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Clinical Trial Summary

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:

- acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)

- boric acid (3% in isopropyl alcohol)

- gentian violet

- clotrimazole ear drop. But from literature review, there is no comparative study between boric acid and clotrimazole solution before.

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.


Clinical Trial Description

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:

- Symptomatic otomycosis, age more than 7 year.

- Microscopic finding revealed fungus

- KOH smear positive for fungus

Exclusion criteria:

- Pregnancy

- Tympanic membrane perforation and post mastoid surgery

- Co-infection of ear e.g. severe otitis externa,severe myringitis which are needed other medication.

- Previous using topical antibiotic / steroid within 2weeks.

- During usage of systemic antifungal drug

- Allergic to 3% boric acid in 70% alcohol or 1% clotrimazole solution. PICO model: P= otomycosis patient I= 1%clotrimazole ear drop C= 3% boric acid O= result of treatment as cure ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01547221
Study type Interventional
Source Khon Kaen Hospital
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date April 2015

See also
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Recruiting NCT05660382 - Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis Phase 3
Completed NCT03686397 - SVT-15652 Otic Solution for the Treatment of Otomycosis. Phase 3
Not yet recruiting NCT06431542 - Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis Phase 4
Completed NCT06339294 - Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment Phase 1
Not yet recruiting NCT04824261 - Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients. N/A
Completed NCT04432376 - Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis) Phase 2/Phase 3
Completed NCT03686384 - SVT-15652 Otic Solution for the Treatment of Otomycosis Phase 3
Completed NCT04768829 - Antifungal Potential of Moringa Olifera Against Otomycosis Early Phase 1
Completed NCT03130738 - Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis Phase 2