OtomycosisNCT07152327
Terbinafine Hydrochloride for the Treatment of Otomycosis
A study testing Terbinafine Hydrochloride Cream in people with Otomycosis and Fungal Ear Infection, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Otomycosis, Fungal Ear Infection
- What is being tested?
- Terbinafine Hydrochloride Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Terbinafine Hydrochloride in the Treatment of Otomycosis: Basic and Clinical Evaluation
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.
Read the detailed description
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.
- Conditions
- Otomycosis, Fungal Ear Infection
- Being tested
- Terbinafine Hydrochloride Cream
- Keywords
- Otomycosis, Aspergillus, Candida
- Medical subject headings
- Otomycosis, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine Hydrochloride CreamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine Hydrochloride Cream | Experimental | 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. Receives: Drug: Terbinafine Hydrochloride Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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
Measured: 14 days (±3) from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive terbinafine hydrochloride cream applied on an ear pack. There is no comparator arm in this study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohamed Samy Mohamed Abd Ellatief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152327
- Sponsor's protocol ID
- OTO-Terbinafine-2025
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.
PubMed 29786478Hentzer E. Histologic studies of the normal mucosa in the middle ear, mastoid cavities and Eustachian tube. Ann Otol Rhinol Laryngol. 1970 Aug;79(4):825-33. doi: 10.1177/000348947007900414. No abstract available.
PubMed 5526992
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Terbinafine Hydrochloride in the Treatment of Otomycosis: Basic and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07152327
- Acronym / sponsor ID
- OTO-Terbinafine-2025
- Conditions
- Otomycosis, Fungal Ear Infection
- Keywords
- Otomycosis, Aspergillus, Candida
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive terbinafine hydrochloride cream applied on an ear pack. There is no comparator arm in this study.
| Arm | Type | Receives |
|---|---|---|
| Terbinafine Hydrochloride Cream | Experimental | Drug: Terbinafine Hydrochloride CreamParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terbinafine Hydrochloride CreamTopical 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. | Drug | Terbinafine Hydrochloride Cream |
Primary outcome
Clinical and mycological cure rate of otomycosis after topical terbinafine
Time frame: 14 days (±3) from treatment initiation
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."
Clinical and mycological cure rate of otomycosis after topical terbinafine
Time frame: 14 days (±3) from treatment initiation
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Results publication: PubMed 29786478From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.
- Results publication: PubMed 5526992Hentzer E. Histologic studies of the normal mucosa in the middle ear, mastoid cavities and Eustachian tube. Ann Otol Rhinol Laryngol. 1970 Aug;79(4):825-33. doi: 10.1177/000348947007900414. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Terbinafine Hydrochloride Cream in people with Otomycosis and Fungal Ear Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa samy abdellatif, MBBCh (01099427096, nemo.memo19.nm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and mycological cure rate of otomycosis after topical terbinafine (time frame: 14 days (±3) from treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.