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Osmonar® Nasal Gel Versus Saline Solution in Patients With Dry Nose

NCT07273318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-18

No results posted yet for this study

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:

Conditions

  • Dry Nose

Interventions

DEVICE

Osmonar

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

OTHER

Placebo

one application per nostril twice daily (in the morning and in the evening) administered for 14 consecutive days

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Michele Grasso

    lead OTHER

Principal Investigators

  • Michele Grasso, Dr. · Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2021-10-20
Completion
2022-12-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273318 on ClinicalTrials.gov