Recruiting

Nail GenesisEvaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Sponsor:

Nail Genesis LLC

Code:

NCT06074315

Conditions

Distal Lateral Subungual Onychomycosis

Onychomycosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Nail Genesis DLSO Product

Nail Genesis DLSO Product (vehicle only)

Study Details

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.

Conditions

Distal Lateral Subungual Onychomycosis

Onychomycosis

Study ID

NCT06074315

Start date

Oct 1, 2023

Status verified date

Dec, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

338 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nail Genesis DLSO Product

Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.

placebo comparator: Vehicle

poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.

Interventions

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

Primary outcome measure

Effectiveness - Complete Cure [ Time Frame: Week 48 ]
Safety - Adverse Events [ Time Frame: Week 48 ]

Central Contacts and Locations

Central contacts

Brittany Ishmael

719 321 0876 brittany.ishmael@brightps.com

Locations

Clinical Trials Institute of Northwest Arkansas

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Hillary Walker

479-544-3483 hwalker@ctinwa.com

Tim Dugan

501-655-6138 tdugan@ctinwa.com

Principal Investigator:

Rebekah Baltz, MD

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Araselly Romero

909-590-8409 aromero@catalinari.com

Claudia Ramirez

9095906306 cramirez@catalinari.com

Principal Investigator:

Rizwana Mohseni, DO

Northern California Research

Recruiting

Sacramento, California, United States, 95821

Contacts

Laurie Johnson

916-484-0500 ljohnson@norcare.net

Principal Investigator:

Douglas Young, MD

Metro Clinical Trials

Recruiting

San Bernardino, California, United States, 92404

Contacts

Araselly Romero

909-590-8409 aromero@catalinari.com

Claudia Ramirez

9095906306 cramirez@catalinari.com

Principal Investigator:

Cecilia Casaclang, MD

Doctors Research Network

Recruiting

South Miami, Florida, United States, 33143

Contacts

Patria Divison

305-665-3017 pdivison@drnmiami.com

Principal Investigator:

Maria Surprenant, MD

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Contacts

Devon Taylor

585-288-0890 regulatory@rcrclinical.com

Amanda Reed

585-288-0890 regulatory@rcrclinical.com

Principal Investigator:

Manasi K Ladrigan, MD

DermResearch

Recruiting

Austin, Texas, United States, 78759

Contacts

Sasha Thompson

512-349-9889 regulatorydri@vial.com

Principal Investigator:

Janet Dubois, MD

West Houston Clinical Research Service

Recruiting

Houston, Texas, United States, 77055

Contacts

Braulio Suarez, MD

281-738-2642 bsuarez@whcrs.com

Principal Investigator:

Oscar De Valle, MD

The Education & Research Foundation, Inc.

Recruiting

Lynchburg, Virginia, United States, 24501

Contacts

Bridgett Tweedy

434-847-8400 btweedy@educationandresearch.com

Sue Foster

434-857-8400 sfoster@educationandresearch.com

Principal Investigator:

Carrie Cobb, MD

More Information

Sponsor

Nail Genesis LLC

Last update posted

Dec 8, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nail Genesis LLC on 2023-12-08.