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

NCT06110117 | Completed

• 1 other identifier: ST-22-U62
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dry Nose

Outcome Measures

Primary Outcomes (1)

• Change in patient-reported total irritation score from baseline

  Sum of scores of 12 symptoms: nasal dryness, nasal crusting, nasal bleeding, nasal itching, nasal burning, nasal obstruction, nasal pain, nasal discomfort, sneezing, reduced sense of smell, external nasal redness, and external nasal swelling. Total score ranges from 0 to 36 in 0.5 unit increments with higher scores indicating more severe symptoms. (Lower is better)

  One week of product use.

Secondary Outcomes (8)

• Change in patient-reported symptom score from baseline for each of the 12 symptoms from baseline to day 7.

  One week of product use.

• Change in patient-reported quality of life question from baseline to day 7.

  One week of product use.

• Day on which a state of well-being of nose was achieved.

  One week of product use.

• Change from baseline in morning/evening total irritation and individual symptom scores.

  One week of product use.

• Immediate relief for individual symptom scores after first product application of the day.

  1 minute, 10 minutes, and 1 hour after first application on day 0 and on day 6.

Study Arms (1)

Nasal Spray

EXPERIMENTAL

1 to 2 sprays per nostril of Sterimar Stop \& Protect Irritation \& Dryness 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.

Device: Sterimar Stop & Protect Irritation & Dryness

Interventions

Sterimar Stop & Protect Irritation & Dryness DEVICE

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.

Nasal Spray

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥18 years of age;
• Subjects must have ongoing nasal irritation or dryness at Visit 1 (Day -4);
• Total Irritation Score (sum of all 12 symptom scores) must average at least 8 over the three-day run-in period (Day -3 to -1) and must be at least 8 at Visit 2 (Day 0). (Individual symptom score range is 0 - 3; Total Irritation Score range is 0 - 36.)
• Dry Nose Symptom Score must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Dry nose symptom score range is 0 - 3.)
• The score of at least two other symptoms beside dry nose must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Each symptom score range is 0 - 3.)
• Twenty-five percent of the included subjects must have ongoing nasal symptoms caused by indoor pollutants from fireplaces, candles, smoking, or cooking, verified by principal investigator;
• Subjects are willing to refrain from using any medications and/or acts for relief of nasal symptoms during the whole study from Day -4 to Day 7; except for acetaminophen, ibuprofen, or vitamins;
• Subjects are willing and able to comply with the requirements of the study to use the study product according to use instructions, complete the daily symptom and product diaries and questionnaire(s), and visit the test facility as instructed;
• Subjects can read, understand, and sign an informed consent document after being advised of the nature of the study.

You may not qualify if:

• Currently taking any over-the-counter and prescription systemic/topical corticosteroids, antibiotics, antihistamines, cromone, nonsteroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists or topical or systemic decongestants within the two weeks prior to Visit 1;
• Currently using other nasal sprays, nasal pumps, nasal irrigation/lavage devices, or oils, creams, or gels into the nose;
• Women who are pregnant and/or breastfeeding or planning to become pregnant during the study and within 30 days after the last application of the study product;
• Have a dermatologic, respiratory, or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.) which, in the opinion of the principal investigator, could interfere with the interpretation of study results at the time of the screening visit (Day -4);
• Have a positive medical history of any significant illness within the 2 weeks prior to the screening visit (Day -4), which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• Have a known allergy to any food or personal care products;
• Have any kind of immunodeficiency;
• Have a history of sensitivity to products as related to the product being evaluated;
• Positive Coronavirus disease (COVID-19) test during the month before the study or during the study;
• Self-reported history of anaphylaxis;
• Confirmed diagnosis of urticaria or eczema;
• Confirmed diagnosis of asthma that requires more than intermittent rescue beta-agonist treatment, for example, before exercise;
• Immunotherapy during the past two years or ongoing immunotherapy;
• Recent nasal or sinus surgery within the last six months;
• Use of other nasal spray, pump, continuous positive airway pressure machine, nasal irrigation/lavage device, internal nasal gel, or nasal oil within 2 weeks before the screening visit (Day -4);

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (2)

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

Location

Centrum medyczne

Sztum, 80-400, Poland

Location

MeSH Terms

Interventions

Desiccation

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be evaluated for symptom severity before and during use of the nasal spray product.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: October 27, 2023
• Primary Completion: March 15, 2024
• Study Completion: November 4, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)