Personalized Interactive Laser Therapy of Port Wine Stain

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. Identifier: NCT00782483
Recruitment Status : Terminated (PI moved out of state.)
First Posted : October 31, 2008
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Information provided by (Responsible Party):
University of Arkansas

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Port Wine Stain
Interventions: Device: ThermoVision A20M Infrared Camera
Device: ScleroPLUS
Device: 3D Digital Camera

  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
Laser Therapy Total number of participants

Participant Flow:   Overall Study
    Laser Therapy
STARTED   6 [1] 
Early Termination of Protocol - PI Reloc                6 
[1] 6 subjects enrolled beginning on 04/27/2009 with last enrollment on 04/13/2010.

  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
Overall Overall Study Group

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   1 
Between 18 and 65 years   5 
>=65 years   0 
[Units: Participants]
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   6 

  Outcome Measures

1.  Primary:   Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.   [ Time Frame: Three treatments up to one year, whichever is first ]

  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
PI relocated and protocol was terminated, and no subject returned for treatment under protocol.

  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: Dr. Gal Shafirstein
Organization: University of Arkansas for Medical Sciences/Arkansas Children's Hospital
phone: 501-364-7546

Responsible Party: University of Arkansas Identifier: NCT00782483     History of Changes
Other Study ID Numbers: 104344
UAMS Sponsored
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: January 6, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014