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

NCT02317679 | Completed Phase 2

• 1 other identifier: 13-PP-10
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Port-wine Stains

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment

  The primary outcome measure will be an important or complete improvement (Investigator Global Assessment) between treated area and non treated one, at 1 month after the start of treatment by bosentan and Pulsed Dye Laser

  at 1 month after the start of treatment with bosentan and Pulsed Dye Laser

Secondary Outcomes (3)

• Patient satisfaction

  1 time at 1 month after the start of treatment with bosentan and Pulsed Dye Laser

• Side effects

  3 times : First time the day of start of bosentan. Second time, one day after the start of treatment with bosentan. The third time, 30 days after the start of treatment with bosentan and pulsed dye laser

• Satisfaction of the patients of the treatment using visual analogical scale

  1 time at 1 month after the start of treatment by bosentan and Pulsed Dye Laser

Study Arms (1)

Bosentan and laser

EXPERIMENTAL

Patients with PWS resistant to PDL treatment will be included. 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). 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.

Drug: Bosentan; Device: Pulsed dye laser (PDL)

Interventions

Bosentan DRUG

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.

Also known as: tracleer

Bosentan and laser

Pulsed dye laser (PDL) DEVICE

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).

Bosentan and laser

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Dermatologie - Hôpital Archet

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Bosentan; Lasers, Dye

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• PASSERON Thierry, Phd

  CHU De Nice, Dermatologie, Hôpital de l'archet 151 route de st-antoine de ginestière 06200 nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: December 16, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

FR (1)