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

Trial Summary

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.

Is the Nail Genesis DLSO Product safe for human use?

There is no specific safety data available for the Nail Genesis DLSO Product in the provided research articles. ^{1 2 3 4 5}

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).

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Oral nail growth supplements: a comprehensive review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of luliconazole 5% nail solution for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Safety Concerns of Skin, Hair and Nail Supplements in Retail Stores. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Side effects of nail cosmetics. [2006]

5. Italy pubmed.ncbi.nlm.nih.gov

New formulation for topical treatment of onychomycoses. [2018]