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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01774552
First received: January 22, 2013
Last updated: November 18, 2014
Last verified: November 2014
  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.

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • evaluate the port-wine stain birthmark [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774552

Locations
United States, California
Beckman Laser Institute Medical Clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Wancun Jia, PhD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01774552     History of Changes
Other Study ID Numbers: NIH/LAMMP-2012-9094
Study First Received: January 22, 2013
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014