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

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

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166919
Enrollment
0
Registered
2010-07-21
Start date
2009-12-31
Completion date
2011-10-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port Wine Stain

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.

Interventions

DEVICEMatrix Radiofrequency

Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medical Tool8 weeksMatrix Radiofrequency Treatment of Port Wine Stain Birthmarks

Secondary

MeasureTime frameDescription
Port Wine Stain blanching8 weeksBlanching 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026