Novel Treatment for Port Wine Stain Birthmarks

Study Overview
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Brief Summary
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Port wine stains Birthmark are congenital, progressive vascular malformations of the skin that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of these malformations occur on the face. Personality development of virtually all patients is adversely affected as a result of the negative reaction of others to a marked person. Detailed studies have documented lower self-esteem and difficulties with interpersonal interactions in Port wine stains patients. Port wine stains are initially flat and red, but with time, they tend to darken to purple and become thickened as vascular nodules develop. This thickening occurs in approximately two-thirds of lesions and further disfigures the facial features of many patients.

Detailed Description
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Pulsed dye laser is currently the standard of care treatment for Port wine stains. Researchers at University of California Irvine at Beckman Laser Institute Medical Clinic can use Photodynamic therapy, another treatment option for Port wine stains. Photodynamic therapy involves light activation of a photosensitizer (a drug that is responsive to light or radiant energy). Because the photosensitizer can be localized to a desired portion of the Port wine stain, Photodynamic therapy creates an opportunity for targeted destruction of Port wine stains. Researchers will use a photosensitizer medication called Talaporfin sodium, an intravenously administered investigational photosensitizer, being evaluated for multiple clinical indications. Photodynamic therapy with talaporfin sodium has been investigated for many different conditions, and can be used for treatment for Port wine stains. Photosensitivity precaution instructions will be provided, including appropriate photo protective clothing, protective hat and sunglasses that wrap around the temples to help minimize lateral sun light exposure when traveling home following discharge from the study site. For efficacy, evaluated study variable will be Port wine stain blanching, and the researchers can use diffuse reflectance imaging chromametry, Laser Speckle Imaging and Spatial Frequency Domain Imaging to measure the change of Port wine stain blanching. The maximum power of the Laser Speckle Imaging and Spatial Frequency Domain Imaging light source is 10-50 mW, which is comparable to halogen-bulb household flashlights. Efficacy will be evaluated based on comparison of pre-treatment visit and post treatment day 1, week 1, week 4, and week 12 measurements.

Official Title
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Novel Treatment for Port Wine Stain Birthmarks

Conditions
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Port-Wine Stain

Intervention / Treatment
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* Drug: Talaporfin sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/Female 18 years and older Have Port Wine Stain Birthmarks non-facial Exclusion Criteria: Under 18 years of age No Port Wine Stain Birthmarks pregnant/breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Port Wine Stain Birthmarks<br>Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium | Drug: Talaporfin sodium<br>* Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium<br>* Other names: Combined Laser treatment andTalaporfin sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Port wine stain blanching | The outcome measure will be PWS blanching as assessed by Diffuse Reflectance Imaging/Laser Speckle Imaging/Spatial Frequency Domain Imaging. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Port Wine Stain Birthmarks