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

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

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.

Study Overview

• Status: Completed
• Conditions: Otomycosis
• Intervention / Treatment: Drug: 3% Boric acid; Drug: clotrimazole

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • KhonKaen, Thailand, 40000
    • ENT clinic KhonKaen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
result as cure rate of otomycosis	otolaryngologist's microscopic finding	1 week after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effect of treatment	using questionaire to record adverse effect	Five minutes after apply treatment

Collaborators and Investigators

• Sponsor: Khon Kaen Hospital
• Investigators: Principal Investigator: Sarisa Romsaithong, M.D., Unaffiliate

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 3, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: otomycosis; 3% boric acid; 1% clotrimazole ear drop
• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otomycosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: KKH24-01-2555