Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.

Study Overview
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Brief Summary
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Otomycosis is a fungal infection that affects one, or occasionally both, of the ears. It mostly affects people who live in warm or tropical areas. It also often affects people who swim frequently, live with diabetes, or have other chronic medical and skin conditions. It is a pathologic entity, with candida and aspergillus the most common fungal species. ]Various predisposing factors include a humid climate, presence of cerumen, instrumentation of the ear, increased use of topical antibiotics / steroid preparations, immune-compromised host, patients who have undergone open cavity mastoidectomy and those who wear hearing aids with occlusive ear mold. The infection is usually unilateral and characterized by inflammatory pruritis, scaling and otalgia.Treatment recommendations have included local debridement, local and systemic antifungal agents and discontinuation of topical antibiotics. Sometimes otomycosis presents as a challenging disease for its long term treatment and follow up, yet its recurrence rate remains high. According to Thai National List of essential medicines for topical antifugal agents are: acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol) boric acid (4% in distilled water) gentian violet clotrimazole ear drop. Some fungal infections such as Aspergillus may be resistant to the usual ear drops. They may require oral medications.

Official Title
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Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.

Conditions
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Otomycosis

Intervention / Treatment
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* Drug: Clotrimazol solution 1%
* Drug: 4%boric acid in distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic otomycosis. Microscopic direct examination and/or culture positive for fungus. Exclusion Criteria: During usage of systemic antifungal drug Allergic to 4% boric acid in distilled water or clotrimazole solution
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>randomized 50 otomycosis patients will receive Clotrimazol solution 1% | Drug: Clotrimazol solution 1%<br>* 50 otomycosis randomized patients will receive Clotrimazol solution 1% The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.<br>|
| Active Comparator: group 2<br>randomized 50 otomycosis patients will receive 4%boric acid in distilled water | Drug: 4%boric acid in distilled water<br>* 50 otomycosis randomized patients will receive 4%boric acid in distilled water The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curative rate of otomycosis |  | 1 month |