Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
- Conditions
- Distal Lateral Subungual OnychomycosisOnychomycosis
- Interventions
- Device: Nail Genesis DLSO Product (vehicle only)Device: Nail Genesis DLSO Product
- Registration Number
- NCT06074315
- Lead Sponsor
- Nail Genesis LLC
- Brief Summary
This is a Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail Genesis DLSO Product for the treatment of DLSO compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females between 18 and 65 years of age (inclusive). Subjects will be randomized in a 2:1 ratio to receive either Nail Genesis DLSO Product or vehicle.
Subject eligibility will be determined during a Screening assessment. Subjects will complete a 4week washout period after discontinuation of a topical product or a 12-month washout period after discontinuation of an oral product or light-based therapy prior to randomization. Eligible subjects will be randomized in a 2:1 ratio to receive Nail Genesis DLSO Product or vehicle, respectively. During the 52-week trial, study medication will be administered once daily to the target toenail for 48 weeks.
A subject will be considered to have completed the study when he or she has completed the study assessments at Week 52. The 52-week visit is for follow-up safety assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 338
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Nail Genesis DLSO Product (vehicle only) poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail. Nail Genesis DLSO Product Nail Genesis DLSO Product Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
- Primary Outcome Measures
Name Time Method Safety - Adverse Events Week 48 Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
Effectiveness - Complete Cure Week 48 Proportion of subjects with Complete Cure (0% involvement of the target toenail in addition to Mycologic Cure (defined as both negative KOH stain and negative dermatophyte culture).
- Secondary Outcome Measures
Name Time Method Almost complete cure Week 48 Proportion of subjects achieving almost Complete Cure (\< 10% clinical involvement of the target toenail) in addition to Mycologic Cure.
Mycological Cure Week 48 Proportion of subjects achieving Mycologic Cure of the target toenail at Week 48
Trial Locations
- Locations (10)
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Clinical Trials Institute of Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
Doctors Research Network
🇺🇸South Miami, Florida, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
West Houston Clinical Research Service
🇺🇸Houston, Texas, United States
The Education & Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Northern California Research
🇺🇸Sacramento, California, United States
DermResearch
🇺🇸Austin, Texas, United States
Metro Clinical Trials
🇺🇸San Bernardino, California, United States