An interventional study of Unidose cerumenolytic solution and Spray cerumenolytic solution in Cerumen Impaction, Earwax Impaction and Earwax Plug, sponsored by Laboratoires Gilbert. Not yet recruiting at 3 sites in France. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Laboratoires Gilbert · Not applicable, Interventional, and Treatment
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.
Laboratoires Gilbert is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
specified in each device's instructions for use:
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
External ear cleaning solution in unidose container. Physiodose® will be used as rinsing solution after A-CERUMEN unidose application.
Device: Unidose cerumenolytic solution
External ear cleaning solution, auricular spray. Physiodose® will be used as rinsing solution after A-CERUMEN spray application.
Device: Spray cerumenolytic solution
A-CERUMEN® unidose with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)
Also known as: A-CERUMEN® unidose
A-CERUMEN® spray with Physiodose® (as rinsing agent) for earwax excess removal during 4 days (8 applications)
Also known as: A-CERUMEN® spray
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).
Time frame: 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).
Time frame: From enrollment to the end of treatment at 5-7days
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
Time frame: 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.
Time frame: 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.
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
Percentage of participants who experienced at least one adverse device event (ADE) during the study period.
Time frame: 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).
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
Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
Time frame: 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®.
Time frame: 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).
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
Percentage of participants reporting relief of earwax-related symptoms at the end of treatment.
Time frame: 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®.
Time frame: 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).
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
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).
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
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.
Time frame: 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).
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
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).
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
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.
Time frame: 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).
Time frame: 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).
Time frame: From the enrollment to the end of treatment at 5-7 days
Plan to share: No — No individual participant data sharing is planned.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Laboratoires Gilbert