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

Port Wine Stain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01166919
• Other study ID #: 20097262
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Intervention

Device:
• Matrix Radiofrequency
Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Tool	Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks	8 weeks
Secondary	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	8 weeks