Novel Treatment for Port Wine Stain Birthmarks

NCT01924273 | Completed Phase 1 DMC

• 1 other identifier: 20139337
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Port-Wine Stain

Keywords

Port Wine Stain Birthmarks

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Port Wine Stain Birthmarks

OTHER

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Drug: Talaporfin sodium

Interventions

Talaporfin sodium DRUG

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Also known as: Combined Laser treatment andTalaporfin sodium

Port Wine Stain Birthmarks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/Female 18 years and older
• Have Port Wine Stain Birthmarks non-facial

You may not qualify if:

• Under 18 years of age
• No Port Wine Stain Birthmarks
• pregnant/breast feeding

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Talaporfin

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristen Kelly, MD

  Beckman Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: August 16, 2013
• Study Start: June 1, 2013
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)