Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Description

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

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Study Overview

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Study Details

Study overview

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.

Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Condition
Distal Lateral Subungual Onychomycosis
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Clinical Trials Institute of Northwest Arkansas, Fayetteville, Arkansas, United States, 72703

Montclair

Catalina Research Institute, LLC, Montclair, California, United States, 91763

Sacramento

Northern California Research, Sacramento, California, United States, 95821

San Bernardino

Metro Clinical Trials, San Bernardino, California, United States, 92404

South Miami

Doctors Research Network, South Miami, Florida, United States, 33143

New Brighton

Minnesota Clinical Study Center, New Brighton, Minnesota, United States, 55112

Rochester

Rochester Clinical Research, LLC, Rochester, New York, United States, 14609

Austin

DermResearch, Austin, Texas, United States, 78759

Houston

West Houston Clinical Research Service, Houston, Texas, United States, 77055

Lynchburg

The Education & Research Foundation, Inc., Lynchburg, Virginia, United States, 24501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nail Genesis LLC,

Study Record Dates

2025-01