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Completed

NCT Number: NCT07535424

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

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.

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Key information

Conditions

Otomycosis Bacterial Infections and Mycoses Ear Diseases Infections Mycoses Otorhinolaryngologic Diseases

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clotrimazole

Drug

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

2% Salicylic Acid

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 .

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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