Earol Madrid Study begins in Spain

Photo by Gabrielle Henderson

The company HL Healthcare Ltd is commencing recruitment for the clinical trial of the Earol Madrid Study.

The condition is Cerumen Impaction of Both Ears.

A new clinical trial is recruiting patients in the following locations: Spain.

The trial officially began on the December 3, 2019 and is planned to complete on June 30, 2021.

Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear wax 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 ear wax is facilitated using a variety of cerumenolytics, or ear wax solvents. The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product, when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure. This study is designed to be conducted in the primary care setting as a prospective clinical trial.

The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol. Although there are alternative methods for ear wax removal, Earol represents a simple method based on natural ingredients (olive oil) which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal (E.g. reducing itching and irritation).

The population that can be enrolled into this study includes:

• Male or female patients over 18-year-old;
• Presence of ear wax in both ear canals with a minimum of > 50% ear wax blockage in at least one ear (level 4) and > 25% blockage in the contralateral ear (level 3) as assessed using the TMVSS.

Among the excluding conditions appear:

• Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
• Presence or history of a tympanic membrane perforation or tympanostomy tubes at any time during the previous 6 months;
• Presence or history of a known or suspected ear infection (i.e. otitis externa or otitis interna) in the previous 2 months.

   and others.

AKRN Scientific Consulting, S.L is the collaborator in this clinical trial.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04653662