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

This study is currently recruiting participants.
Verified April 2013 by Khon Kaen Hospital
Sponsor:
Information provided by (Responsible Party):
Ms. Sarisa Romsaithong, Khon Kaen Hospital
ClinicalTrials.gov Identifier:
NCT01547221
First received: February 22, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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: Boric acid

Study Type: Interventional
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 Isopropyl Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Khon Kaen Hospital:

Primary Outcome Measures:
  • result as cure rate of otomycosis [ Time Frame: 1 week after treatment ] [ Designated as safety issue: No ]
    otolaryngologist's microscopic finding


Secondary Outcome Measures:
  • adverse effect of treatment [ Time Frame: Five minutes after apply treatment ] [ Designated as safety issue: Yes ]
    using questionaire to record adverse effect


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3% boric acid
control
 Drug: Boric acid
3% boric acid
Active Comparator: 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547221

Contacts
Contact: Sarisa Romsaithong, M.D. 66-089-7112070 itzmeboom@yahoo.com

Locations
Thailand
ENT clinic KhonKaen Hospital Recruiting
KhonKaen, Thailand, 40000
Contact: Sarisa Romsaithong, M.D.            
Sub-Investigator: Sanguansak Thanaviratananich, M.D.            
Sponsors and Collaborators
Khon Kaen Hospital
Investigators
Principal Investigator: Sarisa Romsaithong, M.D. Unaffiliate
  More Information

No publications provided

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 15, 2013
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen Hospital:
otomycosis
3% boric acid
1% clotrimazole ear drop
effectiveness of antifungal agent

Additional relevant MeSH terms:
Tetrahydrozoline
Clotrimazole
Miconazole
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on May 16, 2013