Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)

Completed

Conditions studied: Skin Lesion, Melanoma (Skin), Mole

In brief

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

Key facts

Study ID: NCT03535077
Run by: Orlucent, Inc
People needed: 186
Starts: 2018-01-24
Expected to finish: 2022-12-31
Last updated by the study team: 2024-01-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with a pigmented skin lesion recommended for a skin biopsy.
A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
At least 21 years old.
Written, signed, and dated informed consent
Scheduled for a primary excision/biopsy as part of the clinics SOC.

You may not qualify if…

Lesion is less than 1 centimeter from the eyes.
Lesion is on the palms of the hands or soles of the feet.
Mucosal lesion.
Ulcerated lesion.
Subject is pregnant or planning to become pregnant during the study period.
Patients who are mentally or physically unable to comply with all aspects of the study.
Any subject undergoing chemotherapy.
Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.

Where it is running

Center for Dermatology Clinical Research, Inc — Fremont, California, United States
UCI Center for Clinical Research — Irvine, California, United States
Divya Railan, Md, Faad — Menlo Park, California, United States
Quest Dermatology Research — Northridge, California, United States
Solano Dermatology Associates — Vallejo, California, United States
University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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