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Completed

NCT Number: NCT01775722

Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

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Key information

Conditions

Port-Wine Stain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Laser Institute Medical Clinic

Irvine, California, 92612, United States

About this study

The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Port Wine Stain suitable for comparison testing
  • Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
  • Apparent good health as documented by medical history
  • Ability to understand and carry out subject instructions

Exclusion criteria

  • History of photodermatoses or skin cancer
  • Any therapy within the previous two months to the proposed port wine stain treatment sites
  • Current participation in any other investigational drug or device evaluation
  • Concurrent use of known photosensitizing drugs
  • Inability to understand and carry out instructions

Treatment and study plan

Pulsed dye laser

Device

port wine stain

Other names: candela-Laser

Combined Bipolar Radiofrequency&Pulsed Dye Laser

Device

Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Primary outcomes

  1. Percent Change in Blanching of Port Wine Stain

    Time frame: 8 weeks

    Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine
  • Candela Corporation

Registry information

Official study title

Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2013
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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