Status:
UNKNOWN
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
Lead Sponsor:
Nail Genesis LLC
Conditions:
Distal Lateral Subungual Onychomycosis
Onychomycosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT06074315
Start Date
October 1 2023
End Date
January 1 2025
Last Update
December 8 2023
Active Locations (10)
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1
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, United States, 72703
2
Catalina Research Institute, LLC
Montclair, California, United States, 91763
3
Northern California Research
Sacramento, California, United States, 95821
4
Metro Clinical Trials
San Bernardino, California, United States, 92404