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

Sponsor
University of California, Irvine (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01166919
Collaborator
Beckman Laser Institute University of California Irvine (Other)
0
Enrollment
1
Arm
22
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Matrix Radiofrequency
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Medical Tool

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Device: Matrix Radiofrequency
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Outcome Measures

Primary Outcome Measures

  1. Medical Tool [8 weeks]

    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Secondary Outcome Measures

  1. Port Wine Stain blanching [8 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
Other Study ID Numbers:
  • NIH-LAMMP-2009-7262
First Posted:
Jul 21, 2010
Last Update Posted:
Feb 10, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Hemangioma, Capillary
Port-Wine Stain

Study Results

No Results Posted as of Feb 10, 2017