Clinical Trial: Port Wine Stains Treatment Matrix RF Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined With PDL Treatment on Port Wine Stains

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.

Detailed Summary:
Sponsor: Syneron Medical

Current Primary Outcome:

• Time to complete healing [ Time Frame: Up to 30 weeks ]
  Assess safety of the Matrix RF treatment for port wine stains
• Adverse events recording and monitoring [ Time Frame: Up to 40 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clearance of port wine stain [ Time Frame: Up to 40 weeks ]
• Lightening of the port wine stain [ Time Frame: Up to 40 weeks ]
  Evaluation of lightening of the port wine stain will be made with reflectance spectrophotometer at all treatments and at 6 and 12 weeks following the last treatment.
• Improvement of port wine stain [ Time Frame: Up to 30 weeks ]
  Assessment to be done by the subject via subject questionnaire during these visits
• Reduction in blood vessel concentration [ Time Frame: Up to 40 weeks ]
  Biopsies taken from consenting subjects at one of the time points will be analyzed

Original Secondary Outcome: Same as current

Information By: Syneron Medical

Dates:
Date Received: April 7, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 30, 2014
Last Verified: November 2014