Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
NCT ID: NCT06074315
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
338 participants
INTERVENTIONAL
2023-10-01
2025-01-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nail Genesis DLSO Product
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Nail Genesis DLSO Product
Nail fungus is difficult to treat with topical drugs because of the thickness of the nails (Murdan, 2002). Nail Genesis DLSO Product does not contain a drug or antifungal agent and so is not designed to have a direct action on the microorganism, but instead will act by changing the conditions that allow growth of the fungus (i.e., keeping the nail plate and underlying nail bed dry and inhibiting secondary infection).
Vehicle
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Nail Genesis DLSO Product (vehicle only)
The Nail Genesis DLSO product poly-urethane vehicle
Interventions
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Nail Genesis DLSO Product
Nail fungus is difficult to treat with topical drugs because of the thickness of the nails (Murdan, 2002). Nail Genesis DLSO Product does not contain a drug or antifungal agent and so is not designed to have a direct action on the microorganism, but instead will act by changing the conditions that allow growth of the fungus (i.e., keeping the nail plate and underlying nail bed dry and inhibiting secondary infection).
Nail Genesis DLSO Product (vehicle only)
The Nail Genesis DLSO product poly-urethane vehicle
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Nail Genesis LLC
INDUSTRY
Responsible Party
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Locations
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Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, United States
Catalina Research Institute, LLC
Montclair, California, United States
Northern California Research
Sacramento, California, United States
Metro Clinical Trials
San Bernardino, California, United States
Doctors Research Network
South Miami, Florida, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
DermResearch
Austin, Texas, United States
West Houston Clinical Research Service
Houston, Texas, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Hillary Walker
Role: primary
Tim Dugan
Role: backup
Araselly Romero
Role: primary
Claudia Ramirez
Role: backup
Laurie Johnson
Role: primary
Araselly Romero
Role: primary
Claudia Ramirez
Role: backup
Patria Divison
Role: primary
Jenjira Skrei
Role: primary
Devon Taylor
Role: primary
Amanda Reed
Role: backup
Sasha Thompson
Role: primary
Braulio Suarez, MD
Role: primary
Bridgett Tweedy
Role: primary
Sue Foster
Role: backup
Other Identifiers
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CT002-02
Identifier Type: -
Identifier Source: org_study_id