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