NCT02051101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5.7 years

First QC Date

November 6, 2013

Last Update Submit

October 28, 2022

Conditions

Port-Wine Stain

Outcome Measures

Primary Outcomes (1)

  • Characterization of Port Wine Stain Birthmark tissue sample

    up to 4 weeks

Study Arms (1)

Port Wine Stain Birthmark

OTHER

Biopsy sample from Port Wine Stain Birthmark

Other: Biopsy sample from Port Wine Stain Birthmark

Interventions

Biopsy sample from Port Wine Stain BirthmarkOTHER

Biopsy sample from Port Wine Stain Birthmark

Port Wine Stain Birthmark

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John s Nelson, MD

    Beckman Laser Institute, UCI

    STUDY DIRECTOR

  • Winbin Tan, PhD

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wenbin Tan, Ph.D. Project Scientist

Study Record Dates

First Submitted

November 6, 2013

First Posted

January 31, 2014

Study Start

April 23, 2013

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)