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Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02051101
First Posted: January 31, 2014
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.

Condition Intervention Phase
Port-Wine Stain Other: Biopsy sample from Port Wine Stain Birthmark Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Characterization of Port Wine Stain Birthmark tissue sample [ Time Frame: up to 4 weeks ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Port Wine Stain Birthmark
Biopsy sample from Port Wine Stain Birthmark
Other: Biopsy sample from Port Wine Stain Birthmark
Biopsy sample from Port Wine Stain Birthmark

Detailed Description:
The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female of all ages.
  • Not pregnant.
  • Has diagnosis of port wine stain on the arms, legs, chest, bac.
  • Ability to understand and carry out subject instructions.
  • Subject willing to have skin biopsies on port wine stain and normal skin areas.

Exclusion Criteria:

  • Pregnant women.
  • Port Wine Stain on the face.
  • History of skin cancer.
  • Current participation in an investigational drug evaluation
  • Concurrent use of known photosensitizing drugs.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051101


Contacts
Contact: Winbin Tan, PhD 310.819.0243 wenbintaine@gmail.com

Locations
United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Winbin Tan, PhD    310-819-0243    wenbintaine@gmail.com   
Sub-Investigator: John S Nelson, MD         
Principal Investigator: Winbin Tan, PhD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Study Director: John s Nelson, MD Beckman Laser Institute, UCI
Principal Investigator: Winbin Tan, PhD Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Wenbin Tan, Ph.D. Project Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02051101     History of Changes
Other Study ID Numbers: NIH/LAMMP-2013-9396
First Submitted: November 6, 2013
First Posted: January 31, 2014
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases