Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis

April 10, 2026 updated by: Adeel Ahmed, Mayo Hospital Lahore
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Mayo Hospital, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both genders
  • Age 5 to 60 years
  • Patients having confirmed diagnosis of otomycosis

Exclusion Criteria:

  • Chronic suppurative otitis media
  • Other ear pathologies
  • Immunodeficiency
  • Diabetes mellitus
  • Receiving steroids
  • Receiving chemotherapy
  • Receiving radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A Clotrimazole
Received three drops of clotrimazole in the affected ear three times daily for two weeks.
Drug: clotrimazole
Three drops of clotrimazole were administered in the affected ear three times daily for two weeks.
Active Comparator: Group B 2% Salicylic Acid
Received three drops of 2% salicylic acid in the affected ear three times daily for two weeks.
Drug: 2% Salicylic Acid
Three drops of 2% salicylic acid were administered in the affected ear three times daily for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks after initiation of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of fungal debris
Time Frame: 2 weeks after initiation of treatment.
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 .
2 weeks after initiation of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Hospital Lahore

Investigators

  • Principal Investigator: Muhammad Hasnain, Mayo Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mayo4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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