Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients - Full Text View

Purpose

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	Intervention
Otomycosis	Drug: clotrimazole Drug: 3% Boric acid


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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

Resource links provided by NLM:

Drug Information available for: Tetrahydrozoline hydrochloride Boric acid Clotrimazole

U.S. FDA Resources

Further study details as provided by Ms. Sarisa Romsaithong, Khon Kaen Hospital:

Primary Outcome Measures:

result as cure rate of otomycosis [ Time Frame: 1 week after treatment ]
otolaryngologist's microscopic finding

Secondary Outcome Measures:

adverse effect of treatment [ Time Frame: Five minutes after apply treatment ]
using questionaire to record adverse effect


Enrollment:	120
Study Start Date:	March 2012
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 3% boric acid control	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.	Drug: clotrimazole single application of 1%clotrimazole ear drop Other Name: Candid

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


Ages Eligible for Study:	7 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547221

Locations


Thailand
ENT clinic KhonKaen Hospital
KhonKaen, Thailand, 40000

Sponsors and Collaborators

Khon Kaen Hospital

Investigators


Principal Investigator:	Sarisa Romsaithong, M.D.	Unaffiliate

More Information


Responsible Party:	Ms. Sarisa Romsaithong, Medical physician, senior professional level, Khon Kaen Hospital
ClinicalTrials.gov Identifier:	NCT01547221 History of Changes
Other Study ID Numbers:	KKH24-01-2555
Study First Received:	February 22, 2012
Last Updated:	April 27, 2015

Keywords provided by Ms. Sarisa Romsaithong, Khon Kaen Hospital:


otomycosis 3% boric acid 1% clotrimazole ear drop

Additional relevant MeSH terms:


Otomycosis Mycoses Ear Diseases Otorhinolaryngologic Diseases Tetrahydrozoline Ophthalmic Solutions Pharmaceutical Solutions	Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents

ClinicalTrials.gov processed this record on June 23, 2017