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

Phase 1

Withdrawn

• Conditions: Port Wine Stain
• Interventions: Device: Matrix Radiofrequency

• Registration Number: NCT01166919
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical Tool	Matrix Radiofrequency	Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Primary Outcome Measures

Name	Time	Method
Medical Tool	8 weeks	Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Secondary Outcome Measures

Name	Time	Method
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