Nasal DrynessNCT07657247
Clinical Evaluation of the Efficacy of a Nasal Spray in the Treatment of Nasal Dryness
A study testing Spray pompe nasal in people with Nasal Dryness, run by YSLab.
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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to Mar 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gender: female and/or male.
- Age: adults and children from 6 years old:
- The physician's score for at least two symptoms, in addition to a dry nose, must average at least 2 at the enrolment visit (Day 0), for a minimum total score of 6.
- Subjects agree to refrain from taking any medication and/or taking any action to relieve nasal symptoms throughout the study, from Day -4 to Day 7, apart from acetaminophen.
- Autonomous adult, or minor with the consent of their legal representative.
- Subject and/or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
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- Subject and/or Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.
- Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use.
- Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.
Who cannot join
- Subjects taking anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), or topical or systemic decongestants within two weeks prior to Visit 1 and during the study.
- Subjects using other nasal sprays, nasal pumps, nasal irrigation/rinsing devices, or oils, creams, or gels in the nose within two weeks prior to Visit 1 and during the study.
- Subjects with a history of sensitivity to products related to the product being evaluated.
- Subjects with any clinically significant comorbid condition that, in the opinion of the principal investigator, could affect the subject's safety and/or participation in the study.
- Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
- Person refusing to sign the informed consent form prior to the study.
- Person participating or having participated in any other clinical study within the 30 days preceding the study.
- Person participating in any other clinical study.
About this study
Official title: Clinical Evaluation of the Efficacy of a Nasal Spray Based on Isotonic Seawater and Hyaluronic Acid in the Treatment of Nasal Dryness
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray pompe nasalDevice
Dosage: 2 sprays per nostril
| Study group | Role | What they receive |
|---|---|---|
| Nasal spray | Experimental | Not described Receives: Device: Spray pompe nasal |
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 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: Day 0 - Day 0 immediately after first use - Day 7
Secondary outcomes (2)
Improvement of the total perceive Nasal symptom relief
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: Day 0 - Day 0 immediately after first use - Day 7
Incidence of Adverse Events
Adverse events, if any, will be tabulated by the investigator
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Dec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657247
- Sponsor's protocol ID
- STUU526AA0790
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of a Nasal Spray Based on Isotonic Seawater and Hyaluronic Acid in the Treatment of Nasal Dryness
- ClinicalTrials.gov ID
- NCT07657247
- Acronym / sponsor ID
- STUU526AA0790
- Conditions
- Nasal Dryness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Jun 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 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 |
|---|---|---|
| Nasal spray | Experimental | Device: Spray pompe nasal |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Gender: female and/or male.
- Age: adults and children from 6 years old:
- The physician's score for at least two symptoms, in addition to a dry nose, must average at least 2 at the enrolment visit (Day 0), for a minimum total score of 6.
- Subjects agree to refrain from taking any medication and/or taking any action to relieve nasal symptoms throughout the study, from Day -4 to Day 7, apart from acetaminophen.
- Autonomous adult, or minor with the consent of their legal representative.
Key exclusion criteria (8 listed)
- Subjects taking anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), or topical or systemic decongestants within two weeks prior to Visit 1 and during the study.
- Subjects using other nasal sprays, nasal pumps, nasal irrigation/rinsing devices, or oils, creams, or gels in the nose within two weeks prior to Visit 1 and during the study.
- Subjects with a history of sensitivity to products related to the product being evaluated.
- Subjects with any clinically significant comorbid condition that, in the opinion of the principal investigator, could affect the subject's safety and/or participation in the study.
- Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
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 nasalDosage: 2 sprays per nostril | Device | Nasal spray |
Primary outcome
Improvement of the nasal dryness symptoms
Time frame: Day 0 - Day 0 immediately after first use - Day 7
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).
2 secondary outcomes
Improvement of the total perceive Nasal symptom relief
Time frame: Day 0 - Day 0 immediately after first use - Day 7
Incidence of Adverse Events
Time frame: through study completion, an average of 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 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spray pompe nasal in people with Nasal Dryness, run by YSLab.
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 9 inclusion and 8 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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: Day 0 - Day 0 immediately after first use - Day 7). 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 18 Jun 2026.