OtomycosisNCT01547221
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients
A study testing clotrimazole and 3% Boric acid in people with Otomycosis, run by Khon Kaen Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Otomycosis
- What is being tested?
- clotrimazole and 3% Boric acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic otomycosis, age more than 7 year.
- Microscopic finding revealed fungus
- KOH smear positive for fungus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial
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:
Read more
- 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.
Read the 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
- Conditions
- Otomycosis
- Being tested
- clotrimazole, 3% Boric acid
- Keywords
- otomycosis, 3% boric acid, 1% clotrimazole ear drop
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clotrimazoleDrug
Also called Candid
single application of 1%clotrimazole ear drop
3% Boric acidDrug
3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital
| Study group | Role | What they receive |
|---|---|---|
| 3% boric acid | Active comparator | control Receives: Drug: 3% Boric acid |
| 1% clotrimazole ear drop | Experimental | 3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention. Receives: Drug: clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
result as cure rate of otomycosis
otolaryngologist's microscopic finding
Measured: 1 week after treatment
Secondary outcomes (1)
adverse effect of treatment
using questionaire to record adverse effect
Measured: Five minutes after apply treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ms. Sarisa Romsaithong, Khon Kaen Hospital
- Investigators
- Sarisa Romsaithong, M.D., Principal investigator, Unaffiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547221
- Sponsor's protocol ID
- KKH24-01-2555
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2012
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01547221
- Acronym / sponsor ID
- KKH24-01-2555
- Conditions
- Otomycosis
- Keywords
- otomycosis, 3% boric acid, 1% clotrimazole ear drop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Khon Kaen HospitalOther government
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% boric acid | Active comparator | Drug: 3% Boric acidcontrol |
| 1% clotrimazole ear drop | Experimental | Drug: clotrimazole3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic otomycosis, age more than 7 year.
- Microscopic finding revealed fungus
- KOH smear positive for fungus
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clotrimazoleAlso: Candidsingle application of 1%clotrimazole ear drop | Drug | 1% clotrimazole ear drop |
| 3% Boric acid3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital | Drug | 3% boric acid |
Primary outcome
result as cure rate of otomycosis
Time frame: 1 week after treatment
otolaryngologist's microscopic finding
1 secondary outcome
adverse effect of treatment
Time frame: Five minutes after apply treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
Not yet recruiting
Terbinafine Hydrochloride for the Treatment of Otomycosis
Otomycosis, Fungal Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarisa Romsaithong, M.D. principal investigator
Unaffiliate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clotrimazole and 3% Boric acid in people with Otomycosis, run by Khon Kaen Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
result as cure rate of otomycosis (time frame: 1 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.