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Comparison of effectiveness between topical 2% Acetic acid and 1% Clotrimazole drops in Otomycosis patients

Comparison of effectiveness between topical 2% Acetic acid and 1% Clotrimazole drops in Otomycosis patients: A prospective single blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251029002
Enrollment
54
Registered
2025-10-29
Start date
2025-11-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients with otomycosis Otomycosis

Interventions

Applying 2% Acetic acid to the ear canal by the investigator, coating all areas of the canal up to the tympanic membrane on day0, 3, 7, 14,1%Clotrimazole ear drops 4 drops into affected ear 3 times da
Experimental Drug,Active Comparator Drug
Topical 2% Acetic Acid,1% Clotrimazole Ear drops

Sponsors

Faculty of Medicine, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years 2. Patients diagnosed with Otomycosis(from symptoms and physical examination) 3. Patient who agrees to participate in the study after receiving a full explanation of the research details and signing the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with perforated tympanic membrane/chronic otitis media 2. Patients with a history of Canal wall down mastoidectomy 3. Patients with a history of allergy to topical ear drops medication 4. Patients with a history of treatment otomycosis within the past 3 months 5. Patients with severe symptoms of otomycosis, with marked swelling of the external auditory canal obscuring more than half of tympanic membrane

Design outcomes

Primary

MeasureTime frame
Resolution of Otomycosis 3 days, 7 days, 14 days Evaluated by research advisor

Secondary

MeasureTime frame
Adverse effects from topical 2% Acetic acid and 1% Clotrimazole ear drops 3 days, 7 days, 14 days Symptoms reported by the participants and determined by the investigator to be drug-related adverse effects,Causative organisms of Otomycosis within 14 days identified from fungal and bacterial cultures of patients,Prevalence of concurrent bacterial infection in patients with otomycosis Within 14 days bacterial cultures

Countries

Thailand

Contacts

Public ContactPornpawee Watjanarat

Khon Kaen University

Pornwat@kku.ac.th0826195351

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026