OtomycosisNCT07535424
Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis
A study testing clotrimazole and 2% Salicylic Acid in people with Otomycosis, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
Otomycosis is a fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Otomycosis
- What is being tested?
- clotrimazole and 2% Salicylic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2024to 20 Oct 2025
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both genders
- Age 5 to 60 years
- Patients having confirmed diagnosis of otomycosis
Who cannot join
- Chronic suppurative otitis media
- Other ear pathologies
- Immunodeficiency
- Diabetes mellitus
- Receiving steroids
- Receiving chemotherapy
- Receiving radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Otomycosis is a fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. A total of 60 patients diagnosed with otomycosis were enrolled and were randomly assigned in equal numbers to one of the two treatment groups. One group received clotrimazole drops three times daily for two weeks, while the other group received 2% salicylic acid drops at the same frequency and for the same duration. Patients were assessed at the start of treatment and again after two weeks. The main outcome measure was relief of ear blockage, which reflected improvement in canal patency after treatment. It was hypothesized that topical clotrimazole would be more effective than 2% salicylic acid in clearing ear blockage and improving short-term clinical recovery in patients with otomycosis. This study was conducted to provide evidence for selecting an effective, practical, and affordable topical treatment for routine clinical use.
- Conditions
- Otomycosis
- Being tested
- clotrimazole, 2% Salicylic Acid
- Keywords
- fungal otitis externa, external auditory canal fungal infection, clotrimazole, salicylic acid, topical treatment, ear blockage
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clotrimazoleDrug
Three drops of clotrimazole were administered in the affected ear three times daily for two weeks.
2% Salicylic AcidDrug
Three drops of 2% salicylic acid were administered in the affected ear three times daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A Clotrimazole | Experimental | Received three drops of clotrimazole in the affected ear three times daily for two weeks. Receives: Drug: clotrimazole |
| Group B 2% Salicylic Acid | Active comparator | Received three drops of 2% salicylic acid in the affected ear three times daily for two weeks. Receives: Drug: 2% Salicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of ear blockage
Ear blockage was assessed clinically as present or absent in the affected ear. The primary outcome measure was the proportion of patients who achieved absence of ear blockage after treatment, reflecting restoration of external auditory canal patency. The assessment was performed by the same ENT consultant in both treatment groups.
Measured: 2 weeks after initiation of treatment.
Secondary outcomes (1)
Clearance of fungal debris
Fungal debris in the external auditory canal was assessed clinically as present or absent. The secondary outcome measure was the proportion of patients who showed clearance of fungal debris after treatment, as evaluated by the same ENT consultant .
Measured: 2 weeks after initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Nov 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Muhammad Hasnain, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535424
- Sponsor's protocol ID
- Mayo4
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis
- ClinicalTrials.gov ID
- NCT07535424
- Acronym / sponsor ID
- Mayo4
- Conditions
- Otomycosis
- Keywords
- fungal otitis externa, external auditory canal fungal infection, clotrimazole, salicylic acid, topical treatment, ear blockage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 17 Apr 2026 (actual)
- 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 fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. A total of 60 patients diagnosed with otomycosis were enrolled and were randomly assigned in equal numbers to one of the two treatment groups. One group received clotrimazole drops three times daily for two weeks, while the other group received 2% salicylic acid drops at the same frequency and for the same duration. Patients were assessed at the start of treatment and again after two weeks. The main outcome measure was relief of ear blockage, which reflected improvement in canal patency after treatment. It was hypothesized that topical clotrimazole would be more effective than 2% salicylic acid in clearing ear blockage and improving short-term clinical recovery in patients with otomycosis. This study was conducted to provide evidence for selecting an effective, practical, and affordable topical treatment for routine clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Clotrimazole | Experimental | Drug: clotrimazoleReceived three drops of clotrimazole in the affected ear three times daily for two weeks. |
| Group B 2% Salicylic Acid | Active comparator | Drug: 2% Salicylic AcidReceived three drops of 2% salicylic acid in the affected ear three times daily for two weeks. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients of both genders
- Age 5 to 60 years
- Patients having confirmed diagnosis of otomycosis
Key exclusion criteria (7 listed)
- Chronic suppurative otitis media
- Other ear pathologies
- Immunodeficiency
- Diabetes mellitus
- Receiving steroids
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 |
|---|---|---|
| clotrimazoleThree drops of clotrimazole were administered in the affected ear three times daily for two weeks. | Drug | Group A Clotrimazole |
| 2% Salicylic AcidThree drops of 2% salicylic acid were administered in the affected ear three times daily for two weeks. | Drug | Group B 2% Salicylic Acid |
Primary outcome
Resolution of ear blockage
Time frame: 2 weeks after initiation of treatment.
Ear blockage was assessed clinically as present or absent in the affected ear. The primary outcome measure was the proportion of patients who achieved absence of ear blockage after treatment, reflecting restoration of external auditory canal patency. The assessment was performed by the same ENT consultant in both treatment groups.
1 secondary outcome
Clearance of fungal debris
Time frame: 2 weeks after initiation of 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 17 Apr 2026.
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.
Muhammad Hasnain principal investigator
Mayo Hospital Lahore
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 2% Salicylic Acid in people with Otomycosis, run by Mayo Hospital Lahore at 1 site in Pakistan.
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 17 Apr 2026. 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 Pakistan. 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?
Resolution of ear blockage (time frame: 2 weeks after initiation of 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 17 Apr 2026.