To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis (NCT05135910) | Clinical Trial Compass
UnknownPhase 2
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
United States35 participantsStarted 2022-01-13
Plain-language summary
The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).
Who can participate
Age range
18 Years – 75 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:
* Male and females 18 - 75 years of age inclusive
* Patients with DLSO of at least one great toe
* Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes
* Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period
Exclusion Criteria:
* History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
* Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
* Participation in another clinical study of an investigational drug or device within 3 months of screening
* No administration of oral terbinafine or another oral antifungal within 6 months of screening
* No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
* No uncontrolled diabetes mellitus
* No severe psoriasis or severe atopic dermatitis
Other protocol-defined inclusion/exclusion criteria may apply
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.