search
Back to results

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

Primary Purpose

Port Wine Stain

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Matrix Radiofrequency
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port Wine Stain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Medical Tool

    Arm Description

    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

    Outcomes

    Primary Outcome Measures

    Medical Tool
    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

    Secondary Outcome Measures

    Port Wine Stain blanching
    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

    Full Information

    First Posted
    July 20, 2010
    Last Updated
    October 28, 2022
    Sponsor
    University of California, Irvine
    Collaborators
    Beckman Laser Institute University of California Irvine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01166919
    Brief Title
    Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks
    Official Title
    Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Laser company cannot provide laser unit for the study.
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine
    Collaborators
    Beckman Laser Institute University of California Irvine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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 .
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Port Wine Stain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Medical Tool
    Arm Type
    Experimental
    Arm Description
    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
    Intervention Type
    Device
    Intervention Name(s)
    Matrix Radiofrequency
    Intervention Description
    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
    Primary Outcome Measure Information:
    Title
    Medical Tool
    Description
    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Port Wine Stain blanching
    Description
    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
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stuart Nelson, M.D,PhD
    Organizational Affiliation
    Beckman Laser Institute University of California Irvine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs