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

Completed

• Conditions: Mole; Skin Lesion; Melanoma (Skin)

• Registration Number: NCT03535077
• Lead Sponsor: Orlucent, Inc

Brief 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

Detailed Description

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

Study Timeline

• Study Start: 2018-01-24
• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-05-12
• Study First Posted: 2018-05-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Subjects with a pigmented skin lesion recommended for a skin biopsy.
2. 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.
3. At least 21 years old.
4. Written, signed, and dated informed consent
5. Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation	1 day	To identify histological features that correlate with the imaging features captured using SFI

Trial Locations

Locations (6)

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