Treatment of fungal infection in the ear, a comparison of topical treatments (clotrimazole vs terbinafine)
| ISRCTN | ISRCTN17978168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17978168 |
| Sponsor | Universidad Autónoma de Sinaloa |
| Funder | Universidad Autónoma de Sinaloa |
- Submission date
- 02/09/2026
- Registration date
- 26/09/2026
- Last edited
- 17/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Erika Celis-Aguilar
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
Centro de Investigación y Docencia en Ciencias de la Salud, Universidad Autónoma de Sinaloa
Eustaquio Buelna 91 Col Burocrata Culiacan Sin
Culiacán
80107
Mexico
| Phone | +52 (0)6677587933 |
|---|---|
| erika.celis@uas.edu.mx |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Sequential |
| Purpose | Treatment |
| Scientific title | Efficacy of topical terbinafine versus clotrimazole for the treatment of otomycosis: a randomized controlled trial |
| Study objectives | The aim of this study was to compare the clinical efficacy and safety of topical terbinafine versus topical clotrimazole 1% in patients with otomycosis. |
| Ethics approval(s) |
Approved 23/03/2022, Institutional Research Ethics Committee (CONBIOÉTICA-25-CEI-001-20180523) (Centro de Investigación y Docencia en Ciencias de la Salud, Universidad Autónoma de Sinaloa, Eustaquio Buelna 91, Col Burocrata Culiacan Sin, Culiacan, 80060, Mexico; +52 (0)6671023474; cei.cidocs.hc@uas.edu.mx), ref: 086 |
| Health condition(s) or problem(s) studied | Otomycosis |
| Intervention | Participants were allocated using computer-generated unrestricted simple randomization. Before treatment initiation, all patients underwent meticulous microscopic debridement of the external auditory canal. Participants assigned to the control group received topical 1% clotrimazole cream, whereas participants assigned to the intervention group received topical 1% terbinafine cream. In both groups, the medication was applied weekly until complete occlusion of the external auditory canal. At the first follow-up visit, residual medication was removed, microscopic cleaning was repeated, and the same treatment was reapplied. Patients were followed weekly, the end of period follow up was 3 weeks. Patients with persistent clinical evidence of otomycosis after completion of the assigned treatment follow up received rescue therapy with the alternative antifungal therapy, for example, patients in the clotrimazole arm received terbinafine and vice versa. All participants received standardized instructions to keep the affected ear dry and avoid recognized predisposing factors throughout the study period. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Terbinafine, clotrimazole |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/07/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 87 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Adults aged 18 years or older of either sex 2. Clinical diagnosis of otomycosis established by medical history, otomicroscopic examination, and mycological evaluation |
| Key exclusion criteria | 1. Patients with concomitant otologic diseases other than otomycosis 2. Allergy to study medications 3. Pregnancy 4. Inability to complete follow-up |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
17/09/2026: Study's existence confirmed by the Institutional Research Ethics Committee.
