Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- result as cure rate of otomycosis [ Time Frame: 1 week after treatment ] [ Designated as safety issue: No ]otolaryngologist's microscopic finding
- adverse effect of treatment [ Time Frame: Five minutes after apply treatment ] [ Designated as safety issue: Yes ]using questionaire to record adverse effect
|Study Start Date:||March 2012|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: 3% boric acid
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.
single application of 1%clotrimazole ear drop
Other Name: Candid
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.
- Symptomatic otomycosis, age more than 7 year.
- Microscopic finding revealed fungus
- KOH smear positive for fungus
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547221
|ENT clinic KhonKaen Hospital|
|KhonKaen, Thailand, 40000|
|Principal Investigator:||Sarisa Romsaithong, M.D.||Unaffiliate|