Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
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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 (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 |
- result as cure rate of otomycosis [ Time Frame: 1 week after treatment ]otolaryngologist's microscopic finding
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Thailand | |
| ENT clinic KhonKaen Hospital | |
| KhonKaen, Thailand, 40000 | |
| 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 |
| First Submitted: | February 22, 2012 |
| First Posted: | March 7, 2012 |
| 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 |