Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks

This study has been withdrawn prior to enrollment.
(Laser company cannot provide laser unit for the study.)
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01166919
First received: July 20, 2010
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation involving post-capillary venules which produces a light pink to red to dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per 1,000 live births. Approximately 900,000 individuals in the United States and twenty million people worldwide have Port wine stain birthmarks .


Condition Intervention Phase
Port Wine Stain
Device: Matrix Radiofrequency
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Medical Tool [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks


Secondary Outcome Measures:
  • Port Wine Stain blanching [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Blanching responses on test site will be obtained from visible reflectance spectroscopy and Port Wine Stainblood volume fractions in the skin before and after laser treatment


Enrollment: 0
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical Tool
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
Device: Matrix Radiofrequency
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
Other Name: Matrix Radiofrequency

Detailed Description:

The purpose of this research study is to improve port wine stain treatment after Matrix Radiofrequency device treatment. The Matrix Radiofrequency device energy generates fractional deep dermal heating in the region of the electrode matrix to induce skin injury, thus eliciting a wound healing response. Less affected tissue surrounding the matrix points may be stimulated by heat which helps accelerate the healing process, while at the same time minimizing adverse effects such as scarring or changes in the normal skin pigmentation.

The researcher can determine Port wine stain areas treated with the Matrix Radiofrequency device will have improved Port wine stain blanching responses as compared to those areas treated by pulsed dye laser.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Port Wine Stain Birthmarks suitable for comparison testing
  • Age > 18 years of age

Exclusion Criteria:

  • Less than 18 years old
  • Are pregnant or breastfeeding
  • Other history assess by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166919

Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Stuart Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01166919     History of Changes
Other Study ID Numbers: NIH-LAMMP-2009-7262
Study First Received: July 20, 2010
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2015