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

NCT04824261 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

  • Otomycosis

Interventions

DRUG

Clotrimazol 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.

DRUG

4%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 & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-05-31
Completion
2023-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824261 on ClinicalTrials.gov