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

NCT07535424 | Completed

• 1 other identifier: Mayo4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

fungal otitis externa; external auditory canal fungal infection; clotrimazole; salicylic acid; topical treatment; ear blockage

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks after initiation of treatment.

Secondary Outcomes (1)

• Clearance of fungal debris

  2 weeks after initiation of treatment.

Study Arms (2)

Group A Clotrimazole

EXPERIMENTAL

Received three drops of clotrimazole in the affected ear three times daily for two weeks.

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.

Drug: 2% Salicylic Acid

Interventions

clotrimazole DRUG

Three drops of clotrimazole were administered in the affected ear three times daily for two weeks.

Group A Clotrimazole

2% Salicylic Acid DRUG

Three drops of 2% salicylic acid were administered in the affected ear three times daily for two weeks.

Group B 2% Salicylic Acid

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Otomycosis

Interventions

Clotrimazole; Salicylic Acid

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Muhammad Hasnain

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: November 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

PA (1)