Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
1 other identifier
interventional
338
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedDecember 8, 2023
December 1, 2023
1.3 years
October 2, 2023
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Safety - Adverse Events
Proportion of subjects with treatment-emergent AEs of Nail Genesis DLSO Product compared with vehicle control)
Week 48
Secondary Outcomes (2)
Almost complete cure
Week 48
Mycological Cure
Week 48
Study Arms (2)
Nail Genesis DLSO Product
EXPERIMENTALNail Genesis DLSO Product, poly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Vehicle
PLACEBO COMPARATORpoly(urea-urethane) in carrier solvents, applied topically, once daily, to target toenail.
Interventions
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).
The Nail Genesis DLSO product poly-urethane vehicle
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nail Genesis LLClead
Study Sites (10)
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, 72703, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Northern California Research
Sacramento, California, 95821, United States
Metro Clinical Trials
San Bernardino, California, 92404, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
DermResearch
Austin, Texas, 78759, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 10, 2023
Study Start
October 1, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
December 8, 2023
Record last verified: 2023-12