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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556946
First Posted: November 12, 2007
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
Results First Submitted: February 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age, Customized 
[Units: Participants]
 
Adult over 18   17 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  82.4% 
Male      3  17.6% 


  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
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: February 5, 2016
Results First Posted: April 19, 2016
Last Update Posted: March 17, 2017