Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
|ClinicalTrials.gov Identifier: NCT01547221|
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Otomycosis||Drug: clotrimazole Drug: 3% Boric acid||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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
- result as cure rate of otomycosis [ Time Frame: 1 week after treatment ]otolaryngologist's microscopic finding
- adverse effect of treatment [ Time Frame: Five minutes after apply treatment ]using questionaire to record adverse effect
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547221
|ENT clinic KhonKaen Hospital|
|KhonKaen, Thailand, 40000|
|Principal Investigator:||Sarisa Romsaithong, M.D.||Unaffiliate|