- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051101
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Port Wine Stain Birthmark
Biopsy sample from Port Wine Stain Birthmark
|
Biopsy sample from Port Wine Stain Birthmark
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterization of Port Wine Stain Birthmark tissue sample
Time Frame: up to 4 weeks
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: John s Nelson, MD, Beckman Laser Institute, UCI
- Principal Investigator: Winbin Tan, PhD, Beckman Laser Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 23, 2013
Primary Completion (ACTUAL)
January 11, 2019
Study Completion (ACTUAL)
January 11, 2019
Study Registration Dates
First Submitted
November 6, 2013
First Submitted That Met QC Criteria
January 29, 2014
First Posted (ESTIMATE)
January 31, 2014
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20139396
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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