Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients

NCT01547221 | Completed DMC

• 1 other identifier: KKH24-01-2555
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Otomycosis is a superficial fungal infection of the external ear canal. Patients should be treated with cleaning fungal debris combined with topical antifungal agent. There is wide range of topical antifungal agents. However, there is still no consensus of the most effective topical antifungal agents in treatment otomycosis is still lacking. 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 (3% in isopropyl alcohol)
• gentian violet
• clotrimazole ear drop. But from literature review, there is no comparative study between boric acid and clotrimazole solution before. Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.

Conditions

Otomycosis

Keywords

otomycosis; 3% boric acid; 1% clotrimazole ear drop

Outcome Measures

Primary Outcomes (1)

• result as cure rate of otomycosis

  otolaryngologist's microscopic finding

  1 week after treatment

Secondary Outcomes (1)

• adverse effect of treatment

  Five minutes after apply treatment

Study Arms (2)

3% boric acid

ACTIVE COMPARATOR

control

Drug: 3% Boric acid

1% clotrimazole ear drop

EXPERIMENTAL

3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.

Drug: clotrimazole

Interventions

clotrimazole DRUG

single application of 1%clotrimazole ear drop

Also known as: Candid

1% clotrimazole ear drop

3% Boric acid DRUG

3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital

3% boric acid

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic otomycosis, age more than 7 year.
• Microscopic finding revealed fungus
• KOH smear positive for fungus

You may not qualify if:

• Pregnancy
• Tympanic membrane perforation and post mastoid surgery
• Co-infection of ear e.g. severe otitis externa, severe myringitis which are needed other medications
• Previous using topical antibiotic / steroid within 2weeks.
• During usage of systemic antifungal drug
• Allergic to 3% boric acid in70% alcohol or 1% clotrimazole solution.
• Those who can not come to follow up after one week of the treatment

Sponsors & Collaborators

• Khon Kaen Hospital: lead

Study Sites (1)

ENT clinic KhonKaen Hospital

KhonKaen, KhonKaen, 40000, Thailand

Location

MeSH Terms

Conditions

Otomycosis

Interventions

Clotrimazole; boric acid

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sarisa Romsaithong, M.D.

  Unaffiliate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical physician, senior professional level

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

TH (1)