Skin LesionNCT03535077
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)
An observational study of Skin Lesion and Melanoma (Skin), run by Orlucent, Inc at 6 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Skin Lesion, Melanoma (Skin), Mole
- What is being tested?
- Diagnostic Test
- How many people
- 186 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
UCI Center for Clinical Research
Irvine, California, 92697
Divya Railan, Md, Faad
Menlo Park, California, 94025
Quest Dermatology Research
Northridge, California, 91324
University of Utah
Salt Lake City, Utah, 84112
Solano Dermatology Associates
Vallejo, California, 94590
About this study
Official title: Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin
Read the 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.
- Conditions
- Skin Lesion, Melanoma (Skin), Mole
- Being tested
- Diagnostic Test
- Keywords
- Melanoma, Nevus, Mole, Atypical Nevi
- Medical subject headings
- Melanoma, Nevus, Dysplastic Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestOther
Also called SFI 001 Imaging
Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy
| Study group | Role | What they receive |
|---|---|---|
| Suspicious Nevi undergoing biopsy | Subject with suspicious Nevi undergoing biopsy per SOC Receives: Other: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
To identify histological features that correlate with the imaging features captured using SFI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start24 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlucent, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cathy Shachaf, PhD, Study director, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535077
- Sponsor's protocol ID
- SFI 001
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2018
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)
- ClinicalTrials.gov ID
- NCT03535077
- Acronym / sponsor ID
- SFI 001
- Conditions
- Skin Lesion, Melanoma (Skin), Mole
- Keywords
- Melanoma, Nevus, Mole, Atypical Nevi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Orlucent, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicious Nevi undergoing biopsy | – | Other: Diagnostic TestSubject with suspicious Nevi undergoing biopsy per SOC |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestAlso: SFI 001 ImagingImaging of the suspicious lesion after application of ORL-1 dye prior to biopsy | Other | Suspicious Nevi undergoing biopsy |
Primary outcome
Correlation
Time frame: 1 day
To identify histological features that correlate with the imaging features captured using SFI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Shachaf, PhD study director
President
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesion and Melanoma (Skin), run by Orlucent, Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.