NCT04824261

Brief Summary

Otomycosis is a fungal infection that affects one, or occasionally both, of the ears. It mostly affects people who live in warm or tropical areas. It also often affects people who swim frequently, live with diabetes, or have other chronic medical and skin conditions. It is a pathologic entity, with candida and aspergillus the most common fungal species. \]Various predisposing factors include a humid climate, presence of cerumen, instrumentation of the ear, increased use of topical antibiotics / steroid preparations, immune-compromised host, patients who have undergone open cavity mastoidectomy and those who wear hearing aids with occlusive ear mold. The infection is usually unilateral and characterized by inflammatory pruritis, scaling and otalgia.Treatment recommendations have included local debridement, local and systemic antifungal agents and discontinuation of topical antibiotics. Sometimes otomycosis presents as a challenging disease for its long term treatment and follow up, yet its recurrence rate remains high. According to Thai National List of essential medicines for topical antifugal agents are:

  • acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)
  • boric acid (4% in distilled water)
  • gentian violet
  • clotrimazole ear drop. Some fungal infections such as Aspergillus may be resistant to the usual ear drops. They may require oral medications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 27, 2021

Last Update Submit

March 27, 2021

Conditions

Otomycosis

Outcome Measures

Primary Outcomes (1)

  • Curative rate of otomycosis

    1 month

Study Arms (2)

group 1

ACTIVE COMPARATOR

randomized 50 otomycosis patients will receive Clotrimazol solution 1%

Drug: Clotrimazol solution 1%

group 2

ACTIVE COMPARATOR

randomized 50 otomycosis patients will receive 4%boric acid in distilled water

Drug: 4%boric acid in distilled water

Interventions

Clotrimazol solution 1%DRUG

50 otomycosis randomized patients will receive Clotrimazol solution 1% The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.

group 1
4%boric acid in distilled waterDRUG

50 otomycosis randomized patients will receive 4%boric acid in distilled water The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.

group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic otomycosis.
  • Microscopic direct examination and/or culture positive for fungus.

You may not qualify if:

  • During usage of systemic antifungal drug
  • Allergic to 4% boric acid in distilled water or clotrimazole solution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ho T, Vrabec JT, Yoo D, Coker NJ. Otomycosis: clinical features and treatment implications. Otolaryngol Head Neck Surg. 2006 Nov;135(5):787-91. doi: 10.1016/j.otohns.2006.07.008.

    PMID: 17071313BACKGROUND

  • Mugliston T, O'Donoghue G. Otomycosis--a continuing problem. J Laryngol Otol. 1985 Apr;99(4):327-33. doi: 10.1017/s002221510009678x.

    PMID: 4009029BACKGROUND

  • Kaur R, Mittal N, Kakkar M, Aggarwal AK, Mathur MD. Otomycosis: a clinicomycologic study. Ear Nose Throat J. 2000 Aug;79(8):606-9.

    PMID: 10969470BACKGROUND

MeSH Terms

Conditions

Otomycosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Maria H. Kamal

CONTACT

+201275589149dr.m.hosny.ent@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

June 1, 2021

Primary Completion

May 31, 2022

Study Completion

June 1, 2023

Last Updated

April 1, 2021

Record last verified: 2021-03