NCT03535077

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 186 (actual)
• Sponsor: Orlucent, Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Lesion
• Melanoma (Skin)
• Mole

Interventions

Type	Name	Description
OTHER	Diagnostic Test	Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Timeline

• Start date: 2018-01-24
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-05-24
• Last updated: 2024-01-10

Locations

6 sites across 1 country: United States