Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Launched by NAIL GENESIS LLC · Oct 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a product called Nail Genesis DLSO, which is being tested to see how effective it is for treating a fungal infection in the toenails known as Distal Lateral Subungual Onychomycosis. The trial will involve 338 participants, both men and women aged 18 to 65, who have a fungal infection in at least one of their big toenails. To be eligible, participants need to have a specific level of infection and thickness in their toenail, and they must be able to apply the treatment themselves.

If you decide to participate, you will be randomly assigned to receive either the Nail Genesis product or a placebo (which looks the same but contains no active ingredients) for 48 weeks. You'll need to apply the treatment to your toenail once a day and return for follow-up appointments to monitor your progress and safety. The study is currently recruiting participants, and it’s important to note that certain health conditions or recent treatments may disqualify potential candidates. Your involvement in this trial could help researchers understand how well this new treatment works for toenail fungus.

Gender

ALL

Eligibility 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.