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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights
No Placebo-Only Group
Summary
The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
Eligible Conditions
- Mole
- Epithelial Dysplasia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Establish the performance of SFI
Secondary study objectives
To compare SFI to clinical diagnosis.
To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nevi undergoing biopsy per SOCExperimental Treatment1 Intervention
Subjects with Nevi who will as part of their standard of care, will undergo biopsy.
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Who is running the clinical trial?
Orlucent, IncLead Sponsor
6 Previous Clinical Trials
1,469 Total Patients Enrolled
Cathy Shachaf, PhDStudy DirectorPresident
2 Previous Clinical Trials
686 Total Patients Enrolled
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