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

Skin Lesion Clinical Trial

Official title:

Non-invasive Skin Imaging Using Multiphoton Microscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771718
• Other study ID #: 20118494
• Secondary ID: R01EB026705
• Status: Recruiting
• Start date: April 2012
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of California, Irvine
• Contact: Hanna Kim, MA
• Phone: 949-824-9265
• Email: hhkim3[@]uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or Female all age groups

• Ability to understand and carry out subject instructions

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Skin Lesion

Intervention

Device:
• MPTflex-multiphoton microscopy-based tomograph.
non-invasive optical biopsy

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical Clinic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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