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

Non-invasive Skin Imaging Using Multiphoton Microscopy

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. .

Study Overview

• Status: Recruiting
• Conditions: Skin Lesion
• Intervention / Treatment: Device: MPTflex-multiphoton microscopy-based tomograph.

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Mihaela Balu, PhD; Email: mbalu@uci.edu
• Study Contact Backup: Name: Hanna Kim, MA; Phone Number: 949-824-9265; Email: hhkim3@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Recruiting
      • Beckman Laser Institute Medical Clinic
      • Sub-Investigator: Christopher Zachary, MD
      • Contact: Hanna Kim, MA; Phone Number: 949-824-9265; Email: hhkim3@uci.edu
      • Sub-Investigator: Mihaela Balu, PhD
      • Principal Investigator: Kristen Kelly, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from University of California Irvine Medical Clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high-resolution images of skin	The complementary imaging modalities (MPM, MI) will provide insights into a better understanding of the relationship between microscopic and macroscopic properties of the skin.	up to 12 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Kristen Kelly, MD, Beckman Laser Institute, UCI

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimated): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20118494; R01EB026705 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No