Melanoma (Skin) Clinical Trial
Official title:
Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
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 |
Verified date | January 2024 |
Source | Orlucent, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Orlucent, Inc |
United States,
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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