This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: February 8, 2017
Last verified: February 2017
Results First Received: 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide 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.
No text entered.

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
  Hide 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
No text entered.


  More Information
  Hide More Information

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: February 8, 2017