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Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of California, Irvine
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01771718
First received: January 15, 2013
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features. .

Condition Intervention
Skin Lesion
Device: MPTflex-multiphoton microscopy-based tomograph.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Non-invasive Skin Imaging Using Multiphoton Microscopy

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

Primary Outcome Measures:
  • high-resolution images of skin [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Human skin
Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure.
Device: MPTflex-multiphoton microscopy-based tomograph.
non-invasive optical biopsy

Detailed Description:

This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies.

Any biopsies will be performed by the health care provider as a standard of care procedure.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from University of California Irvine Medical Clinic
Criteria

Inclusion Criteria:

  • Male or Female all age groups
  • Ability to understand and carry out subject instructions

Exclusion Criteria:

  • Pregnant women
  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: NCT01771718

Contacts
Contact: Ata Sharif, MD 949 824 9265 sharifs@uci.edu
Contact: Mihaela Balu, PhD mbalu@uci.edu

Locations
United States, California
Beckman Laser Institute Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Ata Sharif, MD    949-824-9265    sharifs@uci.edu   
Principal Investigator: Kristen Kelly, MD         
Sub-Investigator: Mihaela Balu, PhD         
Sub-Investigator: Christopher Zachary, MD         
Sub-Investigator: Tatiana Krasieva, PhD         
Sub-Investigator: Ata Sharif, MD         
Sub-Investigator: Rolf Saager, PhD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute, UCI
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01771718     History of Changes
Other Study ID Numbers: NIH/LAMMP-2011-8494 
Study First Received: January 15, 2013
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2016