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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

Tracking Information
First Submitted Date  ICMJE February 22, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
result as cure rate of otomycosis [ Time Frame: 1 week after treatment ]
otolaryngologist's microscopic finding
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01547221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2012)
adverse effect of treatment [ Time Frame: Five minutes after apply treatment ]
using questionaire to record adverse effect
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
Official Title  ICMJE Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Otomycosis
Intervention  ICMJE
  • Drug: clotrimazole
    single application of 1%clotrimazole ear drop
    Other Name: Candid
  • Drug: 3% Boric acid
    3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital
Study Arms  ICMJE
  • Active Comparator: 3% boric acid
    control
    Intervention: Drug: 3% Boric acid
  • Experimental: 1% clotrimazole ear drop
    3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.
    Intervention: Drug: clotrimazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01547221
Other Study ID Numbers  ICMJE KKH24-01-2555
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ms. Sarisa Romsaithong, Khon Kaen Hospital
Study Sponsor  ICMJE Khon Kaen Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarisa Romsaithong, M.D. Unaffiliate
PRS Account Khon Kaen Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP