Safety and Efficacy of Next Science Gel on Toenail Fungus (NCT04042857) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of Next Science Gel on Toenail Fungus
United States20 participantsStarted 2019-07-26
Plain-language summary
This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.
Who can participate
Age range
18 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
. Ages 18 years old and above
. Established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail
. Positive culture for dermatophytes and positive potassium hydroxide examination
. Provide signed and dated informed consent
. Willing to comply with all study procedures and available for the duration of the study
Exclusion criteria
. Known allergic reaction to the study products
. Unable to provide signed and dated informed consent form
. Unable or unwilling to comply with all study procedures and/or unavailable for duration of the study
. Thickness of mycotic nail is greater than 3mm
. Less than 2mm of clear nail at the proximal aspect
. History of rheumatoid arthritis
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.