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Completed

NCT Number: NCT03535077

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

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

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Key information

Conditions

Skin Lesion Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysplastic Nevus Syndrome Genetic Diseases, Inborn Melanoma Melanoma (Skin) Mole Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Dermatology Clinical Research, Inc, Fremont, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a pigmented skin lesion recommended for a skin biopsy.
  • 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.
  • At least 21 years old.
  • Written, signed, and dated informed consent
  • Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion criteria

  • Lesion is less than 1 centimeter from the eyes.
  • Lesion is on the palms of the hands or soles of the feet.
  • Mucosal lesion.
  • Ulcerated lesion.
  • Subject is pregnant or planning to become pregnant during the study period.
  • Patients who are mentally or physically unable to comply with all aspects of the study.
  • Any subject undergoing chemotherapy.
  • Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.

Treatment and study plan

Diagnostic Test

Other

Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Other names: SFI 001 Imaging

Primary outcomes

  1. Correlation

    Time frame: 1 day

    To identify histological features that correlate with the imaging features captured using SFI

Sponsors and collaborators

Lead sponsor

Orlucent, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 24, 2018
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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