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

Sponsor

Khon Kaen Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01547221

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Otomycosis	Drug: clotrimazole Drug: 3% Boric acid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3% boric acid control	Drug: 3% Boric acid 3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital
Experimental: 1% clotrimazole ear drop 3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.	Drug: clotrimazole single application of 1%clotrimazole ear drop Other Names: Candid

Arm

Intervention/Treatment

Active Comparator: 3% boric acid

control

Drug: 3% Boric acid

3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital

Experimental: 1% clotrimazole ear drop

3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.

Drug: clotrimazole

single application of 1%clotrimazole ear drop

Other Names:

Candid

Outcome Measures

Primary Outcome Measures

result as cure rate of otomycosis [1 week after treatment]
otolaryngologist's microscopic finding

Secondary Outcome Measures

adverse effect of treatment [Five minutes after apply treatment]
using questionaire to record adverse effect

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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