Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pilot Study on the Use of the EMatrix RF (Radiofrequency) for Treatment of Port Wine Stain Birthmarks

This study has been withdrawn prior to enrollment.
(Laser company cannot provide laser unit for the study.)
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine Identifier:
First received: July 20, 2010
Last updated: October 28, 2011
Last verified: October 2011

The purpose of this research study is to improve port wine stain (PWS) treatment after Matrix RF radiofrequency device treatment. It is unknown whether or not the radiofrequency device applied to the skin will improve PWS fading.

Condition Intervention Phase
Port Wine Stain
Procedure: Matrix RF 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 EMatrix RF (Radiofrequency) for Treatment of Port Wine Stain Birthmarks

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

Primary Outcome Measures:
  • improve PWS therapeutic [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
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: port wine stain birthmark Procedure: Matrix RF radiofrequency
Matrix RF radiofrequency

Detailed Description:

The researcher want to compare the blanching responses of the area treated with the EMatrix as compare to the area treated by the pulsed dye laser. This study will give information on whether or not the radiofrequency device will improve PWS fading as compared to the pulsed dye laser.


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

Inclusion Criteria:

  • PWS 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 identifier: NCT01166919

United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Principal Investigator: Stuart Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine Identifier: NCT01166919     History of Changes
Other Study ID Numbers: NIH NIBIB;HS#2009-7262
Study First Received: July 20, 2010
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases processed this record on March 03, 2015