Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Onychomycosis Clinical Trial

Official title:

Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074315
• Other study ID #: CT002-02
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Nail Genesis LLC
• Contact: Brittany Ishmael
• Phone: 719 321 0876
• Email: brittany.ishmael[@]brightps.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

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).
• Nail Genesis DLSO Product (vehicle only)
The Nail Genesis DLSO product poly-urethane vehicle

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	Clinical Trials Institute of Northwest Arkansas	Fayetteville	Arkansas
United States	West Houston Clinical Research Service	Houston	Texas
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	Catalina Research Institute, LLC	Montclair	California
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	Northern California Research	Sacramento	California
United States	Metro Clinical Trials	San Bernardino	California
United States	Doctors Research Network	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nail Genesis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Week 48
Primary	Safety - Adverse Events	Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)	Week 48
Secondary	Almost complete cure	Proportion of subjects achieving almost Complete Cure (< 10% clinical involvement of the target toenail) in addition to Mycologic Cure.	Week 48
Secondary	Mycological Cure	Proportion of subjects achieving Mycologic Cure of the target toenail at Week 48	Week 48