Evaluating a new treatment for toenail fungus
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
This study is testing a new product to see if it can effectively treat toenail fungus in adults aged 18 to 65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Nail Genesis LLC Industry-sponsored |
| Locations | 10 sites (Fayetteville, Arkansas and 9 other locations) |
| Trial ID | NCT06074315 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and effectiveness of the Nail Genesis DLSO Product for treating distal lateral subungual onychomycosis in infected great toenails. It is a multicenter, randomized, double-blind, vehicle-controlled study involving 338 participants aged 18 to 65. Participants will be randomly assigned to receive either the Nail Genesis product or a placebo vehicle for 48 weeks, with a focus on measuring the treatment's impact on nail fungal infections. A washout period is required before randomization to ensure participants are free from other topical or oral treatments.
Who should consider this trial
Good fit: Ideal candidates are males and non-pregnant, non-lactating females aged 18 to 65 with a fungal infection affecting their great toenail.
Not a fit: Patients with severe nail matrix involvement or those unable to apply the product to their toenails may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective solution for patients suffering from toenail fungus, improving nail health and quality of life.
How similar studies have performed: While similar studies have been conducted, the specific approach of using the Nail Genesis DLSO Product is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is male or female, and 18 to 65 years of age, inclusive. * Subject has nail fungal infection of at least one great toenail (per visual assessment, positive KOH preparation, and positive dermatophyte culture). * 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 target toenail thickness of 3 mm or less. * Subject must be physically able to reach toes to clean, trim, and apply product to the target toenail. * Subject is willing and available to return for study follow up. * Subject or legal representative is able to understand and provide signed consent for participating in the study. * Female subject of childbearing potential has negative urine pregnancy test. * Females must be post-menopausal or must agree to use approved contraceptives (actions, de- vices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (abstinence is NOT an accepted form of contraception). Exclusion Criteria: * Subject has known hypersensitivity or allergy to the product materials. * Subject has negative KOH preparation or dermatophyte culture. * Subject has dermatophytoma on target toenail. * Subject is enrolled in another investigational drug, device, or product protocol that would interfere with this study. * Subject is using other topical or pharmaceutical treatments for any nail conditions; a wash-out period of at least four weeks after discontinuation of a topical product or 12 months after discontinuation of an oral product or light-based therapy for treatment of nail fungus is required. * Subject has history of immunosuppression and/or clinical signs indicative of possible immunosuppression. * 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 presence of toenail infection other than dermatophytes on target toenail. * Subject has any disease/condition that might cause toenail abnormalities or interfere with evaluation. * Subject has had previous toenail surgery on target toenail. * Subject is a pregnant or nursing female. * Subject is an Investigator, Nail Genesis' personnel, or Nail Genesis' Scientific Advisory Board (SAB) members, or their immediate family.
Where this trial is running
Fayetteville, Arkansas and 9 other locations
- Clinical Trials Institute of Northwest Arkansas — Fayetteville, Arkansas, United States (Recruiting)
- Catalina Research Institute, LLC — Montclair, California, United States (Recruiting)
- Northern California Research — Sacramento, California, United States (Recruiting)
- Metro Clinical Trials — San Bernardino, California, United States (Recruiting)
- Doctors Research Network — South Miami, Florida, United States (Recruiting)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (Not_yet_recruiting)
- Rochester Clinical Research, LLC — Rochester, New York, United States (Recruiting)
- DermResearch — Austin, Texas, United States (Recruiting)
- West Houston Clinical Research Service — Houston, Texas, United States (Recruiting)
- The Education & Research Foundation, Inc. — Lynchburg, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Brittany Ishmael
- Email: brittany.ishmael@brightps.com
- Phone: 719 321 0876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.