Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-28 @ 2:18 PM
Study NCT ID:
NCT04824261
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: