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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

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2024, registered Apr 2026).
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

In context

Lead sponsor

Mayo Hospital Lahore is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Receiving chemotherapy
  • Receiving radiotherapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

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

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

06

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.

07

Study locations

1 site
  • Mayo Hospital, Lahore
    Lahore, Punjab Province 54000, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2024 to primary completion in Oct 2025, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2026
First posted
Apr 17, 2026
StartActual
Nov 20, 2024
Primary completionActual
Oct 20, 2025
CompletionActual
Oct 20, 2025
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clotrimazole

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