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Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Primary Purpose

Distal Lateral Subungual Onychomycosis, Onychomycosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nail Genesis DLSO Product
Nail Genesis DLSO Product (vehicle only)
Sponsored by
Nail Genesis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Lateral Subungual Onychomycosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Trials Institute of Northwest Arkansas
  • Catalina Research Institute, LLCRecruiting
  • Northern California Research
  • Metro Clinical TrialsRecruiting
  • Doctors Research Network
  • Minnesota Clinical Study Center
  • Rochester Clinical Research, LLC
  • DermResearch
  • West Houston Clinical Research ServiceRecruiting
  • The Education & Research Foundation, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nail Genesis DLSO Product

Vehicle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effectiveness - Complete Cure
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).
Safety - Adverse Events
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2023
Last Updated
October 9, 2023
Sponsor
Nail Genesis LLC
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1. Study Identification

Unique Protocol Identification Number
NCT06074315
Brief Title
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
Official Title
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nail Genesis LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Lateral Subungual Onychomycosis, Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nail Genesis DLSO Product
Arm Type
Experimental
Arm Description
Nail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Intervention Type
Device
Intervention Name(s)
Nail Genesis DLSO Product
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Nail Genesis DLSO Product (vehicle only)
Intervention Description
The Nail Genesis DLSO product poly-urethane vehicle
Primary Outcome Measure Information:
Title
Effectiveness - Complete Cure
Description
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).
Time Frame
Week 48
Title
Safety - Adverse Events
Description
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Almost complete cure
Description
Proportion of subjects achieving almost Complete Cure (< 10% clinical involvement of the target toenail) in addition to Mycologic Cure.
Time Frame
Week 48
Title
Mycological Cure
Description
Proportion of subjects achieving Mycologic Cure of the target toenail at Week 48
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Ishmael
Phone
719 321 0876
Email
brittany.ishmael@brightps.com
Facility Information:
Facility Name
Clinical Trials Institute of Northwest Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hillary Walker
Phone
479-544-3483
Email
hwalker@ctinwa.com
First Name & Middle Initial & Last Name & Degree
Tim Dugan
Phone
501-655-6138
Email
tdugan@ctinwa.com
First Name & Middle Initial & Last Name & Degree
Rebekah Baltz, MD
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Araselly Romero
Phone
909-590-8409
Ext
237
Email
aromero@catalinari.com
First Name & Middle Initial & Last Name & Degree
Claudia Ramirez
Phone
9095906306
Email
cramirez@catalinari.com
First Name & Middle Initial & Last Name & Degree
Rizwana Mohseni, DO
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Johnson
Phone
916-484-0500
Email
ljohnson@norcare.net
First Name & Middle Initial & Last Name & Degree
Douglas Young, MD
Facility Name
Metro Clinical Trials
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Araselly Romero
Phone
909-590-8409
Email
aromero@catalinari.com
First Name & Middle Initial & Last Name & Degree
Claudia Ramirez
Phone
9095906306
Email
cramirez@catalinari.com
First Name & Middle Initial & Last Name & Degree
Cecilia Casaclang, MD
Facility Name
Doctors Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patria Divison
Phone
305-665-3017
Email
pdivison@drnmiami.com
First Name & Middle Initial & Last Name & Degree
Maria Surprenant, MD
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenjira Skrei
Phone
763-571-4200
Email
jskrei@associatedskincare.com
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devon Taylor
Phone
585-288-0890
Email
regulatory@rcrclinical.com
First Name & Middle Initial & Last Name & Degree
Amanda Reed
Phone
585-288-0890
Email
regulatory@rcrclinical.com
First Name & Middle Initial & Last Name & Degree
Manasi K Ladrigan, MD
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Thompson
Phone
512-349-9889
Email
regulatorydri@vial.com
First Name & Middle Initial & Last Name & Degree
Janet Dubois, MD
Facility Name
West Houston Clinical Research Service
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Braulio Suarez, MD
Phone
281-738-2642
Email
bsuarez@whcrs.com
First Name & Middle Initial & Last Name & Degree
Oscar De Valle, MD
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bridgett Tweedy
Phone
434-847-8400
Email
btweedy@educationandresearch.com
First Name & Middle Initial & Last Name & Degree
Sue Foster
Phone
434-857-8400
Email
sfoster@educationandresearch.com
First Name & Middle Initial & Last Name & Degree
Carrie Cobb, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

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