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

NCT07295210 | Completed

• 1 other identifier: MS.24.12.3007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Otomycosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• subjective pain response

  days 7, 14, and 28 after treatment

• subjective itching response

  days 7, 14, and 28 after treatment

Study Arms (2)

Boric acid group

ACTIVE COMPARATOR

Drug: Boric acid

Povidone iodine group

ACTIVE COMPARATOR

Drug: Povidone iodine 10%

Interventions

Boric acid DRUG

Boric acid is topically applied to the external auditory canal for treatment of otomycosis

Boric acid group

Povidone iodine 10% DRUG

10% povidone iodine solution is topically applied to the external auditory canal for the treatment of otomycosis

Povidone iodine group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23984100 RESULT

• 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.

  PMID: 28549873 RESULT

• 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.

  PMID: 12572722 RESULT

MeSH Terms

Conditions

Otomycosis

Interventions

boric acid

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)