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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Port-Wine Stain
Interventions: Device: Pulsed Dye Laser
Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Test Site)

Reporting Groups
  Description
Combined Radio Frequency and Pulsed Dye Laser Treatment This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject’s port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects.

Participant Flow:   Overall Study
    Combined Radio Frequency and Pulsed Dye Laser Treatment
Participants Units (Test Site)
STARTED   22   44 
COMPLETED   20   40 
NOT COMPLETED   2    



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Combined Radio Frequency and Pulsed Dye Laser Treatment There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject’s port wine stain area.

Baseline Measures
   Combined Radio Frequency and Pulsed Dye Laser Treatment 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      1   4.5% 
Between 18 and 65 years      21  95.5% 
>=65 years      0   0.0% 
[1] Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  36.4% 
Male      14  63.6% 


  Outcome Measures

1.  Primary:   Percent Change in Blanching of Port Wine Stain   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: J Stuart Nelson
Organization: University of California, Irvine. Beckamn Laser Institute
phone: 9498247997
e-mail: jsnelson@uci.edu



Responsible Party: Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01775722     History of Changes
Other Study ID Numbers: NIH/LAMMP-2012-9092
First Submitted: January 14, 2013
First Posted: January 25, 2013
Results First Submitted: August 27, 2015
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018