NCT02473874

Brief Summary

The purpose of this study is to obtain skin spectroscopic data from two imaging systems. Comparison groups:

  • Skin Spect dermoscope
  • Spatially modulated quantitative spectrometer

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Start

First participant enrolled

June 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4.6 years

First QC Date

June 5, 2015

Last Update Submit

October 28, 2022

Conditions

Melanocytic Nevus

Outcome Measures

Primary Outcomes (1)

  • Changes in human skin structure

    Comparison Imaging Changes in human skin structure Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy

    up to 12 weeks

Study Arms (2)

Skin Spect dermoscope

Skin mole

Device: Skin Spect dermoscope

Spatially modulated quantitative

Skin mole

Device: Spatially modulated quantitative

Interventions

Skin Spect dermoscopeDEVICE

Skin imaging

Skin Spect dermoscope
Spatially modulated quantitativeDEVICE

Skin imaging

Spatially modulated quantitative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from an outpatient population of subjects at Beckman Laser Medical Clinic, University of California, Irvine.

You may qualify if:

  • Skin lesion a mole located on flat surface of the body

You may not qualify if:

  • Mole located on complex surface
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Nevus, Pigmented

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Kristen Kelly, MD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kristen Kelly, M.D., Professor of Dermatology and Surgery

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 17, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)