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

Assiut University

Status: Unknown

Conditions: Otomycosis

Treatments: Drug: Clotrimazol solution 1%; Drug: 4%boric acid in distilled water

Study type: Interventional

Funder types: Other

Identifiers

NCT04824261

otomycosis

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

group 1

Active Comparator group

Description:

randomized 50 otomycosis patients will receive Clotrimazol solution 1%

Treatment:

Drug: Clotrimazol solution 1%

group 2

Active Comparator group

Description:

randomized 50 otomycosis patients will receive 4%boric acid in distilled water

Treatment:

Drug: 4%boric acid in distilled water