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CompletedNCT07535424Updated Apr 17, 2026

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

An interventional study of clotrimazole and 2% Salicylic Acid in Otomycosis, sponsored by Mayo Hospital Lahore. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Mayo Hospital Lahore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Otomycosis

Keywords

  • fungal otitis externa
  • external auditory canal fungal infection
  • clotrimazole
  • salicylic acid
  • topical treatment
  • ear blockage
03

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic suppurative otitis media
  • Other ear pathologies
  • Immunodeficiency
  • Diabetes mellitus
  • Receiving steroids
  • Receiving chemotherapy
  • Receiving radiotherapy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group A Clotrimazole

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

    Drug: clotrimazole

  • 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

Interventions

  • Drugclotrimazole

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

  • Drug2% Salicylic Acid

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

05

What researchers measure

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.

    Time frame: 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 .

    Time frame: 2 weeks after initiation of treatment.

06

Study locations

1 site
  • Mayo Hospital, Lahore
    Lahore, Punjab Province 54000, Pakistan
07

Registry details

Key details

Study ID
NCT07535424
Lead sponsor
Mayo Hospital Lahore
Responsible party
Adeel Ahmed (Principal Investigator, Mayo Hospital Lahore) — Principal investigator
First posted
Apr 17, 2026
Start date
Nov 20, 2024
Primary completion
Oct 20, 2025
Completion
Oct 20, 2025
Last update
Apr 17, 2026

Study contacts

Muhammad Hasnain
principal investigator · Mayo Hospital Lahore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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