An interventional study of Terbinafine Hydrochloride Cream in Otomycosis and Fungal Ear Infection, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
Otomycosis is a common fungal infection of the external auditory canal. It is often associated with itching, ear blockage, tinnitus, pain, and hearing loss. Diagnosis is made clinically and confirmed by the presence of fungal growth on culture. Aspergillus species are the most frequent pathogens, but Candida species are also common.
Terbinafine hydrochloride is an antifungal drug from the allylamine class. It acts by inhibiting squalene epoxidase, an enzyme necessary for fungal cell membrane synthesis. Although terbinafine is not the first-line treatment for otomycosis, laboratory studies have shown it to be effective against Aspergillus and Candida, suggesting a potential role in therapy.
This single-arm, interventional clinical trial will include 50 patients diagnosed with otomycosis. Eligible participants will undergo full history and otoscopic examination. Ear swabs will be obtained before and after treatment for fungal culture. The intervention consists of applying terbinafine hydrochloride cream on an ear pack, which will be inserted into the ear canal. Packs will be replaced every two days for two weeks. Clinical follow-up will be performed at two weeks, and improvement will be assessed both by symptom relief and microbiological eradication.
The primary outcome is the percentage of patients who improve after terbinafine treatment. Secondary outcomes include symptom reduction and treatment safety. Data will be collected and analyzed using SPSS software. This study is approved by the Ethics Committee of the Faculty of Medicine, Assiut University. All patients will provide written informed consent prior to participation.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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 .
Exclusion Criteria:
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 or allergy to terbinafine or of the study drug.
patients (e.g., /AIDS, chemotherapy, uncontrolled diabetes mellitus).
Pregnant or breastfeeding women.
Patients unable or unwilling to provide or adhere to treatment protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants diagnosed with otomycosis will receive topical terbinafine hydrochloride cream applied on an ear pack. The pack will be inserted into the external auditory canal and changed every 2 days for a total duration of 2 weeks.
Drug: Terbinafine Hydrochloride Cream
Topical antifungal treatment. Terbinafine hydrochloride 1% cream will be applied on an ear pack, inserted into the external auditory canal, and changed every 2 days. Treatment continues for 14 days.
Clinical and mycological cure rate of otomycosis after topical terbinafine
Proportion of participants achieving both: (a) clinical resolution of otomycosis signs and symptoms (itching, otalgia, otorrhea, canal edema/debris) with a normal otoscopic exam, and (b) negative fungal culture from an ear swab. "Cure" is defined as meeting both criteria; otherwise recorded as "no cure."
Time frame: 14 days (±3) from treatment initiation
Clinical and mycological cure rate of otomycosis after topical terbinafine
Proportion of participants achieving both: (a) clinical resolution of otomycosis signs and symptoms (itching, otalgia, otorrhea, canal edema/debris) with a normal otoscopic exam, and (b) negative fungal culture from an ear swab. "Cure" is defined as meeting both criteria; otherwise recorded as "no cure
Time frame: 14 days (±3) from treatment initiation
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terbinafine
Otomycosis