The Validation of New Photographic Technology for Assessing Skin Lesions

NCT06663241 | Completed

• 1 other identifier: IRB-2022-151
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Wright State Physicians Dermatology Clinic

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 29, 2024
• Study Start: February 15, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)