What is the mechanism of action of this treatment?

Common treatments for fungal nail infections, such as the Nail Genesis DLSO Product, typically involve antifungal agents that target the fungal cell membrane. Topical treatments like ciclopirox and efinaconazole inhibit the synthesis of essential components of the fungal cell membrane, leading to cell death. Oral treatments, such as terbinafine and itraconazole, work systemically to achieve the same effect. These mechanisms are important for patients to understand because adherence to the prescribed treatment regimen is essential for effectively eradicating the infection and preventing recurrence.

What side effects are associated with this type of intervention?

Common treatments for fungal nail infections include oral antifungal medications such as terbinafine, itraconazole, and fluconazole, as well as topical antifungal treatments. Oral antifungals can cause side effects like gastrointestinal upset, headache, rash, and, in rare cases, liver toxicity and heart failure. Topical treatments generally have fewer systemic side effects but can cause local irritation, redness, and itching at the application site. It is important to monitor for these side effects and consult with a healthcare provider to manage any adverse reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for fungal nail infections (onychomycosis), including both topical and oral antifungal agents. Topical treatments such as efinaconazole (Jublia) and tavaborole (Kerydin) are applied directly to the affected toenail. Oral antifungal medications like terbinafine (Lamisil) and itraconazole (Sporanox) are also commonly used and have been shown to be effective in treating onychomycosis. These treatments work by targeting the fungal infection within the nail, similar to the approach being studied with the Nail Genesis DLSO Product.

What other types of research exist?

Promising alternatives to Nail Genesis DLSO Product for treating fungal nail infections include terbinafine 250 mg daily and itraconazole 200 mg daily. Terbinafine has demonstrated higher cure rates and better clinical outcomes compared to itraconazole. Sequential pulse therapy with itraconazole and terbinafine is another potential option.

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Device

Nail Genesis DLSO Product for Fungal Nail Infection

N/A

Recruiting

Research Sponsored by Nail Genesis LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is male or female, and 18 to 65 years of age, inclusive.

Subject must be physically able to reach toes to clean, trim, and apply product to the target toenail.

Must not have

Subject has any disease/condition that might cause toenail abnormalities or interfere with evaluation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here, but generally topical treatments can cause local reactions such as redness, itching, or irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are between the ages of 18 and 65, and identify as either male or female.

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You must possess the physical capability to bend and reach your toes in order to effectively groom, cut, and apply product to the desired toe nails.

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You are willing and able to return for further study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a medical condition that could affect the health of your toenails or make it difficult to assess them accurately.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness - Complete Cure

Safety - Adverse Events

Secondary study objectives

Almost complete cure

Mycological Cure

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for fungal nail infections, such as the Nail Genesis DLSO Product, typically involve antifungal agents that target the fungal cell membrane. Topical treatments like ciclopirox and efinaconazole inhibit the synthesis of essential components of the fungal cell membrane, leading to cell death. Oral treatments, such as terbinafine and itraconazole, work systemically to achieve the same effect. These mechanisms are important for patients to understand because adherence to the prescribed treatment regimen is essential for effectively eradicating the infection and preventing recurrence.