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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07535424
Enrollment
60
Registered
2026-04-17
Start date
2024-11-20
Completion date
2025-10-20
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otomycosis

Keywords

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

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.

Interventions

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.

Sponsors

Mayo Hospital Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of ear blockage2 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

MeasureTime frameDescription
Clearance of fungal debris2 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 .

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORMuhammad Hasnain

Mayo Hospital Lahore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026