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

Otomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547221
• Other study ID #: KKH24-01-2555
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: April 27, 2015
• Start date: March 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Khon Kaen Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Otomycosis

Intervention

Drug:
• clotrimazole
single application of 1%clotrimazole ear drop
• 3% Boric acid
3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital

Locations

Country	Name	City	State
Thailand	ENT clinic KhonKaen Hospital	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	result as cure rate of otomycosis	otolaryngologist's microscopic finding	1 week after treatment	No
Secondary	adverse effect of treatment	using questionaire to record adverse effect	Five minutes after apply treatment	Yes