Back to resultsCombined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Primary Purpose
Port-Wine Stain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed Dye Laser
Combined Bipolar Radiofrequency&Pulsed Dye Laser
Sponsored by
About this trial
This is an interventional treatment trial for Port-Wine Stain
Eligibility Criteria
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
Sites / Locations
- Beckman Laser Institute Medical Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Pulsed Dye Laser
Bipolar Radiofrequency&Pulsed Dye Laser
Arm Description
port wine stain treatment using Pulse Dye Laser
Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser
Outcomes
Primary Outcome Measures
Percent Change in Blanching of Port Wine Stain
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01775722
First Posted
January 14, 2013
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Candela Corporation, Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01775722
Brief Title
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Official Title
Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Candela Corporation, Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Dye Laser
Arm Type
Other
Arm Description
port wine stain treatment using Pulse Dye Laser
Arm Title
Bipolar Radiofrequency&Pulsed Dye Laser
Arm Type
Experimental
Arm Description
Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser
Other Intervention Name(s)
candela-Laser
Intervention Description
port wine stain
Intervention Type
Device
Intervention Name(s)
Combined Bipolar Radiofrequency&Pulsed Dye Laser
Intervention Description
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Primary Outcome Measure Information:
Title
Percent Change in Blanching of Port Wine Stain
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Stuart Nelson, M.D., Ph.D.
Organizational Affiliation
Beckman Laser Institute, UCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical Clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
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