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Withdrawn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
About this trial
This is an interventional treatment trial for Port Wine Stain
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
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
NCT ID
NCT01166919
First Posted
July 20, 2010
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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Withdrawn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
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