Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients

Not Applicable

Completed

• Conditions: Otomycosis
• Interventions: Drug: 3% Boric acid; Drug: clotrimazole

• Registration Number: NCT01547221
• Lead Sponsor: Khon Kaen Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2012-02-22
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-03
• Study First Posted: 2012-03-07
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 medications
• Previous using topical antibiotic / steroid within 2weeks.
• During usage of systemic antifungal drug
• Allergic to 3% boric acid in70% alcohol or 1% clotrimazole solution.
• Those who can not come to follow up after one week of the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% boric acid	3% Boric acid	control
1% clotrimazole ear drop	clotrimazole	3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.

Primary Outcome Measures

Name	Time	Method
result as cure rate of otomycosis	1 week after treatment	otolaryngologist's microscopic finding

Secondary Outcome Measures

Name	Time	Method
adverse effect of treatment	Five minutes after apply treatment	using questionaire to record adverse effect

Trial Locations

Locations (1)

ENT clinic KhonKaen Hospital; 🇹🇭 KhonKaen, Thailand