Personalized Interactive Laser Therapy of Port Wine Stain

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Port Wine Stain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

3D Digital Camera

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No