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

Otomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04824261
• Other study ID #: otomycosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Maria H. Kamal
• Phone: +201275589149
• Email: dr.m.hosny.ent[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Otomycosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Ho T, Vrabec JT, Yoo D, Coker NJ. Otomycosis: clinical features and treatment implications. Otolaryngol Head Neck Surg. 2006 Nov;135(5):787-91. — View Citation

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

Mugliston T, O'Donoghue G. Otomycosis--a continuing problem. J Laryngol Otol. 1985 Apr;99(4):327-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Curative rate of otomycosis		1 month