Nasal DrynessNCT07204158
Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray
A study testing Spray pompe nasal confort in people with Nasal Dryness, run by YSLab at 1 site in France.
Trial summary
The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Nasal Dryness
- What is being tested?
- Spray pompe nasal confort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IC1. Male, female over 6 years old.
- IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
- IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
- IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
- IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
- IC6. Signed informed consent (by patient and/or parent/legal guardian).
Who cannot join
- EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
- EC2. Patient with known hyper sensibility to the study treatment;
- EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
- EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
- EC5. Patients with a positive medical history of any significant illness in the 2 weeks preceding the study, which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
- EC6. Patients with nasal anatomical anomalies, e.g., severely deviated septum, congenital cleft lip/palate, nasal hemorrhagic diathesis (assessed by principal investigator);
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- EC7. Patient that uses cocaine or other inhaled drugs
- EC8. Patients with any clinically significant co-morbid condition that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
- EC9. Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial;
- EC10. Women of childbearing age (except menopausal, hysterectomized, and sterilized) are not using effective contraception (oral contraceptives, intra-uterine devices, contraceptive implants, or condoms);
- EC11. A person belonging to a population referred to in articles 64 (incapacitated subjects), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in an emergency) of the MDR 2017/745.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray in Children and Adults With Nasal Dryness: a Prospective, Multicentric, Non-randomized Study in Real-life Conditions.
The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.
- Conditions
- Nasal Dryness
- Being tested
- Spray pompe nasal confort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray pompe nasal confortDevice
Seawater solution with hyaluronan
| Study group | Role | What they receive |
|---|---|---|
| subject using the device | Experimental | Not described Receives: Device: Spray pompe nasal confort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the nasal dryness symptoms
The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).
Measured: From enrollment to the end of treatment at 1 week
Secondary outcomes (2)
Improvement of the total perceive Nasal symptom relief
The changes between the baseline and day 7 will be assessed using the Rhinitis Sicca Symptom Score (RSSS). The RSSS is constituted by the sum of the following individual symptoms: sensation of dry nose, impairment of nasal breathing/nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, anterior nasal discharge /runny nose, thick nasal discharge, desire to clear one's throat/ dry throat, impairment of smell and impairment of sleep. Patients assessed with each of these symptoms on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).
Measured: From enrollment to the end of treatment at 1 week
Safety endpoint
Adverse events, if any, will be tabulated by the investigator
Measured: From enrollment to the end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Why it stopped: The study was closed prematurely due to administrative issues unrelated to participant safety or study outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DrynessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204158
- Sponsor's protocol ID
- 2025-A00666-43
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray in Children and Adults With Nasal Dryness: a Prospective, Multicentric, Non-randomized Study in Real-life Conditions.
- ClinicalTrials.gov ID
- NCT07204158
- Acronym / sponsor ID
- 2025-A00666-43
- Conditions
- Nasal Dryness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was closed prematurely due to administrative issues unrelated to participant safety or study outcomes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 2 Oct 2025 (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 purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subject using the device | Experimental | Device: Spray pompe nasal confort |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- IC1. Male, female over 6 years old.
- IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
- IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
- IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
- IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
Key exclusion criteria (11 listed)
- EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
- EC2. Patient with known hyper sensibility to the study treatment;
- EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
- EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
- EC5. Patients with a positive medical history of any significant illness in the 2 weeks preceding the study, which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
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 |
|---|---|---|
| Spray pompe nasal confortSeawater solution with hyaluronan | Device | subject using the device |
Primary outcome
Improvement of the nasal dryness symptoms
Time frame: From enrollment to the end of treatment at 1 week
The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).
2 secondary outcomes
Improvement of the total perceive Nasal symptom relief
Time frame: From enrollment to the end of treatment at 1 week
Safety endpoint
Time frame: From enrollment to the end of treatment at 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spray pompe nasal confort in people with Nasal Dryness, run by YSLab at 1 site 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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 27 Aug 2026. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement of the nasal dryness symptoms (time frame: From enrollment to the end of treatment at 1 week). 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 27 Aug 2026.