Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

December 6, 2023 updated by: Nail Genesis LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Clinical Trials Institute of Northwest Arkansas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rebekah Baltz, MD
    • California
      • Montclair, California, United States, 91763
        • Recruiting
        • Catalina Research Institute, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rizwana Mohseni, DO
      • Sacramento, California, United States, 95821
        • Recruiting
        • Northern California Research
        • Contact:
        • Principal Investigator:
          • Douglas Young, MD
      • San Bernardino, California, United States, 92404
        • Recruiting
        • Metro Clinical Trials
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cecilia Casaclang, MD
    • Florida
      • South Miami, Florida, United States, 33143
        • Recruiting
        • Doctors Research Network
        • Contact:
        • Principal Investigator:
          • Maria Surprenant, MD
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Not yet recruiting
        • Minnesota Clinical Study Center
        • Principal Investigator:
          • Steven Kempers, MD
        • Contact:
    • New York
      • Rochester, New York, United States, 14609
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • DermResearch
        • Principal Investigator:
          • Janet Dubois, MD
        • Contact:
      • Houston, Texas, United States, 77055
        • Recruiting
        • West Houston Clinical Research Service
        • Contact:
        • Principal Investigator:
          • Oscar De Valle, MD
    • Virginia

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nail Genesis DLSO Product
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Device: 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).
Placebo Comparator: Vehicle
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Device: Nail Genesis DLSO Product (vehicle only)
The Nail Genesis DLSO product poly-urethane vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness - Complete Cure
Time Frame: 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).
Week 48
Safety - Adverse Events
Time Frame: Week 48
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Almost complete cure
Time Frame: Week 48
Proportion of subjects achieving almost Complete Cure (< 10% clinical involvement of the target toenail) in addition to Mycologic Cure.
Week 48
Mycological Cure
Time Frame: Week 48
Proportion of subjects achieving Mycologic Cure of the target toenail at Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nail Genesis LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT002-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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