N/A
N=99
Safety and Effectiveness of an Auricular Spray
Excessive Ear Wax
Bottom Line
View on ClinicalTrials.gov: NCT06085443 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Skin Irritation — 0.22; 0.20; 0.13; 0.11 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ear Hygiene (Other)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- YSLab
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Irritation |
0.22; 0.20; 0.13; 0.11 | — |
| SECONDARY Ear Canal Obstruction Due to Excessive Earwax |
2.33; 2.29; 1.19; 1.97 | — |
| SECONDARY Hearing Function |
1.07; 0.26 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06085443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.