Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment

NCT06339294 | Completed Phase 1 DMC

• 1 other identifier: ZShabbir
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Otomycosis

Keywords

Otomycosis; clotrimazole ointment; povidone iodine

Outcome Measures

Primary Outcomes (1)

• 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

  7th and 14th post treatment day

Secondary Outcomes (1)

• Condition of External Auditory Canal

  7th and 14th post treatment day

Study Arms (2)

Group A (clotrimazole ointment group)

EXPERIMENTAL

Clotrimzole ointment 1ml dose Frequency one time application Duration one time application with aural toilet after 7 days

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

Drug: Povidone-Iodine

Interventions

Clotrimazole Cream DRUG

Single time application of clotrimazole ointment was done after aural toilet in external auditory canal via IV catheter

Group A (clotrimazole ointment group)

Povidone-Iodine DRUG

Gelfoam soaked pyodine solution was placed in external auditory canal after aural toilet

Group B(Povidone Iodine group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with clinical diagnosis of otomycosis via otoscopy

You may not qualify if:

• Active CSOM
• External auditory canal abnormalities
• Patients on hearing aids

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab/46000, 46000, Pakistan

Location

Related Publications (3)

• Jwery AK. Various topical antifungal agents in otomycosis, which is the best? J Pak Med Assoc. 2021 Dec;71(Suppl 8)(12):S32-S34.

  PMID: 35130214 BACKGROUND

• Haq 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.

  PMID: 36381881 BACKGROUND

• Chavan 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.

  PMID: 36532230 RESULT

MeSH Terms

Conditions

Otomycosis

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Zuneera Shabbir PGR, MBBS

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 1, 2024
• Study Start: June 16, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)