Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Kristen Kelly, MD

Description

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

Official Title

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

Details

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.

Keywords

Skin Lesion Melanoma (Skin) Mole Melanoma Nevus Atypical Nevi Diagnostic Test Suspicious Nevi undergoing biopsy

Eligibility

You can join if…

Open to people ages 21 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UCI Center for Clinical Research accepting new patients
    Irvine California 92697 United States
  • Quest Dermatology Research accepting new patients
    Northridge California 91324 United States

Lead Scientist at UC Irvine

  • Kristen Kelly, MD
    Professor, Dermatology, School of Medicine. Authored (or co-authored) 120 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Orlucent, Inc
ID
NCT03535077
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated