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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status and phase

Withdrawn
Phase 1

Conditions

Port Wine Stain

Treatments

Device: Matrix Radiofrequency

Study type

Interventional

Funder types

Other

Identifiers

NCT01166919
20097262

Details and patient eligibility

About

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 .

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Medical Tool
Experimental group
Description:
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
Treatment:
Device: Matrix Radiofrequency

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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