Excessive Ear WaxNCT06085443
Safety and Effectiveness of an Auricular Spray
A study testing Ear Hygiene in people with Excessive Ear Wax, run by YSLab at 1 site in Poland.
Trial 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?… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Excessive Ear Wax
- What is being tested?
- Ear Hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 sitePoland
- Study dates
- 6 Feb 2024to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene
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.
Read the 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
- Being tested
- Ear Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear HygieneOther
2 sprays in each ear, every 3 days at home
| Study group | Role | What they receive |
|---|---|---|
| Auricular spray | Experimental | Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home. Receives: Other: Ear Hygiene |
| Control | No intervention | Subjects not using any spray (can use ear drops in case of discomfort or pain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day0 and Day90
Secondary outcomes (2)
Ear Canal Obstruction Due to Excessive Earwax
To confirm the efficacy/performance of the device for the prevention of ear obstruction in comparison to baseline (Day0) and between groups using the scoring of the obstruction of ear canal by the Investigator:
0: no obstruction - normal and/or no significant presence of cerumen in the ear canal. The membrane is clearly visible.
- <25% minimal, very little and mostly insignificant impacted cerumen. The tympanic membrane is visible, but with still a little bit cerumen.
- 25-50% mild, some excessive impacted cerumen causing partial occlusion of the ear canal. The tympanic membrane is not entirely visible, quite difficult to see.
- 50-75% moderate, moderate and excessive impacted cerumen causing partial occlusion of the ear canal. Partial to very little of the tympanic membrane is visible.
- 75-100% severe, severe and excessive impacted cerumen causing partial or complete occlusion of the ear canal. Little if any of the tympanic membrane is visible.
Measured: Day0 and Day90
Hearing Function
Secondary aims: EFFICACY/PERFORMANCE PREVENTION for investigational device and for control group, in comparison to the baseline (Day0) using an audiogram (only for subjects more than 6).
Hearing function was assessed in patients on day 0 (D0) and day 90 (D90). The mean difference in hearing function (D90 - D0), expressed in decibels (dB), was reported in a data table. A mean difference greater than +5 dB is considered a gain in hearing function, while a mean difference less than -5 dB is considered a loss in hearing function. A difference in hearing function within the range [-5 dB; +5 dB] is considered to indicate no effect on hearing function.
Measured: Day0 and Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start6 Feb 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Excessive Ear WaxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iwona MAZUREWICZ, Principal investigator, Eurofins Dermscan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085443
- Sponsor's protocol ID
- 23E1670
- Status last verified
- Jun 2025
- First submitted
- 3 Oct 2023
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene
- ClinicalTrials.gov ID
- NCT06085443
- Acronym / sponsor ID
- 23E1670
- Conditions
- Excessive Ear Wax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular spray | Experimental | Other: Ear HygieneSubjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home. |
| Control | No intervention | –Subjects not using any spray (can use ear drops in case of discomfort or pain) |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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,..).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear Hygiene2 sprays in each ear, every 3 days at home | Other | Auricular spray |
Primary outcome
Skin Irritation
Time frame: Day0 and Day90
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).
2 secondary outcomes
Ear Canal Obstruction Due to Excessive Earwax
Time frame: Day0 and Day90
Hearing Function
Time frame: Day0 and Day90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iwona MAZUREWICZ principal investigator
Eurofins Dermscan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear Hygiene in people with Excessive Ear Wax, run by YSLab at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Irritation (time frame: Day0 and Day90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.