Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Phase 4

Completed

• Conditions: Ear Infection; Vertigo; Hearing Loss
• Interventions: Drug: drops intilation (Taponoto ® ); Drug: drops intilation (Placebo); Drug: drops intilation (Otocerum®)

• Registration Number: NCT00765635
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.

Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.

Detailed Description

INTERVENTIONS: Subjects were randomly assigned to one of three different treatments: Otocerum®; Taponoto ®, and a control group with sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). The test medication was instilled into an occluded ear for 15 minutes. Following this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Last Update Submitted: 2008-10-02
• Study First Posted: 2008-10-03
• Last Update Posted: 2008-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Clinical diagnosis of ear cerumen

Exclusion Criteria

• Infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	drops intilation (Taponoto ® )	Taponoto ® (potassium carbonate 20 mg/1 ml, ethyl alcohol, glycerol 480, thymol 0.4; Teofarma Iberica S.A., Barcelona, Spain),
3	drops intilation (Placebo)	sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain).
1: Chlorobutanol	drops intilation (Otocerum®)	ceruminolytic product, Otocerum® (Chlorobutanol 50 mg/1 ml, phenol 10 mg/1 ml, turpentine essence 0.15 ml/1 ml, ethyl alcohol; Reig Jofre laboratories, Barcelona, Spain),

Primary Outcome Measures

Name	Time	Method
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed	2008

Secondary Outcome Measures

Name	Time	Method
adverse effects	2008

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain