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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535077
• Other study ID #: SFI 001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Mole
• Skin Lesion

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