Novel Treatment for Port Wine Stain Birthmarks

NCT ID: NCT01924273

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-07-03

Brief Summary

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

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.

Conditions

Port-Wine Stain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Port Wine Stain Birthmarks

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Group Type: OTHER

Talaporfin sodium

Intervention Type: DRUG

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Interventions

Talaporfin sodium

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Intervention Type: DRUG

Other Intervention Names

Combined Laser treatment andTalaporfin sodium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute

Locations

Beckman Laser Institute

Irvine, California, United States

Countries

United States

Other Identifiers

20139337

Identifier Type: -

Identifier Source: org_study_id