Safety and Effectiveness of an Auricular Spray

NCT ID: NCT06085443

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2024-07-24

Brief Summary

The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are:

• Does the medical device induce skin irritation in the ear canal?
• Does the medical device reduce obstruction of ear canal induced by excessive cerumen?

Participants will use the device in each ear, once a day, every 3 days at home. Researchers will compare the medical device group to a control group who will not use the medical device.

Detailed Description

Ocean Bio Actif Hygiène de l'oreille is a medical device class IIa indicated for the prevention of the formation of earwax plugs and consequently the pathologies linked to the accumulation of earwax (hearing loss and infection/affection of the external auditory canal).

This clinical investigation is designed to improve the quality and quantity of data available on both the safety and the efficacy of Ocean Bio-Actif, in order to confirm the safety and the efficacy of the product in a post-market environment.

The objective of the current clinical investigation is to confirm the efficacy and safety of topical application to the ear canal of Ocean Bio-Actif.

Conditions

Excessive Ear Wax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Auricular spray

Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.

Group Type: EXPERIMENTAL

Ear Hygiene

Intervention Type: OTHER

2 sprays in each ear, every 3 days at home

Control

Subjects not using any spray (can use ear drops in case of discomfort or pain)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ear Hygiene

2 sprays in each ear, every 3 days at home

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gender: female and/or male.
• Age:

30 to 40% having age between 3 to 12 yo, 30 to 40% between 13 to 65 yo, 30 to 40% more than 65 yo.

• Subjects able to use the tested product.
• Subjects having history of cerumen occlusion more than once a year with or without symptoms (reduction of hearing function, obstruction feeling of the ear canal,..).
• Subjects having ear help system or regular users of systems such as anti-noise plugs or headsets (only for the 13yo subjects and more).
• Subjects having a clinical score of ear canal obstruction of 2 or 3 at D0.

Exclusion Criteria

• Subjects who had chirurgical act on the mastoïde.
• Subjects who had severe troubles of the internal ear (severe dizziness, desorientation, nausea).
• Subjects using regularly a ear spray for washing his/her ears.
• Subjects having a score of ear canal obstruction at 4 at D0.
• Pregnant or nursing woman or planning a pregnancy during the study;
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
• Subject in a social or sanitary establishment;
• Subject suspected to be non-compliant according to the investigator's judgment;
• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
• Subject suffering from a severe or progressive disease.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

YSLab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iwona MAZUREWICZ

Role: PRINCIPAL_INVESTIGATOR

Eurofins Dermscan

Locations

Eurofins Dermscan Poland

Gdansk, Ul. Matuszewskiego 12, Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23E1670

Identifier Type: -

Identifier Source: org_study_id