Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis

Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis: a Randomized Clinical Trial

This study compares two topical agents for the treatment of fungal infection of the external auditory canal: boric acid and a 10% povidone-iodine solution

Study Overview

• Status: Completed
• Conditions: Otomycosis
• Intervention / Treatment: Drug: Boric acid; Drug: Povidone iodine 10%

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Al Mansurah, Dakahlia Governorate, Egypt, 35511
      • Faculty of Medicine, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all consecutive patients with otomycosis, recruited from the outpatient clinic during the study duration

Exclusion Criteria:

• tympanic membrane perforation
• previous ear surgery
• significant medical co-morbidities such as poorly controlled diabetes or immunocompromised patients
• patient refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Boric acid group	Drug: Boric acid; Boric acid is topically applied to the external auditory canal for treatment of otomycosis
Active Comparator: Povidone iodine group	Drug: Povidone iodine 10%; 10% povidone iodine solution is topically applied to the external auditory canal for the treatment of otomycosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective clinical response	clinical response is assessed by ear examination by presence or absence of fungal hyphae inside the external auditory canal	Days 7, 14, and 28 after treatment
Microbiological response	Microbiological response is evaluated by obtaining cultures from the external auditory canal searching for fungal growth	day 28 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective pain response	pain is evaluated on a visual analogue scale from 0 to 10	days 7, 14, and 28 after treatment
subjective itching response	itching is evaluated on a visual analogue scale from 0 to 10	days 7, 14, and 28 after treatment

Collaborators and Investigators

• Sponsor: Mansoura University

Publications and helpful links

General Publications

• Philip A, Thomas R, Job A, Sundaresan VR, Anandan S, Albert RR. Effectiveness of 7.5 percent povidone iodine in comparison to 1 percent clotrimazole with lignocaine in the treatment of otomycosis. ISRN Otolaryngol. 2013 Jul 25;2013:239730. doi: 10.1155/2013/239730. eCollection 2013.
• Mofatteh MR, Naseripour Yazdi Z, Yousefi M, Namaei MH. Comparison of the recovery rate of otomycosis using betadine and clotrimazole topical treatment. Braz J Otorhinolaryngol. 2018 Jul-Aug;84(4):404-409. doi: 10.1016/j.bjorl.2017.04.004. Epub 2017 May 6.
• del Palacio A, Cuetara MS, Lopez-Suso MJ, Amor E, Garau M. Randomized prospective comparative study: short-term treatment with ciclopiroxolamine (cream and solution) versus boric acid in the treatment of otomycosis. Mycoses. 2002 Oct;45(8):317-28. doi: 10.1046/j.1439-0507.2002.00737.x.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otomycosis; boric acid
• Other Study ID Numbers: MS.24.12.3007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No