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Novel Treatment for Port Wine Stain Birthmarks

NCT01924273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-11-01

No results posted yet for this study

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

Interventions

DRUG

Talaporfin sodium

Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium

Sponsors & Collaborators

  • Beckman Laser Institute University of California Irvine

    collaborator OTHER

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Kristen Kelly, MD · Beckman Laser Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-07-03
Completion
2017-07-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924273 on ClinicalTrials.gov