Intervention type(s): Drug; Device
Intervention description(s): 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.; 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).
Other intervention name(s): tracleer
Intervention MeSH terms: Bosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment