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NCT04824261
Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
NA trial testing Clotrimazol solution 1% in Otomycosis in 100 participants. Status unknown.
31 May 2022
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 June 2021 |
| Primary completion | 31 May 2022 |
| Estimated completion | 1 June 2023 |
Drugs / interventions tested
- Clotrimazol solution 1% — full drug profile →
- 4%boric acid in distilled water — full drug profile →
Conditions studied
- Otomycosis — all drugs for Otomycosis →
Sponsor
Assiut University
Who can join
Eligibility, any sex, with Otomycosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04824261
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Related trials
Other recruiting trials for Otomycosis
Currently open trials in the same condition.
- NCT06530069 — Exploring the Risk Factors of Otomycosis: A Case-Control Study · recruiting
Other Assiut University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04824261 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assiut University
- Last refreshed: 1 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04824261.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing