OtomycosisNCT07295210
Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis
A study testing Boric acid and Povidone iodine 10% in people with Otomycosis, run by Mansoura University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otomycosis
- What is being tested?
- Boric acid and Povidone iodine 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all consecutive patients with otomycosis, recruited from the outpatient clinic during the study duration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: 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
- Conditions
- Otomycosis
- Being tested
- Boric acid, Povidone iodine 10%
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boric acidDrug
Boric acid is topically applied to the external auditory canal for treatment of otomycosis
Povidone iodine 10%Drug
10% povidone iodine solution is topically applied to the external auditory canal for the treatment of otomycosis
| Study group | Role | What they receive |
|---|---|---|
| Boric acid group | Active comparator | Not described Receives: Drug: Boric acid |
| Povidone iodine group | Active comparator | Not described Receives: Drug: Povidone iodine 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective clinical response
clinical response is assessed by ear examination by presence or absence of fungal hyphae inside the external auditory canal
Measured: 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
Measured: day 28 after treatment
Secondary outcomes (2)
subjective pain response
pain is evaluated on a visual analogue scale from 0 to 10
Measured: days 7, 14, and 28 after treatment
subjective itching response
itching is evaluated on a visual analogue scale from 0 to 10
Measured: days 7, 14, and 28 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295210
- Sponsor's protocol ID
- MS.24.12.3007
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23984100Mofatteh 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 28549873del 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07295210
- Acronym / sponsor ID
- MS.24.12.3007
- Conditions
- Otomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boric acid group | Active comparator | Drug: Boric acid |
| Povidone iodine group | Active comparator | Drug: Povidone iodine 10% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients with otomycosis, recruited from the outpatient clinic during the study duration
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boric acidBoric acid is topically applied to the external auditory canal for treatment of otomycosis | Drug | Boric acid group |
| Povidone iodine 10%10% povidone iodine solution is topically applied to the external auditory canal for the treatment of otomycosis | Drug | Povidone iodine group |
Primary outcome
objective clinical response
Time frame: Days 7, 14, and 28 after treatment
clinical response is assessed by ear examination by presence or absence of fungal hyphae inside the external auditory canal
Microbiological response
Time frame: day 28 after treatment
Microbiological response is evaluated by obtaining cultures from the external auditory canal searching for fungal growth
2 secondary outcomes
subjective pain response
Time frame: days 7, 14, and 28 after treatment
subjective itching response
Time frame: days 7, 14, and 28 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 23984100Philip 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.
- Results publication: PubMed 28549873Mofatteh 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.
- Results publication: PubMed 12572722del 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.
- Individual participant dataSharing planned: No
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
Not yet recruiting
Terbinafine Hydrochloride for the Treatment of Otomycosis
Otomycosis, Fungal Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boric acid and Povidone iodine 10% in people with Otomycosis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective clinical response (time frame: Days 7, 14, and 28 after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07295210, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.