Skip to main content
OpenTrials
Completed

NCT Number: NCT01547221

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otomycosis Bacterial Infections and Mycoses Ear Diseases Infections Mycoses Otorhinolaryngologic Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT clinic KhonKaen Hospital

KhonKaen, 40000, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clotrimazole

Drug

single application of 1%clotrimazole ear drop

Other names: Candid

3% Boric acid

Drug

3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital

Primary outcomes

  1. result as cure rate of otomycosis

    Time frame: 1 week after treatment

    otolaryngologist's microscopic finding

Secondary outcomes

  1. adverse effect of treatment

    Time frame: Five minutes after apply treatment

    using questionaire to record adverse effect

Sponsors and collaborators

Lead sponsor

Khon Kaen Hospital

Other Gov

Registry information

Official study title

Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 7, 2012
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.