Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Pulsed Dye Laser
port wine stain treatment using Pulse Dye Laser
Device: Pulsed Dye Laser
port wine stain
Other Names:
  • candela-Laser
EXPERIMENTAL: Bipolar Radiofrequency&Pulsed Dye Laser
Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser
Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine
Candela Corporation

Investigators

  • Principal Investigator: J. Stuart Nelson, M.D., Ph.D., Beckman Laser Institute, UCI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (ESTIMATE)

January 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20129092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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