Dry NoseNCT07273318
Osmonar® Nasal Gel Versus Saline Solution in Patients With Dry Nose
A study testing Osmonar in people with Dry Nose, run by Michele Grasso at 1 site in Italy.
Trial summary
This study is being done to understand how well a medical device called OSMONAR Nasal Gel works and how safe it is for people who suffer from a dry nose. A dry nose can cause discomfort, crusting, irritation, and breathing difficulties. There are not many effective treatments available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Nose
- What is being tested?
- Osmonar
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2021to 19 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Patients affected by dry nose;
- Willing to comply with study requirements, using the tested products for 14 consecutive days;
- Readiness not to participate in another clinical study during this study;
- Commitment to using contraceptive methods (for women of childbearing age only);
- Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline (only for women in childbearing age);
- Written informed consent by the participant.
Who cannot join
- 1. Known allergy or hypersensitivity to the components of the OSMONAR or of saline solution; 4. Lesions/infections in the nasal area;
- 5. Use of preparations that may influence the study outcome within the last 2 weeks prior to baseline and during the study (e.g. antibiotics, corticosteroids etc.);
- 6. History or presence of any other clinically significant known (self-reported) condition /disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject;
- 7. Pregnancy, nursing or within first 3 months post-partum;
- 8. History of or current abuse of drugs, alcohol or medication;
- 9. Participation in another study during the last 30 days prior to baseline.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Otolaryngology - Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II
Lamezia Terme, CZ, 88046
About this study
Official title: Randomized, Open-Label, Comparative, Non-Profit Study to Evaluate the Performance and Safety of Osmonar® Medical Device Nasal Gel Versus Saline Solution in Patients With Dry Nose
This study is being done to understand how well a medical device called OSMONAR Nasal Gel works and how safe it is for people who suffer from a dry nose.
A dry nose can cause discomfort, crusting, irritation, and breathing difficulties. There are not many effective treatments available. This study may help doctors find a new and safe option for people with this condition.
Read more
About 60 adults with symptoms of dry nose will take part.
- 30 people will use OSMONAR Nasal Gel
- 30 people will use a saline solution (a simple salt-water solution) Both groups will have similar symptoms. This helps doctors compare the two products fairly.
Each participant will use the assigned product for 14 days applying it twice a day as follows:
- once in each nostril in the morning
- once in each nostril in the evening
Each participant will have three visits:
- Visit 1 - Start of the study
- Visit 2 - Day 7
- Day 14 (End of treatment)
At each visit, the study doctor will:
- Perform a general medical check-up;
- Confirm the diagnosis of dry nose;
- Ask the participant to rate how dry their nose feels using a 10-cm Visual Analog Scale (VAS);
- Examine the inside of the nose using a fiber-optic rhinoscope to check for crusts, blockage, or breathing problems;
- Ask about satisfaction with the product and how easy it was to use;
- Check the participant's safety and whether the product is well tolerated.
The study will look at:
- How well symptoms improve.
- Changes in nasal dryness and discomfort.
- How the inside of the nose looks during examination.
- How safe and well tolerated the treatment is.
- How satisfied participants are with the treatment.
This study was planned, organized, and performed autonomously as a non-profit study without any external support by the principal investigator of the Otorhinolaryngology Department at Giovanni Paolo II Hospital in Lamezia Terme.
The results of the study will help doctors learn whether OSMONAR Nasal Gel can be a safe and effective treatment for people with dry nose and whether it works better than saline solution:
Read the detailed description
Nasal dryness is a frequent condition caused by mucosal atrophy, chronic irritation, infections, environmental factors, or systemic diseases such as Sjögren's syndrome. Symptoms may include crusting, nasal obstruction, irritation, and breathing discomfort. Management typically involves eliminating triggering factors, maintaining hydration, humidifying the environment, and using topical agents such as saline solutions, oils, or hyaluronic-acid-based products.
This study evaluates the performance and safety of OSMONAR Nasal Gel, a medical device containing pyrohyaluronate (PCA) and hyaluronic acid (HA). The product is designed to hydrate the nasal mucosa, form a protective film against external irritants, and support mucosal repair. The aim is to determine whether OSMONAR can improve symptoms associated with dry nose more effectively than saline solution.
A total of 60 adults with dry nose syndrome will be randomized into two groups:
- OSMONAR Nasal Gel: one application per nostril twice daily for 14 days;
- Placebo (Isotonic saline solution): 1 application per nostril twice daily for 14 days.
The study is randomized and single-blind and includes three visits: baseline (Day 0), interim (Day 7), and final evaluation (Day 14). At each visit, participants will rate nasal dryness using a 10-cm Visual Analog Scale (VAS). In addition, nasal crusting, obstruction, and respiratory discomfort will be assessed by Investigator using fiber-optic rhinoscopy. Safety will be evaluated by monitoring adverse events.
- Conditions
- Dry Nose
- Being tested
- Osmonar, Placebo
- Keywords
- dry nose, medical device, randomized study, single-blind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsmonarDevice
one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days
PlaceboOther
one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| OSMONAR Nasal Gel | Experimental | Medical Device Class IIa Receives: Device: Osmonar |
| Isotonic saline solution | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective nasal dryness
The change in subjective nasal dryness, as evaluated by the patient using a Visual Analogue Scale (VAS) score ranging from 0 (no nasal dryness) to 10 (maximum level of nasal dryness), will be assessed from baseline to final visit (day 14). The mean values will be compared between the two treatment groups
Measured: 14 days
Incidence of adverse events
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) will be collected by Investigators, compared between the two groups, and analyzed with the incidence in standard population
Measured: 14 days
Secondary outcomes (3)
Presence of nasal crusts
Percentage of subjects with nasal crusts evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups
Measured: 14 days
Presence of nasal obstruction
Percentage of subjects with nasal obstruction evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups
Measured: 14 days
Presence of respiratory discomfort
Percentage of subjects with respiratory discomfort evaluated by fiber-optic rhinoscopy at baseline and at Final Visit (day 14). The decrease in % will be compared between the two treatment groups
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start9 Sep 2021
- Primary completion20 Oct 2021
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry NoseStudies 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 single-blind design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele Grasso
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor-investigator, Michele Grasso, GIOVANNI PAOLO II Hospital of Lamezia Terme
- Investigators
- Michele Grasso, Dr., Principal investigator, Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273318
- Sponsor's protocol ID
- DMS/21/OSMONAR/01
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Comparative, Non-Profit Study to Evaluate the Performance and Safety of Osmonar® Medical Device Nasal Gel Versus Saline Solution in Patients With Dry Nose
- ClinicalTrials.gov ID
- NCT07273318
- Acronym / sponsor ID
- DMS/21/OSMONAR/01
- Conditions
- Dry Nose
- Keywords
- dry nose, medical device, randomized study, single-blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Michele GrassoUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 9 Dec 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.
This study is being done to understand how well a medical device called OSMONAR Nasal Gel works and how safe it is for people who suffer from a dry nose.
A dry nose can cause discomfort, crusting, irritation, and breathing difficulties. There are not many effective treatments available. This study may help doctors find a new and safe option for people with this condition.
About 60 adults with symptoms of dry nose will take part.
- 30 people will use OSMONAR Nasal Gel
- 30 people will use a saline solution (a simple salt-water solution) Both groups will have similar symptoms. This helps doctors compare the two products fairly.
Each participant will use the assigned product for 14 days applying it twice a day as follows:
- once in each nostril in the morning
- once in each nostril in the evening
Each participant will have three visits:
- Visit 1 - Start of the study
- Visit 2 - Day 7
- Day 14 (End of treatment)
At each visit, the study doctor will:
- Perform a general medical check-up;
- Confirm the diagnosis of dry nose;
- Ask the participant to rate how dry their nose feels using a 10-cm Visual Analog Scale (VAS);
- Examine the inside of the nose using a fiber-optic rhinoscope to check for crusts, blockage, or breathing problems;
- Ask about satisfaction with the product and how easy it was to use;
- Check the participant's safety and whether the product is well tolerated.
The study will look at:
- How well symptoms improve.
- Changes in nasal dryness and discomfort.
- How the inside of the nose looks during examination.
- How safe and well tolerated the treatment is.
- How satisfied participants are with the treatment.
This study was planned, organized, and performed autonomously as a non-profit study without any external support by the principal investigator of the Otorhinolaryngology Department at Giovanni Paolo II Hospital in Lamezia Terme.
The results of the study will help doctors learn whether OSMONAR Nasal Gel can be a safe and effective treatment for people with dry nose and whether it works better than saline solution:
Detailed description
Nasal dryness is a frequent condition caused by mucosal atrophy, chronic irritation, infections, environmental factors, or systemic diseases such as Sjögren's syndrome. Symptoms may include crusting, nasal obstruction, irritation, and breathing discomfort. Management typically involves eliminating triggering factors, maintaining hydration, humidifying the environment, and using topical agents such as saline solutions, oils, or hyaluronic-acid-based products.
This study evaluates the performance and safety of OSMONAR Nasal Gel, a medical device containing pyrohyaluronate (PCA) and hyaluronic acid (HA). The product is designed to hydrate the nasal mucosa, form a protective film against external irritants, and support mucosal repair. The aim is to determine whether OSMONAR can improve symptoms associated with dry nose more effectively than saline solution.
A total of 60 adults with dry nose syndrome will be randomized into two groups:
- OSMONAR Nasal Gel: one application per nostril twice daily for 14 days;
- Placebo (Isotonic saline solution): 1 application per nostril twice daily for 14 days.
The study is randomized and single-blind and includes three visits: baseline (Day 0), interim (Day 7), and final evaluation (Day 14). At each visit, participants will rate nasal dryness using a 10-cm Visual Analog Scale (VAS). In addition, nasal crusting, obstruction, and respiratory discomfort will be assessed by Investigator using fiber-optic rhinoscopy. Safety will be evaluated by monitoring adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized single-blind design
| Arm | Type | Receives |
|---|---|---|
| OSMONAR Nasal Gel | Experimental | Device: OsmonarMedical Device Class IIa |
| Isotonic saline solution | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old;
- Patients affected by dry nose;
- Willing to comply with study requirements, using the tested products for 14 consecutive days;
- Readiness not to participate in another clinical study during this study;
- Commitment to using contraceptive methods (for women of childbearing age only);
Key exclusion criteria (6 listed)
- 1. Known allergy or hypersensitivity to the components of the OSMONAR or of saline solution; 4. Lesions/infections in the nasal area;
- 5. Use of preparations that may influence the study outcome within the last 2 weeks prior to baseline and during the study (e.g. antibiotics, corticosteroids etc.);
- 6. History or presence of any other clinically significant known (self-reported) condition /disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject;
- 7. Pregnancy, nursing or within first 3 months post-partum;
- 8. History of or current abuse of drugs, alcohol or medication;
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 |
|---|---|---|
| Osmonarone application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days | Device | OSMONAR Nasal Gel |
| Placeboone application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days | Other | Isotonic saline solution |
Primary outcome
Subjective nasal dryness
Time frame: 14 days
The change in subjective nasal dryness, as evaluated by the patient using a Visual Analogue Scale (VAS) score ranging from 0 (no nasal dryness) to 10 (maximum level of nasal dryness), will be assessed from baseline to final visit (day 14). The mean values will be compared between the two treatment groups
Incidence of adverse events
Time frame: 14 days
The incidence of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) will be collected by Investigators, compared between the two groups, and analyzed with the incidence in standard population
3 secondary outcomes
Presence of nasal crusts
Time frame: 14 days
Presence of nasal obstruction
Time frame: 14 days
Presence of respiratory discomfort
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) that underlie results in a publication
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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.
Michele Grasso, Dr. principal investigator
Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osmonar in people with Dry Nose, run by Michele Grasso at 1 site in Italy.
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 6 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 18 Dec 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 Italy. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective nasal dryness (time frame: 14 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 18 Dec 2025.