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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03535077
Other study ID # SFI 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2018
Est. completion date December 31, 2022

Study information

Verified date January 2024
Source Orlucent, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Diagnostic Test
Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Locations

Country Name City State
United States 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 University of Utah Salt Lake City Utah
United States Solano Dermatology Associates Vallejo California

Sponsors (1)

Lead Sponsor Collaborator
Orlucent, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation To identify histological features that correlate with the imaging features captured using SFI 1 day
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