Safety and Effectiveness of an Auricular Spray

NCT06085443 | Completed Results

• 1 other identifier: 23E1670
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Ear Wax

Outcome Measures

Primary Outcomes (1)

• Skin Irritation

  To confirm the safety of the device by clinical examination by ENT specialist and scoring of the irritation of the ear canal at Day90 in comparison with basal scoring of irritation at Day0 such as: * 0: no irritation, * 1: slight irritation (located slight erythema and/or dryness), * 2: moderate irritation (clear erythema or dryness which may be visible on the whole treated area), * 3: severe irritation (serious erythema with potential oedema and/or scar).

  Day0 and Day90

Secondary Outcomes (2)

• Ear Canal Obstruction Due to Excessive Earwax

  Day0 and Day90

• Hearing Function

  Day0 and Day90

Study Arms (2)

Auricular spray

EXPERIMENTAL

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

Other: Ear Hygiene

Control

NO INTERVENTION

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

Interventions

Ear Hygiene OTHER

2 sprays in each ear, every 3 days at home

Auricular spray

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: female and/or male.
• Age:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YSLab: lead

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, Ul. Matuszewskiego 12, 80-288, Poland

Location

Results Point of Contact

• Title: Mélody DUTOT
• Organization: YSLAB

melody.dutot@yslab.fr

33 (0)2.98.53.30.03

Study Officials

• Iwona MAZUREWICZ

  Eurofins Dermscan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: February 6, 2024
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)