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

NCT07273318 | Completed

• 1 other identifier: DMS/21/OSMONAR/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

Conditions

Dry Nose

Keywords

dry nose; medical device; randomized study; single-blind

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days

Secondary Outcomes (3)

• Presence of nasal crusts

  14 days

• Presence of nasal obstruction

  14 days

• Presence of respiratory discomfort

  14 days

Study Arms (2)

OSMONAR Nasal Gel

EXPERIMENTAL

Medical Device Class IIa

Device: Osmonar

Isotonic saline solution

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Osmonar DEVICE

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

OSMONAR Nasal Gel

Placebo OTHER

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

Isotonic saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Known allergy or hypersensitivity to the components of the OSMONAR or of saline solution; 4. Lesions/infections in the nasal area;
• \. 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.);
• \. 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;
• \. Pregnancy, nursing or within first 3 months post-partum;
• \. History of or current abuse of drugs, alcohol or medication;
• \. Participation in another study during the last 30 days prior to baseline.

Sponsors & Collaborators

• Michele Grasso: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Department of Otolaryngology - Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

Lamezia Terme, CZ, 88046, Italy

Location

Study Officials

• Michele Grasso, Dr.

  Presidio Ospedaliero di Lamezia Terme Giovanni Paolo II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized single-blind design

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: September 9, 2021
• Primary Completion: October 20, 2021
• Study Completion: December 19, 2022
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: IPD will be available from the corresponding author, upon reasonable request after the result publication.
• Access Criteria: Other researchers will receive the IPD upon reasonable request from the corresponding author.

Locations

IT (1)