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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

About this trial

This is an interventional basic science trial for Port-Wine Stain

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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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