Nail Genesis DLSO Product for Fungal Nail Infection

Recruiting at 9 trial locations

Overseen By Brittany Ishmael

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: Nail Genesis LLC

Must not be taking: Topical treatments, Oral treatments

Disqualifiers: Immunosuppression, Diabetes, Psoriasis, others

Compensation: Varies

Number of Visits: 2

Duration: 48 weeks

338 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new product, Nail Genesis DLSO, for treating fungal infections in the big toenail. Participants will apply either this product or a placebo (a substance with no active ingredient) daily for nearly a year. The trial seeks individuals with a fungal infection affecting 20-50% of their big toenail, excluding the white half-moon area near the cuticle. Participants must be able to reach their toes to clean and apply the product themselves. The study is particularly interested in those who have not recently used other nail fungus treatments. As an unphased trial, this study offers a unique opportunity to contribute to understanding new treatment options for nail fungus.

Will I have to stop taking my current medications?

Yes, if you are using any topical or oral treatments for nail conditions, you will need to stop them. There is a 4-week period without topical treatments and a 12-month period without oral treatments or light-based therapy before joining the trial.

What prior data suggests that the Nail Genesis DLSO Product is safe for treating fungal nail infections?

Research shows that specific safety information for the Nail Genesis DLSO Product in humans is not yet available. The product remains in early testing stages to assess its safety and effectiveness. At this point, researchers focus on ensuring the treatment is safe for use without major issues. If any serious risks or side effects emerge, the treatment will not proceed to the next stage. The product is applied to the skin, which typically presents fewer risks than oral or injectable treatments. Although specific data is not yet available, many skin-applied treatments are generally safe and only cause mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for fungal nail infections, like antifungal pills and medicated nail polishes, focus on killing the fungus or preventing its growth. But the Nail Genesis DLSO Product works differently. It uses a unique compound, poly(urea-urethane), which forms a protective barrier on the nail. This barrier not only targets the infection but also helps the nail heal and regrow in a healthier way. Researchers are excited about this treatment because it offers a novel approach that could potentially improve outcomes for patients struggling with persistent nail infections.

What evidence suggests that Nail Genesis DLSO Product might be an effective treatment for fungal nail infection?

This trial will compare the Nail Genesis DLSO Product with a vehicle-only version to assess their effectiveness in treating fungal nail infections. Research has shown that treatments like the Nail Genesis DLSO Product can help by eliminating the fungus and restoring nail health. Early results suggest that applying the Nail Genesis DLSO Product directly to the toenail might lead to a clinical cure, where the nail appears normal and shows no signs of infection. Although specific data on this product is limited, similar treatments have shown promise in reducing infection and improving nail appearance. The aim is to achieve a clear and healthy nail with consistent use over time. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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).

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Washout

Participants undergo a washout period after discontinuation of previous treatments

4 weeks for topical products, 12 months for oral products or light-based therapy

Treatment

Participants receive the study medication or vehicle control applied once daily to the target toenail

48 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at Week 52

What Are the Treatments Tested in This Trial?

Interventions

• Nail Genesis DLSO Product
• Nail Genesis DLSO Product (vehicle only)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Nail Genesis DLSO Product Experimental Treatment 1 Intervention

Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.

Group II: Vehicle Placebo Group 1 Intervention

poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.

Who Is Running the Clinical Trial?

Nail Genesis LLC

Lead Sponsor

Trials

1

Recruited

340+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06074315/evaluation-of-the-effectiveness-of-nail-genesis-dlso-product-for-onychomycosis

Evaluation of the Effectiveness of Nail Genesis DLSO ... This is a Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail ...

2. withpower.com withpower.com/trial/phase-onychomycosis-9-2023-f704f

Nail Genesis DLSO Product for Fungal Nail Infection This trial tests a new toenail treatment called Nail Genesis DLSO Product on adults with infected toenails. The treatment is applied regularly over several ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/364/toenail-fungus-onychomycosis

Toenail Fungus Onychomycosis Clinical Research Trials Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis. Phase. N/A. Span. 70 weeks. Sponsor. Nail Genesis LLC. Recruiting. READ MORE ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10941855/

Treatment Options for Onychomycosis: Efficacy, Side ... A clinical cure is defined as a normal nail without any evidence of fungal infection, which is the most important outcome for patients. The mycological cure ...

5. clinconnect.io clinconnect.io/trials/NCT02546258

Evaluation of the Performance of a Fungal Nail Treatment This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of ...

6. nail-genesis.com nail-genesis.com/

Nail Genesis Nail Genesis's product is a proven topical polymer that demonstrated high efficacy in a feasibility study. The onychomycosis market is growing at almost 10% ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0000154

Onychomycosis (DBCOND0000154) Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis ... A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail ...