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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
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 :	March 2012
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	April 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Candid

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. adverse effect of treatment [ Time Frame: Five minutes after apply treatment ]
   using questionaire to record adverse effect

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	7 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Thailand
ENT clinic KhonKaen Hospital
KhonKaen, Thailand, 40000

Sponsors and Collaborators

Khon Kaen Hospital

Investigators

Principal Investigator:	Sarisa Romsaithong, M.D.	Unaffiliate

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ms. Sarisa Romsaithong, Medical physician, senior professional level, Khon Kaen Hospital
ClinicalTrials.gov Identifier:	NCT01547221 History of Changes
Other Study ID Numbers:	KKH24-01-2555
First Posted:	March 7, 2012
Last Update Posted:	April 28, 2015
Last Verified:	April 2015

Keywords provided by Ms. Sarisa Romsaithong, Khon Kaen Hospital:

otomycosis; 3% boric acid; 1% clotrimazole ear drop

Additional relevant MeSH terms:

Otomycosis; Mycoses; Ear Diseases; Otorhinolaryngologic Diseases; Tetrahydrozoline; Ophthalmic Solutions; Pharmaceutical Solutions	Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nasal Decongestants; Vasoconstrictor Agents; Respiratory System Agents