Pilot Study on In-vivo Non-invasive Skin Imaging Using Mu... | NCT01771718

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

NCT01771718

Sponsor

University of California, Irvine

Status

Recruiting

Last Update Posted

Aug 29, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Skin Lesion

Interventions

Multiphoton microscopy-based tomograph.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01EB026705	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jan 15, 2013

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2025

Last Update Posted Date

Aug 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristen Kelly, Professor and Chair, Department of Dermatology, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
National Institute for Biomedical Imaging and Bioengineering (NIBIB)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) and a MPM imaging system developed at BLI: Fast Large Area Multiphoton Exoscope (FLAME) 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human skin		Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure.	Device: Multiphoton microscopy-based tomograph.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multiphoton microscopy-based tomograph.	Device	non-invasive optical biopsy	Human skin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hanna Kim	Contact	949-824-2251		hhkim3@uci.edu
Mihaela Balu, PhD	Contact			mbalu@uci.edu

Overall Officials

Name	Affiliation	Role
Kristen Kelly, MD	Beckman Laser Institute, UCI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute Medical Clinic	Recruiting	Irvine	California	92612	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided