The Validation of New Photographic Technology for Assessing Skin Lesions

NCT06663241 — Completed, 200 participants, Wright State University

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Validation of New Photographic Technology for Assessing Skin Lesions

Registry	NCT06663241
Status	Completed
Study type	Observational
Enrollment	200 (Actual)
Sponsor	Wright State University (Other)
Conditions	Skin Lesions
Dates	start 2023-02-15, primary completion 2023-12-20, completion 2023-12-20, first posted 2024-10-29, last updated 2025-02-06
Locations	1 site in United States

-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.

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+Outcome measures

Primary outcomes

Number of matching dermatologic diagnoses from photography to biopsied lesions. [At time of biopsy procedure of the lesion.]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Wright State Physicians	Fairborn, Ohio	United States