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

NCT ID: NCT04824261

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-06-01

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.

Conditions

Otomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1

randomized 50 otomycosis patients will receive Clotrimazol solution 1%

Group Type: ACTIVE_COMPARATOR

Clotrimazol solution 1%

Intervention Type: 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 2

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

Group Type: ACTIVE_COMPARATOR

4%boric acid in distilled water

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Maria Hosny Kamal Gendi

resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maria H. Kamal

Role: CONTACT

dr.m.hosny.ent@gmail.com

+201275589149

References

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.

Reference Type: BACKGROUND

PMID: 17071313 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 4009029 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10969470 (View on PubMed)

Other Identifiers

otomycosis

Identifier Type: -

Identifier Source: org_study_id