NCT01166919

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 .

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

July 20, 2010

Last Update Submit

October 28, 2022

Conditions

Port Wine Stain

Outcome Measures

Primary Outcomes (1)

  • Medical Tool

    Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

    8 weeks

Secondary Outcomes (1)

  • Port Wine Stain blanching

    8 weeks

Study Arms (1)

Medical Tool

EXPERIMENTAL

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Device: Matrix Radiofrequency

Interventions

Matrix RadiofrequencyDEVICE

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Medical Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Port Wine Stain Birthmarks suitable for comparison testing
  • Age \> 18 years of age

You may not qualify if:

  • Less than 18 years old
  • Are pregnant or breastfeeding
  • Other history assess by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Stuart Nelson, M.D,PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 21, 2010

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 1, 2022

Record last verified: 2022-10