Clinical trial NCT01547221: Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
Official title: Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otomycosis
Keywords: otomycosis
3% boric acid
1% clotrimazole ear drop
Lead sponsor: Khon Kaen Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: result as cure rate of otomycosis
timeFrame: 1 week after treatment
Secondary outcomes:
measure: adverse effect of treatment
timeFrame: Five minutes after apply treatment
Other outcomes:
Locations:
city: KhonKaen
country: Thailand
facility: ENT clinic KhonKaen Hospital
Study officials:
affiliation: Unaffiliate
name: Sarisa Romsaithong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: