OtomycosisPhase 1NCT06339294
Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment
A Phase 1 study testing Clotrimazole Cream and Povidone-Iodine in people with Otomycosis, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment. Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Otomycosis
- What is being tested?
- Clotrimazole Cream and Povidone-Iodine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jun 2023to 31 Dec 2023
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with clinical diagnosis of otomycosis via otoscopy
Who cannot join
- Active CSOM
- External auditory canal abnormalities
- Patients on hearing aids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial
Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.
Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14.
Read the detailed description
INTRODUCTION:
Otomycosis, external auditory canal fungal infection is a recurrent and prevalent condition affecting 9%to 27.2% of patients worldwide. Use of topical antibiotics, humid conditions, and trauma to the external auditory canal are well-recognized risk factors for this disease. Aspergillus nigar (60-90%), and Candida species (10-40%) are the most commonly isolated pathogens in patients with otomycosis. Otomycosis presents with bothersome symptoms such as pruritis, watery ear discharge, otalgia, and ear blockage which significantly impairs the patient's quality of life Therapeutic approaches for fungal ear infections include aural toilet, withholding topical antibiotics, starting topical antifungals, and enhancing patient well-being and cleanliness Multiple treatment options are available for the treatment of otomycosis but the recurrence rate of the disease is high. While several antifungal agents have been employed for its treatment, due to a lack of efficacy comparison it is difficult to select an appropriate option The choice of therapy plays an important role in achieving rapid symptom resolution and complete fungal eradication. Clotrimazole, a conventional antifungal agent, has been widely employed, but its efficacy is not always optimal. For topical treatment compliance of the patient and proper application of medication is also an important factor affecting the efficacy of the drug. Conversely, the utilization of pyodine-soaked Gelfoam is a novel approach that offers several advantages, including sustained drug release better drug penetration, and decreased risk of resistance as in the case of antifungals.
Due to reduced compliance of the patients and ineffective technique of using topical antifungal otomycosis has a high rate of treatment failure and recurrence. Topical clotrimazole drops and povidine iodine solution have been compared for their efficacy in the past but a single topical application has not been compared until now. In this pursuit, we present a rigorous and comprehensive clinical trial designed to evaluate the comparative efficacy of two distinct treatment modalities: pyodine-soaked Gelfoam and a single topical application of 1% clotrimazole. The rationale behind this study is to address the escalating concerns regarding treatment-resistant otomycosis, as well as the need for cost-effective and practical solutions By addressing the question of which treatment is superior, this study endeavors to optimize the management of otomycosis, ensuring better patient outcomes and reduced healthcare costs.
MATERIAL \& METHODS:
The main objective of this study is to evaluate the effectiveness of povidone iodine-soaked gel foam vs clotrimazole ointment in the management of otomycosis. A randomized controlled study was done in the ENT Department of Benazir Bhutto Hospital Rawalpindi over a period of 6 months from June 2023 to December 2023.
Individuals with a clinical otomycosis diagnosis were recruited for the study. Individuals with active CSOM, external auditory canal abnormalities, and hearing aids were excluded from the study. A sample size of 90 patients was calculated. After approval from the ethical review board, patients were selected from the ENT clinic of Benazir Bhutto Hospital and enrolled in two treatment groups after obtaining informed consent. Complete history was taken from the patients and the ear canal was assessed by otoscopy. The aural toilet of all patients was done via suctioning of the ear canal. In Group A patient's ear canal was filled with 1% clotrimazole ointment by using an Intravenous catheter and syringe In Group B pyodine solution-soaked gel foam was placed in the external auditory canal. Followup of patients was done on the 7th and 14th post-treatment days otoscopy was performed and post-treatment symptom resolution and ear canal condition were assessed. Patients were allocated to three groups based on their clinical outcomes
Good response Patients with a dry EAC and tympanic membrane intact
Partial Response:
Patients with scanty discharge but not completely dry EAC
No Response:
Patients with unusually high EAC Exudation
- Conditions
- Otomycosis
- Being tested
- Clotrimazole Cream, Povidone-Iodine
- Keywords
- Otomycosis, clotrimazole ointment, povidone iodine
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole CreamDrug
Single time application of clotrimazole ointment was done after aural toilet in external auditory canal via IV catheter
Povidone-IodineDrug
Gelfoam soaked pyodine solution was placed in external auditory canal after aural toilet
| Study group | Role | What they receive |
|---|---|---|
| Group A (clotrimazole ointment group) | Experimental | Clotrimzole ointment
1ml dose Frequency one time application Duration one time application with aural toilet after 7 days Receives: Drug: Clotrimazole Cream |
| Group B(Povidone Iodine group) | Experimental | Povidone iodine solution
1ml dose Frequency one time application Duration one time application with aural toilet after 7 days Receives: Drug: Povidone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response Based on Otoscopy
Good response Patients with a dry EAC and tympanic membrane intact with no fungal spores
Partial Response:
Patients with scanty discharge but not completely dry EAC with no fungal spores
No Response:
Patients with unusually high EAC Exudation with fungal spores present
Measured: 7th and 14th post treatment day
Secondary outcomes (1)
Condition of External Auditory Canal
Condition of External Auditory canal will be assessed via otoscop External auditory canal edema and erythema: Present or not Tympanic membrane congestion: Present or not Purulent discharge: Present or Not
Measured: 7th and 14th post treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start16 Jun 2023
- Primary completion15 Dec 2023
- Study completion31 Dec 2023
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zuneera Shabbir, Rawalpindi Medical College
- Investigators
- Zuneera Shabbir PGR, MBBS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339294
- Sponsor's protocol ID
- ZShabbir
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jwery AK. Various topical antifungal agents in otomycosis, which is the best? J Pak Med Assoc. 2021 Dec;71(Suppl 8)(12):S32-S34.
PubMed 35130214Haq M, Deshmukh P. Review of Recurrent Otomycosis and Clotrimazole in Its Treatment. Cureus. 2022 Oct 9;14(10):e30098. doi: 10.7759/cureus.30098. eCollection 2022 Oct.
PubMed 36381881Chavan RP, Ingole SM, Kanchewad Resident GS. Single Topical Application of 1% Clotrimazole Cream in Otomycosis. Indian J Otolaryngol Head Neck Surg. 2023 Apr;75(Suppl 1):147-154. doi: 10.1007/s12070-022-03206-x. Epub 2022 Dec 8.
PubMed 36532230
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Treatment of Otomycosis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06339294
- Acronym / sponsor ID
- ZShabbir
- Conditions
- Otomycosis
- Keywords
- Otomycosis, clotrimazole ointment, povidone iodine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Apr 2024 (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.
Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.
Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14.
Detailed description
INTRODUCTION:
Otomycosis, external auditory canal fungal infection is a recurrent and prevalent condition affecting 9%to 27.2% of patients worldwide. Use of topical antibiotics, humid conditions, and trauma to the external auditory canal are well-recognized risk factors for this disease. Aspergillus nigar (60-90%), and Candida species (10-40%) are the most commonly isolated pathogens in patients with otomycosis. Otomycosis presents with bothersome symptoms such as pruritis, watery ear discharge, otalgia, and ear blockage which significantly impairs the patient's quality of life Therapeutic approaches for fungal ear infections include aural toilet, withholding topical antibiotics, starting topical antifungals, and enhancing patient well-being and cleanliness Multiple treatment options are available for the treatment of otomycosis but the recurrence rate of the disease is high. While several antifungal agents have been employed for its treatment, due to a lack of efficacy comparison it is difficult to select an appropriate option The choice of therapy plays an important role in achieving rapid symptom resolution and complete fungal eradication. Clotrimazole, a conventional antifungal agent, has been widely employed, but its efficacy is not always optimal. For topical treatment compliance of the patient and proper application of medication is also an important factor affecting the efficacy of the drug. Conversely, the utilization of pyodine-soaked Gelfoam is a novel approach that offers several advantages, including sustained drug release better drug penetration, and decreased risk of resistance as in the case of antifungals.
Due to reduced compliance of the patients and ineffective technique of using topical antifungal otomycosis has a high rate of treatment failure and recurrence. Topical clotrimazole drops and povidine iodine solution have been compared for their efficacy in the past but a single topical application has not been compared until now. In this pursuit, we present a rigorous and comprehensive clinical trial designed to evaluate the comparative efficacy of two distinct treatment modalities: pyodine-soaked Gelfoam and a single topical application of 1% clotrimazole. The rationale behind this study is to address the escalating concerns regarding treatment-resistant otomycosis, as well as the need for cost-effective and practical solutions By addressing the question of which treatment is superior, this study endeavors to optimize the management of otomycosis, ensuring better patient outcomes and reduced healthcare costs.
MATERIAL \& METHODS:
The main objective of this study is to evaluate the effectiveness of povidone iodine-soaked gel foam vs clotrimazole ointment in the management of otomycosis. A randomized controlled study was done in the ENT Department of Benazir Bhutto Hospital Rawalpindi over a period of 6 months from June 2023 to December 2023.
Individuals with a clinical otomycosis diagnosis were recruited for the study. Individuals with active CSOM, external auditory canal abnormalities, and hearing aids were excluded from the study. A sample size of 90 patients was calculated. After approval from the ethical review board, patients were selected from the ENT clinic of Benazir Bhutto Hospital and enrolled in two treatment groups after obtaining informed consent. Complete history was taken from the patients and the ear canal was assessed by otoscopy. The aural toilet of all patients was done via suctioning of the ear canal. In Group A patient's ear canal was filled with 1% clotrimazole ointment by using an Intravenous catheter and syringe In Group B pyodine solution-soaked gel foam was placed in the external auditory canal. Followup of patients was done on the 7th and 14th post-treatment days otoscopy was performed and post-treatment symptom resolution and ear canal condition were assessed. Patients were allocated to three groups based on their clinical outcomes
Good response Patients with a dry EAC and tympanic membrane intact
Partial Response:
Patients with scanty discharge but not completely dry EAC
No Response:
Patients with unusually high EAC Exudation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (clotrimazole ointment group) | Experimental | Drug: Clotrimazole CreamClotrimzole ointment 1ml dose Frequency one time application Duration one time application with aural toilet after 7 days |
| Group B(Povidone Iodine group) | Experimental | Drug: Povidone-IodinePovidone iodine solution 1ml dose Frequency one time application Duration one time application with aural toilet after 7 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with clinical diagnosis of otomycosis via otoscopy
Key exclusion criteria (3 listed)
- Active CSOM
- External auditory canal abnormalities
- Patients on hearing aids
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 |
|---|---|---|
| Clotrimazole CreamSingle time application of clotrimazole ointment was done after aural toilet in external auditory canal via IV catheter | Drug | Group A (clotrimazole ointment group) |
| Povidone-IodineGelfoam soaked pyodine solution was placed in external auditory canal after aural toilet | Drug | Group B(Povidone Iodine group) |
Primary outcome
Treatment Response Based on Otoscopy
Time frame: 7th and 14th post treatment day
Good response Patients with a dry EAC and tympanic membrane intact with no fungal spores Partial Response: Patients with scanty discharge but not completely dry EAC with no fungal spores No Response: Patients with unusually high EAC Exudation with fungal spores present
1 secondary outcome
Condition of External Auditory Canal
Time frame: 7th and 14th post treatment day
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 1 Apr 2024.
- Background: PubMed 35130214Jwery AK. Various topical antifungal agents in otomycosis, which is the best? J Pak Med Assoc. 2021 Dec;71(Suppl 8)(12):S32-S34.
- Background: PubMed 36381881Haq M, Deshmukh P. Review of Recurrent Otomycosis and Clotrimazole in Its Treatment. Cureus. 2022 Oct 9;14(10):e30098. doi: 10.7759/cureus.30098. eCollection 2022 Oct.
- Results publication: PubMed 36532230Chavan RP, Ingole SM, Kanchewad Resident GS. Single Topical Application of 1% Clotrimazole Cream in Otomycosis. Indian J Otolaryngol Head Neck Surg. 2023 Apr;75(Suppl 1):147-154. doi: 10.1007/s12070-022-03206-x. Epub 2022 Dec 8.
- 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.
Zuneera Shabbir PGR, MBBS principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clotrimazole Cream and Povidone-Iodine in people with Otomycosis, run by Rawalpindi Medical College at 1 site in Pakistan.
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 3 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 1 Apr 2024. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment Response Based on Otoscopy (time frame: 7th and 14th post treatment day). 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 NCT06339294, 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 1 Apr 2024.