Cerumen ImpactionEARNCT07834593
Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
A study testing Unidose cerumenolytic solution and Spray cerumenolytic solution in people with Cerumen Impaction and Earwax Impaction, run by Laboratoires Gilbert at 3 sites in France.
Trial summary
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands and apocrine glands. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- What is being tested?
- Unidose cerumenolytic solution and Spray cerumenolytic solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Oct 2026to 22 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (including pregnant and breastfeeding women) or children aged 3 years and older, in accordance with the IFU;
- Presence of earwax excess or an earwax plug in the external ear canal (only one ear included even if both are affected), confirmed by a score ≥2 according to the obstruction scale and without damage to the eardrum.
- Subject willing and able to comply with the study requirements throughout the study period (and the parent for the child), including returning for a follow-up visit at the study site between Day 5 and Day 7.
- Subject having daily access to internet to complete the online questionnaires.
- Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself (or the parent for child).
- Subject who has been informed and has signed the informed consent form (or the parent for the child).
- Subject enrolled in a social security program (Art. L1121-8-1 of the CSP).
Who cannot join
- Contraindications specified in each device's instructions for use:
- In case of history of a damaged or perforated eardrum1,
- In case of otitis,
- subject with tympanostomy tubes (also called grommets) at the time of inclusion,
- In case of damaged skin of the ear canal.
- Known hypersensitivity or allergy to any of the investigational device's components.
Show all 17Show fewer
- History of ear infection (suppurative otitis media, otitis interna, mastoiditis) within the 2 months prior to enrollment, or an otitis externa within the 2 weeks prior to enrollment.
- Severe inner ear disorders or non-infectious ear conditions that may compromise participant safety, at the investigator's discretion.
- For the ear assessed in the study: Use within 5 days prior to inclusion of an ear solution containing solvents that act on earwax and may have a prolonged effect.
- For the ear assessed in the study: Use of A-CERUMEN® device (whatever the form) within 5 days prior to inclusion.
- Participation in another clinical trial or currently in the exclusion period of another clinical trial.
- Previous participation in this study.
- Presence of a condition or abnormality (social or psychological disorders, anticipated poor compliance, or inability to communicate) or use of a medication by the subject that, in the investigator's opinion, would compromise the subject's safety or the quality of the data; or that would prevent compliance with follow-up requirements.
- Vulnerable subject, with the exception of minors over 3 years of age and pregnant and breastfeeding women listed in inclusion criterion No. 1, pursuant to Articles 64, 66 of Regulation (EU) 2017/745 on medical devices and Articles L.1121-5, L.1121-6, L.1121-8 of the Public Health Code (France):
- Parturient women,
- Subject deprived of liberty, hospitalized without consent, or admitted to a health or social care facility for purposes other than research,
- Adults under protective supervision (guardianship, curatorship).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CHU Amiens Picardie
Amiens, 80054
Sandrine Soriot-Thomas, Dr, +33(0)3 22 08 79 97, Soriot-Thomas.Sandrine@chu-amiens.fr
Sandrine Soriot-Thomas, Dr
CHU de Brest - Hôpital Morvan
Brest, 29609
Rémi Marianowski, Pr, +33(0)2 98 22 35 51, remi.marianowski@chu-brest.fr
Rémi Marianowski, Pr
Hôpital Gabriel-Montpied
Clermont-Ferrand, 63000
Gisèle Pickering, Pr, +33(0)4 73 17 84 18, gisele.pickering@uca.fr
Elise Sortais, Dr
About this study
Official title: Post-Market Clinical Follow-Up to Assess the Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands and apocrine glands. Cerumen is part of the external ear defense mechanisms against foreign bodies and infectious agents, lubricating and cleaning the ear canal. Cerumen production is a normal and protective process for the ear canal. Cerumen is naturally removed through the renewal of the skin in the external auditory meatus, and through the chewing movements of the jaw. Nonetheless, earwax plug - defined as an accumulation of cerumen - is a frequent occurrence across all age groups, with notably higher rates in vulnerable populations. Causes of earwax plug comprise attempts to remove wax, as well as ear canal deformity. It also has been suggested that ear cleaning with cotton buds, particularly when the external ear canal is wet, might be one of the important causes of cerumen impaction. Earwax plug leads to hearing loss that is easily treatable but can have significant cognitive and social consequences. They can also delay the diagnosis of certain ear conditions, such as ear infections, which can lead to medical complications and have economic implications. Effective treatment options for earwax plug include cerumenolytic agents (water-based agents, oil-based agents, surfactant-based agents), irrigation with or without cerumenolytic pre-treatment, and manual removal. Inappropriate treatment options include cotton-tipped swabs, ear candling, olive oil drops or sprays, and non-chewing diets. A-CERUMEN® devices correspond to cerumenolytic agents' products composed of surfactant-based agents. Although all the available data points towards a good performance and safety profile of the devices under evaluation, the clinical data surrounding the devices under evaluation is based on only one or two studies and there is currently no data available on A-CERUMEN® devices for the pediatric patient population, or on pregnant and breastfeeding women. To address this gap, LABORATOIRES GILBERT plans in the Clinical Evaluation Report (CER) a confirmatory clinical trial to collect further data in the adult population and data in the pediatric population, pregnant and breastfeeding women for the devices under evaluation. The Instructions for Use (IFU) should be updated in accordance with the findings of this study. In this context, LABORATOIRES GILBERT promotes a Post-Market Clinical Follow-Up (PMCF) study to assess independently performance, safety and patient satisfaction of A-CERUMEN® Spray and A-CERUMEN® Unidose devices. This PMCF study must include pediatric population and pregnant/breastfeeding women.
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Being tested
- Unidose cerumenolytic solution, Spray cerumenolytic solution
- Keywords
- earwax, earwax plug, cerumen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unidose cerumenolytic solutionDevice
Also called A-CERUMEN® unidose
A-CERUMEN® unidose with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)
Spray cerumenolytic solutionDevice
Also called A-CERUMEN® spray
A-CERUMEN® spray with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)
| Study group | Role | What they receive |
|---|---|---|
| A-CERUMEN® unidose | Experimental | External ear cleaning solution in unidose container. Physiodose® will be used as rinsing solution after A-CERUMEN unidose application. Receives: Device: Unidose cerumenolytic solution |
| A-CERUMEN® spray | Experimental | External ear cleaning solution, auricular spray. Physiodose® will be used as rinsing solution after A-CERUMEN spray application. Receives: Device: Spray cerumenolytic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of earwax clearance using A-CERUMEN® Spray
The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
Measured: From enrollment to the end of treatment at 5-7 days
Extent of earwax clearance using A-CERUMEN® Unidose
The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
Measured: From enrollment to the end of treatment at 5-7days
Secondary outcomes (24)
Percentage of participants with complete earwax clearance using A-CERUMEN® Spray
Percentage of participants (or ears) achieving complete clearance of earwax, defined as an ear canal obstruction score of 0 after treatment, assessed by a blinded investigator based on photographs of the ear canal.
Measured: From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Spray
Percentage of participants (or ears) with a reduction of at least one grade in the ear canal obstruction score, assessed by a blinded investigator based on photographs of the ear canal.
Measured: From enrollment to the end of treatment at 5-7 days
Percentage of participants with complete earwax clearance using A-CERUMEN® Unidose
Percentage of participants (or ears) achieving complete clearance of earwax, defined as an ear canal obstruction score of 0 after treatment, assessed by a blinded investigator based on photographs of the ear canal.
Measured: From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Unidose
Percentage of participants (or ears) with a reduction of at least one grade in the ear canal obstruction score, assessed by a blinded investigator based on photographs of the ear canal.
Measured: From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Spray
Total number of adverse device events (ADEs) reported during the study period.
Measured: From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Spray
Total number of device deficiencies (DDs) reported during the study period.
Measured: From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Spray
Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
Measured: From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Unidose
Total number of adverse device events (ADEs) reported during the study period.
Measured: From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Unidose
Total number of device deficiencies (DDs) reported during the study period.
Measured: From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Unidose
Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
Measured: From enrollment to the end of treatment at 5-7 days
Daily change in earwax-related symptom intensity using A-CERUMEN® Spray
Daily change in the intensity of earwax-related symptoms (irritation, clogged sensation, ringing/tinnitus, hearing loss, itching, pain, tingling, swelling) in participants who were symptomatic at inclusion. Evaluated using an 11-point numeric rating scale ranging from 0 (absence of symptom) to 10 (very intense symptom). Higher scores indicate a worse outcome (greater symptom intensity).
Measured: Daily from enrollment to the end of treatment at 5-7days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Spray
Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
Measured: At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Spray
Percentage of participants requiring an additional medical or mechanical intervention to remove earwax after treatment with A-CERUMEN®.
Measured: At the end of treatment (5-7 days)
Daily change in earwax-related symptom intensity using A-CERUMEN® Unidose
Daily change in the intensity of earwax-related symptoms (irritation, clogged sensation, ringing/tinnitus, hearing loss, itching, pain, tingling, swelling) in participants who were symptomatic at inclusion. Evaluated using an 11-point numeric rating scale ranging from 0 (absence of symptom) to 10 (very intense symptom). Higher scores indicate a worse outcome (greater symptom intensity).
Measured: Daily from enrollment to the end of treatment at 5-7 days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Unidose
Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
Measured: At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Unidose
Percentage of participants requiring an additional medical or mechanical intervention to remove earwax after treatment with A-CERUMEN®.
Measured: At the end of treatment (5-7 days)
Overall participant satisfaction with A-CERUMEN® Spray
Overall participant (or parent) satisfaction regarding the treatment, assessed via the ePRO satisfaction questionnaire. Evaluated using an 11-point numeric rating scale ranging from 0 (not at all satisfied) to 10 (totally satisfied). Higher scores indicate a better outcome (greater satisfaction).
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Spray and flushing method
Participant (or parent) reported ease of handling, flushing effectiveness, and flushing practicality, assessed via the ePRO satisfaction questionnaire. Evaluated using 5-point Likert scales ranging from 1 (very difficult/poor) to 5 (very easy/good). Higher scores indicate a better outcome (greater ease/effectiveness/convenience).
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Spray
Percentage of participants (or parents) reporting they would reuse the product in case of earwax plugs, assessed via a binary question (yes/no) in the ePRO satisfaction questionnaire.
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Overall participant satisfaction with A-CERUMEN® Unidose
Overall participant (or parent) satisfaction regarding the treatment, assessed via the ePRO satisfaction questionnaire. Evaluated using an 11-point numeric rating scale ranging from 0 (not at all satisfied) to 10 (totally satisfied). Higher scores indicate a better outcome (greater satisfaction).
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Unidose and flushing method
Participant (or parent) reported ease of handling, flushing effectiveness, and flushing practicality, assessed via the ePRO satisfaction questionnaire. Evaluated using 5-point Likert scales ranging from 1 (very difficult/poor) to 5 (very easy/good). Higher scores indicate a better outcome (greater ease/effectiveness/convenience).
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Unidose
Percentage of participants (or parents) reporting they would reuse the product in case of earwax plugs, assessed via a binary question (yes/no) in the ePRO satisfaction questionnaire.
Measured: At the end of treatment or no later than Visit 2 (up to 7 days)
Adherence to A-CERUMEN® Spray treatment
Number of A-CERUMEN® Spray applications administered during the treatment period (recommended usage: 2 applications per day for 4 days; target total: 8 applications).
Measured: From enrollment to the end of treatment at 5-7 days
Adherence to A-CERUMEN® Unidose treatment
Number of A-CERUMEN® Single-dose applications administered during the treatment period (recommended usage: 2 applications per day for 4 days; target total: 8 applications).
Measured: From the enrollment to the end of treatment at 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion22 May 2027 (estimated)
- Study completion22 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerumen ImpactionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-comparative, 2 parallel groups, single-blind, prospective, multicenter clinical investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Gilbert
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Marc Henocq, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834593
- Sponsor's protocol ID
- 2026-A00953-48
- Acronym
- EAR
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing is planned.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up to Assess the Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
- ClinicalTrials.gov ID
- NCT07834593
- Acronym / sponsor ID
- EAR / 2026-A00953-48
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Keywords
- earwax, earwax plug, cerumen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Laboratoires GilbertIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands and apocrine glands. Cerumen is part of the external ear defense mechanisms against foreign bodies and infectious agents, lubricating and cleaning the ear canal. Cerumen production is a normal and protective process for the ear canal. Cerumen is naturally removed through the renewal of the skin in the external auditory meatus, and through the chewing movements of the jaw. Nonetheless, earwax plug - defined as an accumulation of cerumen - is a frequent occurrence across all age groups, with notably higher rates in vulnerable populations. Causes of earwax plug comprise attempts to remove wax, as well as ear canal deformity. It also has been suggested that ear cleaning with cotton buds, particularly when the external ear canal is wet, might be one of the important causes of cerumen impaction. Earwax plug leads to hearing loss that is easily treatable but can have significant cognitive and social consequences. They can also delay the diagnosis of certain ear conditions, such as ear infections, which can lead to medical complications and have economic implications. Effective treatment options for earwax plug include cerumenolytic agents (water-based agents, oil-based agents, surfactant-based agents), irrigation with or without cerumenolytic pre-treatment, and manual removal. Inappropriate treatment options include cotton-tipped swabs, ear candling, olive oil drops or sprays, and non-chewing diets. A-CERUMEN® devices correspond to cerumenolytic agents' products composed of surfactant-based agents. Although all the available data points towards a good performance and safety profile of the devices under evaluation, the clinical data surrounding the devices under evaluation is based on only one or two studies and there is currently no data available on A-CERUMEN® devices for the pediatric patient population, or on pregnant and breastfeeding women. To address this gap, LABORATOIRES GILBERT plans in the Clinical Evaluation Report (CER) a confirmatory clinical trial to collect further data in the adult population and data in the pediatric population, pregnant and breastfeeding women for the devices under evaluation. The Instructions for Use (IFU) should be updated in accordance with the findings of this study. In this context, LABORATOIRES GILBERT promotes a Post-Market Clinical Follow-Up (PMCF) study to assess independently performance, safety and patient satisfaction of A-CERUMEN® Spray and A-CERUMEN® Unidose devices. This PMCF study must include pediatric population and pregnant/breastfeeding women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, non-comparative, 2 parallel groups, single-blind, prospective, multicenter clinical investigation
| Arm | Type | Receives |
|---|---|---|
| A-CERUMEN® unidose | Experimental | Device: Unidose cerumenolytic solutionExternal ear cleaning solution in unidose container. Physiodose® will be used as rinsing solution after A-CERUMEN unidose application. |
| A-CERUMEN® spray | Experimental | Device: Spray cerumenolytic solutionExternal ear cleaning solution, auricular spray. Physiodose® will be used as rinsing solution after A-CERUMEN spray application. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (including pregnant and breastfeeding women) or children aged 3 years and older, in accordance with the IFU;
- Presence of earwax excess or an earwax plug in the external ear canal (only one ear included even if both are affected), confirmed by a score ≥2 according to the obstruction scale and without damage to the eardrum.
- Subject willing and able to comply with the study requirements throughout the study period (and the parent for the child), including returning for a follow-up visit at the study site between Day 5 and Day 7.
- Subject having daily access to internet to complete the online questionnaires.
- Subject able to understand verbal and written local language and in capacity to fill-in questionnaire by himself (or the parent for child).
Key exclusion criteria (17 listed)
- Contraindications specified in each device's instructions for use:
- Known hypersensitivity or allergy to any of the investigational device's components.
- History of ear infection (suppurative otitis media, otitis interna, mastoiditis) within the 2 months prior to enrollment, or an otitis externa within the 2 weeks prior to enrollment.
- Severe inner ear disorders or non-infectious ear conditions that may compromise participant safety, at the investigator's discretion.
- For the ear assessed in the study: Use within 5 days prior to inclusion of an ear solution containing solvents that act on earwax and may have a prolonged effect.
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 |
|---|---|---|
| Unidose cerumenolytic solutionAlso: A-CERUMEN® unidoseA-CERUMEN® unidose with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications) | Device | A-CERUMEN® unidose |
| Spray cerumenolytic solutionAlso: A-CERUMEN® sprayA-CERUMEN® spray with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications) | Device | A-CERUMEN® spray |
Primary outcome
Extent of earwax clearance using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7 days
The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
Extent of earwax clearance using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7days
The primary outcome is the change in ear canal obstruction score measured before and after treatment, assessed by a blinded investigator using photographs of the ear canal. Ear canal obstruction is evaluated using a 5-point ear canal obstruction scale ranging from 0 (no obstruction, 0-2% of eardrum obscured) to 4 (severe obstruction, 76-100% of eardrum obscured). Higher scores indicate a worse outcome (greater obstruction).
24 secondary outcomes
Percentage of participants with complete earwax clearance using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7 days
Percentage of participants with complete earwax clearance using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7days
Percentage of participants with at least one grade reduction in obstruction score using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Spray
Time frame: From enrollment to the end of treatment at 5-7 days
Number of adverse device events using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7days
Number of device deficiencies using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7 days
Percentage of participants with at least one adverse device event using A-CERUMEN® Unidose
Time frame: From enrollment to the end of treatment at 5-7 days
Daily change in earwax-related symptom intensity using A-CERUMEN® Spray
Time frame: Daily from enrollment to the end of treatment at 5-7days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Spray
Time frame: At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Spray
Time frame: At the end of treatment (5-7 days)
Daily change in earwax-related symptom intensity using A-CERUMEN® Unidose
Time frame: Daily from enrollment to the end of treatment at 5-7 days
Percentage of participants with earwax symptom relief after using A-CERUMEN® Unidose
Time frame: At the end of treatment (5-7 days)
Percentage of participants requiring further intervention for earwax removal after using A-CERUMEN® Unidose
Time frame: At the end of treatment (5-7 days)
Overall participant satisfaction with A-CERUMEN® Spray
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Spray and flushing method
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Spray
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Overall participant satisfaction with A-CERUMEN® Unidose
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Ease of use and handling of A-CERUMEN® Unidose and flushing method
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Percentage of participants willing to reuse A-CERUMEN® Unidose
Time frame: At the end of treatment or no later than Visit 2 (up to 7 days)
Adherence to A-CERUMEN® Spray treatment
Time frame: From enrollment to the end of treatment at 5-7 days
Adherence to A-CERUMEN® Unidose treatment
Time frame: From the enrollment to the end of treatment at 5-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing is planned.
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.
Marc Henocq, Dr principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unidose cerumenolytic solution and Spray cerumenolytic solution in people with Cerumen Impaction and Earwax Impaction, run by Laboratoires Gilbert at 3 sites in France.
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 17 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ophélie FLAGEUL (+33(0)223061113, o.flageul@slbpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of earwax clearance using A-CERUMEN® Spray (time frame: From enrollment to the end of treatment at 5-7 days). The study lists 2 primary outcomes in all. 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 25 Sep 2026.