The Validation of New Photographic Technology for Assessing Skin Lesions

Validation of New Photographic Technology for Assessing Skin Lesions

The purpose of this study is to determine the validity of a new photographic technology in a dermatologic setting. The digital picture uses high levels of resolution to look at skin biopsy lesions. These photos will be compared to current standard-of-care with hematoxylin and eosin histologic analysis by board-certified dermatologists.

Study Overview

• Status: Completed
• Conditions: Skin Lesions

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Wright State Physicians Dermatology Clinic

Description

Inclusion Criteria:

• Adult patients ages 18 and older.
• Able to comprehend procedures, risks, and informed consent.
• Have a skin lesion the practitioner believes, and subject agrees, should be biopsied.
• Lesion on a non-revealing part of the body (none on areas that would be recognizable, nor on groin nor breasts).
• Willingness of subject to share the results of the biopsy pathology.

Exclusion Criteria:

• Lesion on a revealing part of body.
• Unable to understand the procedures, informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of matching dermatologic diagnoses from photography to biopsied lesions.	A group of board-certified dermatologists will evaluate the standard digital vs. enhanced digital photograph of the lesion to compare the accuracy of diagnoses to the pathology report, with pathology serving as the gold standard.	At time of biopsy procedure of the lesion.

Collaborators and Investigators

• Sponsor: Wright State University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2022-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No