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

Sponsor

University of California, Irvine (Other)

Overall Status

Recruiting

CT.gov ID

NCT01771718

Collaborator

Beckman Laser Institute University of California Irvine (Other)

200

Enrollment

Location

128

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. .

Condition or Disease	Intervention/Treatment	Phase
Skin Lesion	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Non-invasive Skin Imaging Using Multiphoton Microscopy

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

high-resolution images of skin [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beckman Laser Institute Medical Clinic	Irvine	California	United States	92612

Sponsors and Collaborators

University of California, Irvine
Beckman Laser Institute University of California Irvine

Investigators

Principal Investigator: Kristen Kelly, MD, Beckman Laser Institute, UCI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

NIH/LAMMP-2011-8494

First Posted:

Jan 18, 2013

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Study Results

No Results Posted as of Jan 12, 2021