Terbinafine Hydrochloride for the Treatment of Otomycosis (NCT07152327) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Terbinafine Hydrochloride for the Treatment of Otomycosis
50 participantsStarted 2025-10-01
Plain-language summary
Otomycosis is a fungal infection of the ear that often causes itching, pain, ear discharge, and hearing problems. It is more common in hot and humid climates and in people with risk factors such as diabetes, frequent use of antibiotic ear drops, or swimming in polluted water. Standard treatments include antifungal ear drops, but relapses are frequent.
This study will evaluate the effectiveness of terbinafine hydrochloride cream, an antifungal medication, in treating otomycosis. Terbinafine is known to be active against fungi such as Aspergillus and Candida, which are common causes of ear fungal infections. In this study, patients with otomycosis will have terbinafine hydrochloride cream applied on an ear pack that will be placed in the ear canal and changed every two days for two weeks.
The main goal of the study is to find out whether terbinafine hydrochloride is effective in reducing symptoms and eradicating the fungal infection. Patients will be examined clinically and ear swabs will be tested before and after treatment. The study will be conducted at Assiut University Hospital and Assiut General Hospital in Egypt, and about 50 patients are expected to participate.
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:
* Age ≥ 18 years (male or female).
Clinical diagnosis of otomycosis (presence of itching, ear discharge, ear canal debris, or fungal mass on otoscopic exam).
Confirmation of fungal infection by direct microscopy (KOH preparation) and/or culture.
Willingness to comply with study procedures and follow-up visits.
Provided written informed consent.
Exclusion Criteria:
* Age \< 18 years.
Bacterial otitis externa, mixed bacterial-fungal infection, or chronic suppurative otitis media.
History of ear surgery or tympanic membrane perforation.
Use of systemic or topical antifungal agents within the last 2 weeks.
Known hypersensitivity or allergy to terbinafine or excipients of the study drug.
Immunocompromised patients (e.g., HIV/AIDS, chemotherapy, uncontrolled diabetes mellitus).
Pregnant or breastfeeding women.
Patients unable or unwilling to provide informed consent or adhere to treatment protocol.
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.
What they're measuring
1
Clinical and mycological cure rate of otomycosis after topical terbinafine
Timeframe: 14 days (±3) from treatment initiation
2
Clinical and mycological cure rate of otomycosis after topical terbinafine