Personalized Interactive Laser Therapy of Port Wine Stain

Port Wine Stain Clinical Trial

Official title:

Personalized Interactive Laser Therapy of Port Wine Stain - Study 2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00782483
• Other study ID #: 104344
• Secondary ID: UAMS Sponsored
• Status: Terminated
• Phase: N/A
• First received: October 29, 2008
• Last updated: June 19, 2014
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain
• Vascular Malformations

Intervention

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.
• 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.
• 3D Digital Camera
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	Arkansas Children's Hospital Research Institute, Children's University Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.	Three treatments up to one year, whichever is first