Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
April 9, 2018
CompletedNovember 2, 2022
October 1, 2022
2.7 years
January 14, 2013
August 27, 2015
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Study Arms (2)
Pulsed Dye Laser
OTHERport wine stain treatment using Pulse Dye Laser
Bipolar Radiofrequency&Pulsed Dye Laser
EXPERIMENTALPort wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser
Interventions
Combined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Candela Corporationcollaborator
- Beckman Laser Institute University of California Irvinecollaborator
Study Sites (1)
Beckman Laser Institute Medical Clinic
Irvine, California, 92612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- J Stuart Nelson
- Organization
- University of California, Irvine. Beckamn Laser Institute
Study Officials
- PRINCIPAL INVESTIGATOR
J. Stuart Nelson, M.D., Ph.D.
Beckman Laser Institute, UCI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 25, 2013
Study Start
December 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 2, 2022
Results First Posted
April 9, 2018
Record last verified: 2022-10