Combined Photodynamic and Pulsed Dye Laser Treatment of Port Wine Stains (PDT/PDL)

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00556946
First received: November 9, 2007
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: February 5, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Port Wine Stains
Intervention: Drug: Combined Photodynamic & Pulsed Dye Laser Treatment

  Participant Flow
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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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Reporting Groups
  Description
Combined Photodynamic and Pulsed Dye Laser Treatment Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.

Participant Flow:   Overall Study
    Combined Photodynamic and Pulsed Dye Laser Treatment  
STARTED     17  
COMPLETED     16  
NOT COMPLETED     1  



  Baseline Characteristics
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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 Photodynamic and Pulsed Dye Laser Treatment Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.

Baseline Measures
    Combined Photodynamic and Pulsed Dye Laser Treatment  
Number of Participants  
[units: participants]
  17  
Age, Customized  
[units: participants]
 
Adult over 18     17  
Gender  
[units: participants]
 
Female     14  
Male     3  



  Outcome Measures

1.  Primary:   Blanching of Port Wine Stain Birthmark   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kristen M. Kelly, M.D.
Organization: University of California, Irvine
phone: 949-824-7103
e-mail: kmkelly@uci.edu



Responsible Party: Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00556946     History of Changes
Other Study ID Numbers: NIH/LAMMP-2003-3286
Study First Received: November 9, 2007
Results First Received: February 5, 2016
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration