Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
Primary Purpose
Port-Wine Stain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy sample from Port Wine Stain Birthmark
Sponsored by
About this trial
This is an interventional basic science trial for Port-Wine Stain
Eligibility 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.
Sites / Locations
- Beckman Laser Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Port Wine Stain Birthmark
Arm Description
Biopsy sample from Port Wine Stain Birthmark
Outcomes
Primary Outcome Measures
Characterization of Port Wine Stain Birthmark tissue sample
Secondary Outcome Measures
Full Information
NCT ID
NCT02051101
First Posted
November 6, 2013
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
1. Study Identification
Unique Protocol Identification Number
NCT02051101
Brief Title
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
Official Title
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2013 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Port Wine Stain Birthmark
Arm Type
Other
Arm Description
Biopsy sample from Port Wine Stain Birthmark
Intervention Type
Other
Intervention Name(s)
Biopsy sample from Port Wine Stain Birthmark
Intervention Description
Biopsy sample from Port Wine Stain Birthmark
Primary Outcome Measure Information:
Title
Characterization of Port Wine Stain Birthmark tissue sample
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John s Nelson, MD
Organizational Affiliation
Beckman Laser Institute, UCI
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Winbin Tan, PhD
Organizational Affiliation
Beckman Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
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Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
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