Pathogenic Mechanisms of Port Wine Stain and Repository o... | NCT02051101

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

NCT02051101

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Port-Wine Stain

Interventions

Biopsy sample from Port Wine Stain Birthmark

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2013Actual

Primary Completion Date

Jan 11, 2019Actual

Completion Date

Jan 11, 2019Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Wenbin Tan, Ph.D. Project Scientist, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Port Wine Stain Birthmark	Other	Biopsy sample from Port Wine Stain Birthmark	Other: Biopsy sample from Port Wine Stain Birthmark

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy sample from Port Wine Stain Birthmark	Other	Biopsy sample from Port Wine Stain Birthmark	Port Wine Stain Birthmark

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterization of Port Wine Stain Birthmark tissue sample		up to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John s Nelson, MD	Beckman Laser Institute, UCI	Study Director
Winbin Tan, PhD	Beckman Laser Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute		Irvine	California	92612	United States

Condition Browse Module

MeSH Terms

ID	Term
D019339	Port-Wine Stain

Ancestor Terms

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided