Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis (NCT06074315) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis
United States338 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.