Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborators:
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Information provided by (Responsible Party):
University of Arkansas

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.

Condition or disease Intervention/treatment Phase
Port Wine Stain Device: ThermoVision A20M Infrared Camera Device: ScleroPLUS Device: 3D Digital Camera Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
Study Start Date : October 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: ThermoVision A20M Infrared Camera
    FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
  • Device: ScleroPLUS
    Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.
  • Device: 3D Digital Camera
    3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with a PWS
  • At least one visible PWS measuring greater than or equal to 15 mm in diameter.
  • Information provided regarding alternative treatment methods, includig no treatment.
  • Reading, understanding, and signing of an informed consent document.
  • Children age 7 years or older has read, understood, and signed an assent document.
  • Agreement to participate in the study.
  • Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
  • Zubrod performance status of 0 or 1 at screening.

Exclusion Criteria:

  • Inability or unwillingness of subject to participate in the study.
  • Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
  • Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782483


Locations
Layout table for location information
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
Children's University Medical Group
Investigators
Layout table for investigator information
Principal Investigator: Gal Shafirstein, PhD UAMS, ACH
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00782483    
Other Study ID Numbers: 104344
UAMS Sponsored
First Posted: October 31, 2008    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014
Last Verified: June 2014
Keywords provided by University of Arkansas:
Diagnosis
Port Wine Stain
PWS
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemangioma, Capillary
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
 Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms