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

NCT ID: NCT01771718

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skin Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Human skin

Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure.

Multiphoton microscopy-based tomograph.

Intervention Type DEVICE

non-invasive optical biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multiphoton microscopy-based tomograph.

non-invasive optical biopsy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnant women
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristen Kelly

Professor and Chair, Department of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute, UCI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beckman Laser Institute Medical Clinic

Irvine, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hanna Kim

Role: CONTACT

949-824-2251

Mihaela Balu, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hanna Kim

Role: primary

949-824-2251

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01EB026705

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20118494

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Radio Frequency Coils Generic
NCT01633866 ACTIVE_NOT_RECRUITING
Photoscreening for Retinoblastoma
NCT04344652 WITHDRAWN NA