OtomycosisPhase 2/3NCT04432376

Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)

A Phase 2/3 study testing miconazole 2% oil in people with Otomycosis, run by Hill Dermaceuticals, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 7 years and olderHealthy volunteers can take part
Conditions the study is for: Otomycosis
What is being tested?: miconazole 2% oil
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 382 participants
Where: 12 sitesUnited States
Study dates: 8 Jul 2020to 1 Nov 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Randomized blinded initial phase of study:
Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only,
Intact tympanic membrane in the ear(s) to be treated with study drug,
In general good health as determined by medical examination and medical history,
Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.
Open-label second phase of study:

Show all 9Show fewer

Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug,
In general good health as determined by medical examination and medical history,
Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.

Who cannot join

Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections that require antimicrobial treatment,
Disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s);
Tympanostomy tube or perforated tympanic membrane;
History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, except for prior tympanostomy tube(s) that have already been removed and completely healed;
Use of any topical medicated treatments for otomycosis within 14 days of study entry;
Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry;

Show all 10Show fewer

Fever of ≥100°F at study entry;
Otomycosis that has been unresponsive to previous antifungal treatment;
Known hypersensitivity to any of the components in the test formulation;
Participation in another investigative trial within 28 days of study entry

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Head and Neck Surgery Specialists
Chula Vista, California, 91910
University of Missouri
Columbia, Missouri, 65212
OnSite Clinical Solutions
Dillon, South Carolina, 29536
West Houston Clinical Research Services
Houston, Texas, 77055
UCSD
La Jolla, California, 92037
Lake ENT & FPS
Leesburg, Florida, 34748
Advanced ENT & Allergy
Louisville, Kentucky, 40220
DelRicht Research
New Orleans, Louisiana, 70124
Carolina ENT
Orangeburg, South Carolina, 29118
Research Your Health
Plano, Texas, 75093
DaVinci Research, LLC
Roseville, California, 95661
Sacramento ENT / DaVinci Research
Sacramento, California, 95815

Other trials in United States

About this study

Official title: Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation

This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in the first portion of the study will have active fungal infection of the ear(s) and will be treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the affected ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug following the same application of 5 drops into the ear(s) twice daily for 14 days.

The intention of the study is to evaluate the efficacy of Miconazole Oil on fungal infection of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously. This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day for 14 consecutive days.

Read the detailed description

This study will be conducted in 2 portions:

Enrollment A, which will consist of 2 treatment periods as follows and will be conducted in subjects with otomycosis:
A randomized, double-blind, parallel-group treatment period. This treatment period will be referred to as the "Randomization Period" and will be followed by:
An optional, open-label treatment period with miconazole oil. This treatment period will be referred to as the "Optional Open-label Extension."
Enrollment B will consist of open-label treatment with miconazole oil in subjects who will not be required to have signs and symptoms of otomycosis.

The study will start with Enrollment A, with an estimated 220 male or female subjects with otomycosis. Subjects will be randomly assigned in a 1:1 ratio to receive miconazole oil or vehicle (placebo), for 14 days. The study drug will be administered as 5 drops per ear at ~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis.

In the Randomization Period, both the subject and the investigator and study staff are blinded to the contents of the study drug.

At Screening/Baseline (Day 1), assessment of the signs and symptoms of otomycosis (pruritus, debris, visual examination for presence of fungal elements, and aural fullness), evaluation of medical history, pregnancy screening in female of childbearing potential, and, prior and concomitant medications, will be collected. Subjects with positive signs and symptoms of otomycosis and who meet all eligibility criteria will enter the study. Fungal culture of affected ear(s) will be taken, debris will be cleaned from the affected ear(s), and subject will be randomized and study drug dispensed. Treatment will be for 14 days. Day 8 On Treatment Visit will include clinical evaluation of otomycosis, cleaning of ear(s), and assessment of Adverse Events (AEs) and concomitant medications, and continue treatment up to Day 14. Day 15 End of Treatment Visit will include clinical evaluation of otomycosis and fungal culture, adverse events including Treatment emergent adverse events (TEAEs) and concomitant medications assessed. Day 22 Test of Cure Visit is an assessment of clinical signs and symptoms of otomycosis and fungal culture, AEs and concomitant medications assessed, and urine pregnancy test performed in women of childbearing potential.

Only the subjects that had positive fungal (mycological) culture at Baseline will be evaluated for efficacy. This is the Modified intent-to-treat (MITT) population.

The Optional Open-label Extension period will allow subjects to get miconazole oil for 14 days. No unblinding of the subject's treatment in the Randomization Period will occur at this time.

For Enrollment B, male or female subjects will be enrolled to receive miconazole oil to use for 14 days and will be evaluated for safety.

Intent-to-Treat (ITT) population are all subjects enrolled and randomized to treatment. Modified Intent-to-Treat (MITT) population are subjects in the ITT population with a clinical diagnosis of otomycosis confirmed by positive fungal culture at Baseline.

Conditions: Otomycosis
Being tested: miconazole 2% oil, vehicle oil
Medical subject headings: Otomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

miconazole 2% oilDrug
Also called active treatment
Drug treatment of otomycosis for 14 days
vehicle oilDrug
Also called placebo treatment
Placebo treatment of otomycosis for 14 days

Study groups in NCT04432376
Study group	Role	What they receive
Active treatment arm	Active comparator	Treatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days Receives: Drug: miconazole 2% oil
Placebo treatment arm	Placebo comparator	Treatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days Receives: Drug: vehicle oil
Open-label treatment arm	Other	Application of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days Receives: Drug: miconazole 2% oil

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Therapeutic Cure
"therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment.
Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).
Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best.
Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best.
Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.
Measured: 21 days from first day of drug application

Secondary outcomes (2)

Percentage of Subjects With Mycological Cure
Mycological cure is a negative mycological culture for the study ear at test of cure visit, in Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment.
Grading is based on positive or negative mycological (fungal) culture. Negative culture is required.
Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.
Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).
Measured: 21 days from first day of drug application
Percentage of Subjects With Clinical Cure
Absence of all otomycosis signs and symptoms according to the scales for each individual sign/symptom. Score=0 is best.
Clinical cure is absence of all otomycosis signs and symptoms of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best.
Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment.
ITT (intent to treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).
Measured: 21 days from first day of drug application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 20201 Nov 2021

First posted16 Jun 2020
Study start8 Jul 2020
Primary completion1 Nov 2021
Study completion1 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Two phases; initial is randomized double-blind active vs placebo on a pre-determined number of subjects with otomycosis, to finish before starting second phase. Second phase is open-label use on diseased or healthy subjects to evaluate safety. Subjects from initial phase may crossover to second phase open-label if they meet the requirements, and new diseased or healthy subjects meeting requirements may enroll in this open-label phase.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04432376
Sponsor's protocol ID: MZ-0120-ESP3-052
Status last verified: Jan 2024
First submitted: 11 Jun 2020
Last updated: 19 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Otomycosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Phase III Study of the Efficacy and Safety of Miconazole Oil Versus Vehicle Oil in the Treatment of Otomycosis, Followed by an Open-label Safety Evaluation
ClinicalTrials.gov ID: NCT04432376
Acronym / sponsor ID: MZ-0120-ESP3-052
Conditions: Otomycosis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 382 participants (actual)
Lead sponsor: Hill Dermaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Abond CRO Inc.
Study start: 8 Jul 2020 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 16 Jun 2020 (actual)
Results: Posted 4 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will be conducted in 2 portions:

Enrollment A, which will consist of 2 treatment periods as follows and will be conducted in subjects with otomycosis:
A randomized, double-blind, parallel-group treatment period. This treatment period will be referred to as the "Randomization Period" and will be followed by:
An optional, open-label treatment period with miconazole oil. This treatment period will be referred to as the "Optional Open-label Extension."
Enrollment B will consist of open-label treatment with miconazole oil in subjects who will not be required to have signs and symptoms of otomycosis.

In the Randomization Period, both the subject and the investigator and study staff are blinded to the contents of the study drug.

Only the subjects that had positive fungal (mycological) culture at Baseline will be evaluated for efficacy. This is the Modified intent-to-treat (MITT) population.

The Optional Open-label Extension period will allow subjects to get miconazole oil for 14 days. No unblinding of the subject's treatment in the Randomization Period will occur at this time.

For Enrollment B, male or female subjects will be enrolled to receive miconazole oil to use for 14 days and will be evaluated for safety.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: Two phases; initial is randomized double-blind active vs placebo on a pre-determined number of subjects with otomycosis, to finish before starting second phase. Second phase is open-label use on diseased or healthy subjects to evaluate safety. Subjects from initial phase may crossover to second phase open-label if they meet the requirements, and new diseased or healthy subjects meeting requirements may enroll in this open-label phase.

Arm	Type	Receives
Active treatment arm	Active comparator	Drug: miconazole 2% oilTreatment with miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days
Placebo treatment arm	Placebo comparator	Drug: vehicle oilTreatment with the vehicle oil, placebo, 5 drops into each ear twice daily for 14 consecutive days
Open-label treatment arm	Other	Drug: miconazole 2% oilApplication of miconazole 2% oil, 5 drops into each ear twice daily for 14 consecutive days

Who may qualify

Ages: 7 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only,
Intact tympanic membrane in the ear(s) to be treated with study drug,
In general good health as determined by medical examination and medical history,
Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study.
Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug,

Key exclusion criteria (10 listed)

Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections that require antimicrobial treatment,
Disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s);
Tympanostomy tube or perforated tympanic membrane;
History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, except for prior tympanostomy tube(s) that have already been removed and completely healed;
Use of any topical medicated treatments for otomycosis within 14 days of study entry;

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
miconazole 2% oilAlso: active treatmentDrug treatment of otomycosis for 14 days	Drug	Active treatment arm, Open-label treatment arm
vehicle oilAlso: placebo treatmentPlacebo treatment of otomycosis for 14 days	Drug	Placebo treatment arm

Primary outcome

Percentage of Subjects With Therapeutic Cure
Time frame: 21 days from first day of drug application
"therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best. Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline.

2 secondary outcomes

Percentage of Subjects With Mycological Cure
Time frame: 21 days from first day of drug application
Percentage of Subjects With Clinical Cure
Time frame: 21 days from first day of drug application

Results and safety

Results posted to the registry on 4 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment Arm	89	84
Placebo Treatment Arm	90	79
Open-label Application Group	0	0

Primary outcome: Percentage of Subjects With Therapeutic Cure

Time frame: 21 days from first day of drug application. Count of participants. Unit: Participants

Measure	Active Treatment Arm n = 67	Placebo Treatment Arm n = 64
Achieved Therapeutic cure (Score=0 fungal culture and clinical signs,symptoms)	14	11
Not Achieve Therapeutic cure (Positive fungal culture AND/OR clinical score 1 or greater each s/s	53	53

Population analysed: MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT (intent-to-treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) are collected at the start and during use of study drug, Day 1 to Day 14 of study drug application. Collection of adverse events start the day the patient first applied the study drug and end the day of the patient's last study visit, Day 21. Adverse events were monitored through study completion.. Other adverse events reported at 1.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment Arm	1 of 89 (1.1%)	41 of 89 (46.1%)	0 of 89
Placebo Treatment Arm	0 of 90 (0%)	51 of 90 (56.7%)	0 of 90
Open-label Treatment Arm	0 of 203 (0%)	9 of 203 (4.4%)	0 of 203

Limitations and caveats (from the sponsor): The limited number of patients with otomycosis at any one time, and the lack of standardized FDA-approved clinical studies on otomycosis have proven to be challenging and difficult to assign predetermined analysis endpoints. This is in line with the challenges described in the FDA Accelerating Rare disease Cures Program, such as challenges faced when using well-established trial designs, and complexities in endpoint selection when there is limited information or understanding of the disease.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Arnaldo Rivera, MD principal investigator

University of Missouri-Columbia

Quyen T Nguyen, MD principal investigator

UCSD

Kenneth Hodge, MD principal investigator

Advanced ENT and Allergy

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing miconazole 2% oil in people with Otomycosis, run by Hill Dermaceuticals, Inc. at 12 sites in United States.

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 9 inclusion and 10 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects With Therapeutic Cure (time frame: 21 days from first day of drug application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432376.

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 19 Jan 2024.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (9 listed)

Key exclusion criteria (10 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Percentage of Subjects With Therapeutic Cure

Adverse events

Research links

Related trials for Otomycosis

Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis

Terbinafine Hydrochloride for the Treatment of Otomycosis

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Percentage of Subjects With Therapeutic Cure

Adverse events