CompletedNot Applicable

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

United States186 participantsStarted 2018-01-24

Plain-language summary

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

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Correlation

Timeframe: 1 day

Trial details

NCT IDNCT03535077

SponsorOrlucent, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-31

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