Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07273318
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osmonar® Nasal Gel Versus Saline Solution in Patients With Dry Nose
Sponsor:
Michele Grasso
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: