Nail Genesis DLSO Product for Fungal Nail Infection
Recruiting at 9 trial locations
MS
JC
BI
BI
Overseen ByBrittany Ishmael
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nail Genesis LLC
Trial Summary
What is the purpose of this trial?
This trial tests a new toenail treatment called Nail Genesis DLSO Product on adults with infected toenails. The treatment is applied regularly over several months. The goal is to see if it works effectively.
Eligibility Criteria
This trial is for adults aged 18-65 with a fungal infection in at least one great toenail, but without severe underlying conditions like diabetes or immune deficiencies. Participants must not be pregnant or nursing and should agree to use contraception. They must have stopped any other nail treatments for specific periods before the trial.Inclusion Criteria
Subject has target toenail showing 20-50% involvement without matrix (lunula) involvement.
Subject has 3 mm of unaffected nail (from proximal nail fold) on target toenail.
Subject has nail fungal infection of at least one great toenail (per visual assessment, positive KOH preparation, and positive dermatophyte culture).
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Exclusion Criteria
Subject with possible chronic disease, including: diabetes, psoriasis, immune deficiency (HIV), severe foot injury, chronic vascular disease, or in which delayed treatment (approved treatment) of DLSO for one year could present a significant health concern.
Subject has negative KOH preparation or dermatophyte culture.
Subject is enrolled in another investigational drug, device, or product protocol that would interfere with this study.
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Treatment Details
Interventions
- Nail Genesis DLSO Product (Device)
- Nail Genesis DLSO Product (vehicle only) (Device)
Trial OverviewThe study tests Nail Genesis DLSO Product against a non-medicated version (vehicle) to treat toenail fungus. It's randomized, meaning people are put into two groups by chance, with more receiving the actual product than the vehicle, and it's double-blind so neither participants nor researchers know who gets which treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nail Genesis DLSO ProductExperimental Treatment1 Intervention
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Group II: VehiclePlacebo Group1 Intervention
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
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Who Is Running the Clinical Trial?
Nail Genesis LLC
Lead Sponsor
Trials
1
Recruited
340+