NCT06110117

Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose

Open Clinical Investigation to Evaluate Efficacy and Safety of the Medical Device "Sterimar Stop & Protect Irritation & Dryness" in Adults With Dry or Irritated Nose

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test symptom relief in subjects suffering from irritated or dry nasal passages. The main question it aims to answer is whether use of the nasal spray provides relief from dry nose symptoms. Participants will use the product for one week and report on the severity of their symptoms before and during use.

Detailed description

The aim of this clinical investigation is to evaluate the efficacy and safety of a product among subjects suffering from the irritated or dry nasal mucosa triggered by any causes. Sterimar Stop \& Protect Irritation \& Dryness, similar to other nasal saline solutions, can clean the nose and eliminates impurities, restores natural moisture, and helps prevent ear, nose, and throat (ENT) disorders, consequently improving the quality of life. The test product is a seawater-based nasal spray enriched with sodium thiosulfate pentahydrate and sodium hyaluronate and is currently marketed in France. The current study is to evaluate the clinical benefits associated with using Sterimar Stop \& Protect Irritation \& Dryness in the relief of nasal dryness and irritation symptoms triggered by any causes. 60 subjects will be included in this single arm open label study. Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day) for seven days.

Conditions

• Dry Nose

Interventions

Type	Name	Description
DEVICE	Sterimar Stop & Protect Irritation & Dryness	One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for seven days.

Timeline

• Start date: 2023-10-27
• Primary completion: 2024-03-15
• Completion: 2024-11-04
• First posted: 2023-10-31
• Last updated: 2024-11-20

Locations

2 sites across 1 country: Poland