Clinical trial NCT03535077: Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)
Official title: Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesion
Melanoma (Skin)
Mole
Keywords: Melanoma
Nevus
Mole
Atypical Nevi
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 186
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc
state: California
city: Irvine
country: United States
facility: UCI Center for Clinical Research
state: California
city: Menlo Park
country: United States
facility: Divya Railan, Md, Faad
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Vallejo
country: United States
facility: Solano Dermatology Associates
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: President
name: Cathy Shachaf, PhD
role: STUDY_DIRECTOR
References: