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Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients

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ClinicalTrials.gov Identifier: NCT01547221
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Ms. Sarisa Romsaithong, Khon Kaen Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Otomycosis Drug: clotrimazole Drug: 3% Boric acid Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. adverse effect of treatment [ Time Frame: Five minutes after apply treatment ]
    using questionaire to record adverse effect


Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 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