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Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.

Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04824261
Enrollment
100
Registered
2021-04-01
Start date
2021-06-01
Completion date
2023-06-01
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otomycosis

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.

Interventions

DRUGClotrimazol solution 1%

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.

DRUG4%boric acid in distilled water

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Curative rate of otomycosis1 month

Contacts

Primary ContactMaria H. Kamal
dr.m.hosny.ent@gmail.com+201275589149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026