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

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ClinicalTrials.gov Identifier: NCT03535077
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : November 18, 2020
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Skin Lesion Melanoma (Skin) Mole Other: Diagnostic Test

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Group/Cohort Intervention/treatment
Suspicious Nevi undergoing biopsy
Subject with suspicious Nevi undergoing biopsy per SOC
Other: Diagnostic Test
Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy
Other Name: SFI 001 Imaging

Primary Outcome Measures :
  1. Correlation [ Time Frame: 1 day ]
    To identify histological features that correlate with the imaging features captured using SFI

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will enroll subjects being evaluated for suspicious moles/nevi and who will be scheduled to undergo a biopsy of the mole/nevus as part of the physicians standard plan of care.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535077

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Contact: Brandi Dunn Project Manager, RN 2107714024 brandi.dunn@orlucent.com

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United States, California
Center for Dermatology Clinical Research, Inc Completed
Fremont, California, United States, 94538
UCI Center for Clinical Research Recruiting
Irvine, California, United States, 92697
Contact: Kristen Kelly, MD         
Principal Investigator: Kristen Kelly, MD         
Divya Railan, Md, Faad Completed
Menlo Park, California, United States, 94025
The Menkes Clinic & Surgery Center Withdrawn
Mountain View, California, United States, 94040
Quest Dermatology Research Recruiting
Northridge, California, United States, 91324
Contact: Lawrence Osman, MD         
Principal Investigator: Lawrence Osman, MD         
Solano Dermatology Associates Completed
Vallejo, California, United States, 94590
United States, Utah
University of Utah Completed
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Orlucent, Inc
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Study Director: Cathy Shachaf, PhD President
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Responsible Party: Orlucent, Inc
ClinicalTrials.gov Identifier: NCT03535077    
Other Study ID Numbers: SFI 001
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orlucent, Inc:
Atypical Nevi
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas