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Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

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ClinicalTrials.gov Identifier: NCT01775722
Recruitment Status : Completed
First Posted : January 25, 2013
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
Candela Corporation
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

January 14, 2013
January 25, 2013
August 27, 2015
April 9, 2018
April 9, 2018
December 2012
August 2015   (Final data collection date for primary outcome measure)
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.
Laser Treatment of port wine stain [ Time Frame: up to 12 months ]
Laser Treatment of port wine stain
Complete list of historical versions of study NCT01775722 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
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.
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.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Port-Wine Stain
  • Device: Pulsed Dye Laser
    port wine stain
    Other Name: candela-Laser
  • Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser
    Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
  • Pulsed Dye Laser
    port wine stain treatment using Pulse Dye Laser
    Intervention: Device: Pulsed Dye Laser
  • Experimental: Bipolar Radiofrequency&Pulsed Dye Laser
    Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser
    Intervention: Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
30
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01775722
NIH/LAMMP-2012-9092
Yes
Not Provided
Not Provided
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
  • Candela Corporation
  • Beckman Laser Institute University of California Irvine
Principal Investigator: J. Stuart Nelson, M.D., Ph.D. Beckman Laser Institute, UCI
University of California, Irvine
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP