Clinical trial NCT06085443: Safety and Effectiveness of an Auricular Spray
Official title: Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Ear Wax
Lead sponsor: YSLab
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 101
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Skin irritation
timeFrame: Day0 and Day90
Secondary outcomes:
measure: Ear canal obstruction due to excessive earwax
timeFrame: Day0 and Day90
measure: Hearing threshold
timeFrame: Day0 and Day90
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Eurofins Dermscan Poland
state: Ul. Matuszewskiego 12
Study officials:
affiliation: Eurofins Dermscan
name: Iwona MAZUREWICZ
role: PRINCIPAL_INVESTIGATOR
References: