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Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00765635
Enrollment
90
Registered
2008-10-03
Start date
2008-09-30
Completion date
Unknown
Last updated
2008-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear Infection, Hearing Loss, Vertigo

Keywords

complete occlusion of the ear canal due to cerumen

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.

Interventions

DRUGdrops intilation (Taponoto ® )

four drops, unique doses

DRUGdrops intilation (Otocerum®)

four drops, unique doses

DRUGdrops intilation (Placebo)

Placebo

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of ear cerumen

Exclusion criteria

* Infection

Design outcomes

Primary

MeasureTime frame
proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed2008

Secondary

MeasureTime frame
adverse effects2008

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026