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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of California, Irvine
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Kristen Kelly, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01771718
First received: January 15, 2013
Last updated: June 6, 2015
Last verified: June 2015
  Purpose

The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin for characterization of their morphologic and functional features. Currently, there is no standard non-invasive method for skin imaging.


Condition Intervention
Skin Lesion
Device: multiphoton microscopy.

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • non-cancer skin [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Multiphoton microscopy imaging to collect information about changes in skin cells and tissue


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 tissue
Device: multiphoton microscopy.
multiphoton microscopy.

Detailed Description:

Researchers developed a non-invasive multi photon microscopy instrument to image normal and lesional skin. Skin lesions can be imaged and evaluated using the multiphoton microscopy device imaging method and compared to standard of care processed skin biopsies.

Any biopsies will be performed by the health care provider as a standard of care procedure. The microscopy images obtained before biopsy will be compared with histopathology results.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 age 18 years of age or older
  • Has diagnose with skin pigmented lesion

Exclusion Criteria:

  • Minor and pregnant women
  • Has no pigmented lesion
  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: Montana Compton, RN 949-824-9265 mocomton@uci.edu
Contact: Mihaela Balu, PhD

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: Kristen Kelly, MD         
Sub-Investigator: Mihaela Balu, PhD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Christopher Zachary, MD         
Sub-Investigator: Tatiana Krasieva, PhD         
Sub-Investigator: Ataollah Sharif, MD         
Sub-Investigator: Viera Crosignani, PhD         
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

No publications provided

Responsible Party: 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, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 29, 2015