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CompletedNCT07295210Updated Dec 26, 2025

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

An interventional study of Boric acid and Povidone iodine 10% in Otomycosis, sponsored by Mansoura University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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

02

Conditions studied

  • Otomycosis
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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

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

Exclusion criteria

Exclusion Criteria:

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

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Boric acid group

    Drug: Boric acid

  • Active comparator
    Povidone iodine group

    Drug: Povidone iodine 10%

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. objective clinical response

    clinical response is assessed by ear examination by presence or absence of fungal hyphae inside the external auditory canal

    Time frame: Days 7, 14, and 28 after treatment

  2. Microbiological response

    Microbiological response is evaluated by obtaining cultures from the external auditory canal searching for fungal growth

    Time frame: day 28 after treatment

Secondary outcomes

  1. subjective pain response

    pain is evaluated on a visual analogue scale from 0 to 10

    Time frame: days 7, 14, and 28 after treatment

  2. subjective itching response

    itching is evaluated on a visual analogue scale from 0 to 10

    Time frame: days 7, 14, and 28 after treatment

07

Study locations

1 site
  • Faculty of Medicine, Mansoura University
    Al Mansurah, Dakahlia Governorate 35511, Egypt
08

References and documents

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. PubMed 23984100 ↗
  • 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. PubMed 28549873 ↗
  • 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. PubMed 12572722 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2024 to primary completion in Dec 2025, 12 months.

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

Registered
Dec 8, 2025
First posted
Dec 19, 2025
StartActual
Dec 1, 2024
Primary completionActual
Dec 1, 2025
CompletionActual
Dec 1, 2025
Last update
Dec 26, 2025
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 Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07295210
Responsible party
Sponsor
First posted
Dec 19, 2025
Start date
Dec 1, 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Dec 26, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Boric acid · Povidone-Iodine

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