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Otomycosis is a superficial fungal infection of the external ear canal. Patients should be treated with cleaning fungal debris combined with topical antifungal agent. There is wide range of topical antifungal agents. However, there is still no consensus of the most effective topical antifungal agents in treatment otomycosis is still lacking.
According to Thai National List of essential medicines for topical antifugal agents are:
Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.
The hypothesis has been formulated by H0 and Ha. H0 = 1% clotrimazole solution has clinical effectiveness not different from 3% boric acid in 70% alcohol for the treatment of otomycosis.
Ha = 1% clotrimazole solution has more clinical effectiveness than 3% boric acid in 70% alcohol for the treatment of otomycosis.
Inclusion criteria:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3% boric acid | Active Comparator | control |
|
| 1% clotrimazole ear drop | Experimental | 3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clotrimazole | Drug | single application of 1%clotrimazole ear drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| result as cure rate of otomycosis | otolaryngologist's microscopic finding | 1 week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effect of treatment | using questionaire to record adverse effect | Five minutes after apply treatment |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarisa Romsaithong, M.D. | Unaffiliate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT clinic KhonKaen Hospital | KhonKaen | KhonKaen | 40000 | Thailand |
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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 |
| C032688 | boric acid |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 3% Boric acid | Drug | 3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital |
|
| D010038 |
| Otorhinolaryngologic Diseases |