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Otomycosis is a fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. A total of 60 patients diagnosed with otomycosis were enrolled and were randomly assigned in equal numbers to one of the two treatment groups. One group received clotrimazole drops three times daily for two weeks, while the other group received 2% salicylic acid drops at the same frequency and for the same duration. Patients were assessed at the start of treatment and again after two weeks. The main outcome measure was relief of ear blockage, which reflected improvement in canal patency after treatment. It was hypothesized that topical clotrimazole would be more effective than 2% salicylic acid in clearing ear blockage and improving short-term clinical recovery in patients with otomycosis. This study was conducted to provide evidence for selecting an effective, practical, and affordable topical treatment for routine clinical use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Clotrimazole | Experimental | Received three drops of clotrimazole in the affected ear three times daily for two weeks. |
|
| Group B 2% Salicylic Acid | Active Comparator | Received three drops of 2% salicylic acid in the affected ear three times daily for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clotrimazole | Drug | Three drops of clotrimazole were administered in the affected ear three times daily for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of ear blockage | Ear blockage was assessed clinically as present or absent in the affected ear. The primary outcome measure was the proportion of patients who achieved absence of ear blockage after treatment, reflecting restoration of external auditory canal patency. The assessment was performed by the same ENT consultant in both treatment groups. | 2 weeks after initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of fungal debris | Fungal debris in the external auditory canal was assessed clinically as present or absent. The secondary outcome measure was the proportion of patients who showed clearance of fungal debris after treatment, as evaluated by the same ENT consultant . | 2 weeks after initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Hasnain | Mayo Hospital Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Hospital, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
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| ID | Term |
|---|---|
| D059249 | Otomycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004427 | Ear Diseases |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| D020156 | Salicylic Acid |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 2% Salicylic Acid | Drug | Three drops of 2% salicylic acid were administered in the affected ear three times daily for two weeks. |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D012459 |
| Salicylates |
| D062385 | Hydroxybenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |