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

Last updated: January 9, 2024
Sponsor: Orlucent, Inc
Overall Status: Completed

Phase

N/A

Condition

Melanoma

Pressure Ulcer

Skin Cancer

Treatment

Diagnostic Test

Clinical Study ID

NCT03535077
SFI 001
  • Ages > 21
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 aroundthe 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

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 thestudy.
  7. Any subject undergoing chemotherapy.
  8. Any lesion that has been treated with local anesthesia such as lidocaine prior toenrollment that would confound study results.

Study Design

Total Participants: 186
Treatment Group(s): 1
Primary Treatment: Diagnostic Test
Phase:
Study Start date:
January 24, 2018
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Center for Dermatology Clinical Research, Inc

    Fremont, California 94538
    United States

    Site Not Available

  • UCI Center for Clinical Research

    Irvine, California 92697
    United States

    Site Not Available

  • Divya Railan, Md, Faad

    Menlo Park, California 94025
    United States

    Site Not Available

  • The Menkes Clinic & Surgery Center

    Mountain View, California 94040
    United States

    Site Not Available

  • Quest Dermatology Research

    Northridge, California 91324
    United States

    Site Not Available

  • Solano Dermatology Associates

    Vallejo, California 94590
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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