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Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774552
First Posted: January 24, 2013
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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.

Condition Intervention
Port-wine Stain Device: Photo Acoustic Microscopy and Optical Coherence tomography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Photo Acoustic Microscopy and Optical Coherence Tomography Imaging Technologies to Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment.

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • evaluate the port-wine stain birthmark [ Time Frame: up to 12 months ]
    pulsed dye laser treatment


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Port-wine stain
Photo Acoustic Microscopy and Optical Coherence tomography
Device: Photo Acoustic Microscopy and Optical Coherence tomography
Photo Acoustic Microscopy and Optical Coherence tomography

Detailed Description:
The researchers at University of California, Irvine and Washington University in Saint Louis are collaborating in this project and developes new multiple imaging devices call photoacoustic microscopy and optical coherence tomography imaging technologies can be use to evaluate the response of port-wine stain from Pulse Dye Laser treatment.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from Beckman Laser Medical Clinic, UCI
Criteria

Inclusion Criteria:

  • All age with diagnosis of Port-wine stain

Exclusion Criteria:

  • No diagnosis of Port-wine stain
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774552


Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: Wangcun Jia, PhD         
Sub-Investigator: Stuart Nelson, MD, PhD         
Sub-Investigator: Bin Rao, PhD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Wancun Jia, PhD Beckman Laser Institute, UCI
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Wangcun Jia, PhD., Research Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01774552     History of Changes
Other Study ID Numbers: NIH/LAMMP-2012-9094
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases