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

Information source: Khon Kaen Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Otomycosis

Intervention: clotrimazole (Drug); 3% Boric acid (Drug)

Phase: N/A

Status: Completed

Sponsored by: Khon Kaen Hospital

Official(s) and/or principal investigator(s):
Sarisa Romsaithong, M.D., Principal Investigator, Affiliation: Unaffiliate

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.

Clinical Details

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

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

Primary outcome: result as cure rate of otomycosis

Secondary outcome: adverse effect of treatment

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

Eligibility

Minimum age: 7 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

ENT clinic KhonKaen Hospital, KhonKaen 40000, Thailand
Additional Information

Starting date: March 2012
Last updated: April 27, 2015

Page last updated: August 23, 2015

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