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
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