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

Not Applicable

• Conditions: Otomycosis
• Interventions: Drug: 4%boric acid in distilled water; Drug: Clotrimazol solution 1%

• Registration Number: NCT04824261
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-27
• Study First Submitted QC: 2021-03-27
• Last Update Submitted: 2021-03-27
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Study Start: 2021-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	4%boric acid in distilled water	randomized 50 otomycosis patients will receive 4%boric acid in distilled water
group 1	Clotrimazol solution 1%	randomized 50 otomycosis patients will receive Clotrimazol solution 1%

Primary Outcome Measures

Name	Time	Method
Curative rate of otomycosis	1 month