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

NCT ID: NCT01166919

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-10-31

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.

Conditions

Port Wine Stain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Tool

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Group Type: EXPERIMENTAL

Matrix Radiofrequency

Intervention Type: DEVICE

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Interventions

Matrix Radiofrequency

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stuart Nelson, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Other Identifiers

20097262

Identifier Type: -

Identifier Source: org_study_id