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Trial record 3 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

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

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ClinicalTrials.gov Identifier: NCT00556946
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : April 19, 2016
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Port Wine Stains
Intervention Drug: Combined Photodynamic & Pulsed Dye Laser Treatment
Enrollment 17

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combined Photodynamic and Pulsed Dye Laser Treatment
Hide Arm/Group Description Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
Period Title: Overall Study
Started 17
Completed 16
Not Completed 1
Arm/Group Title Combined Photodynamic and Pulsed Dye Laser Treatment
Hide Arm/Group Description Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Adult over 18 Number Analyzed 17 participants
17
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
14
  82.4%
Male
3
  17.6%
1.Primary Outcome
Title Blanching of Port Wine Stain Birthmark
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment of Port Wine Stains
Hide Arm/Group Description:

Treatment of Port Wine Stains

Treatment of Port Wine Stains: Treatment of Port Wine Stains

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
16
Time Frame Through the study up to 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment of Port Wine Stains
Hide Arm/Group Description

Treatment of Port Wine Stains

Treatment of Port Wine Stains: Treatment of Port Wine Stains

All-Cause Mortality
Treatment of Port Wine Stains
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment of Port Wine Stains
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment of Port Wine Stains
Affected / at Risk (%)
Total   0/17 (0.00%) 
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
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