NCT01774552

Brief Summary

Port-wine stain is a congenital, progressive vascular malformation of human skin involving post-capillary venules that occurs in an estimated 0.3% of children and can alter personality development and psychological in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

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

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

January 22, 2013

Last Update Submit

October 28, 2022

Conditions

Port-wine Stain

Outcome Measures

Primary Outcomes (1)

  • evaluate the port-wine stain birthmark

    pulsed dye laser treatment

    up to 12 months

Study Arms (1)

Port-wine stain

Photo Acoustic Microscopy and Optical Coherence tomography

Device: Photo Acoustic Microscopy and Optical Coherence tomography

Interventions

Photo Acoustic Microscopy and Optical Coherence tomographyDEVICE

Photo Acoustic Microscopy and Optical Coherence tomography

Port-wine stain

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be selected from Beckman Laser Medical Clinic, UCI

You may qualify if:

  • All age with diagnosis of Port-wine stain

You may not qualify if:

  • No diagnosis of Port-wine stain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Wancun Jia, PhD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wangcun Jia, PhD., Research Scientist

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

December 1, 2012

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)