NCT01771718

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2012Dec 2027

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

15.7 years

First QC Date

January 15, 2013

Last Update Submit

August 22, 2025

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Human skin

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

Device: Multiphoton microscopy-based tomograph.

Interventions

Multiphoton microscopy-based tomograph.DEVICE

non-invasive optical biopsy

Human skin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical Clinic

Irvine, California, 92612, United States

RECRUITING

Study Officials

  • Kristen Kelly, MD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Kim

CONTACT

949-824-2251hhkim3@uci.edu

Mihaela Balu, PhD

CONTACT

mbalu@uci.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Department of Dermatology

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 18, 2013

Study Start

April 1, 2012

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)