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

Last updated: November 18, 2024
Sponsor: Church & Dwight Company, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Sterimar Stop & Protect Irritation & Dryness

Clinical Study ID

NCT06110117
ST-22-U62
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female subjects ≥18 years of age;

  2. Subjects must have ongoing nasal irritation or dryness at Visit 1 (Day -4);

  3. Total Irritation Score (sum of all 12 symptom scores) must average at least 8 overthe 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.)

  4. Dry Nose Symptom Score must average at least 2 over the three-day run-in period andmust be at least 2 at Visit 2 (Day 0). (Dry nose symptom score range is 0 - 3.)

  5. The score of at least two other symptoms beside dry nose must average at least 2over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Eachsymptom score range is 0 - 3.)

  6. Twenty-five percent of the included subjects must have ongoing nasal symptoms causedby indoor pollutants from fireplaces, candles, smoking, or cooking, verified byprincipal investigator;

  7. Subjects are willing to refrain from using any medications and/or acts for relief ofnasal symptoms during the whole study from Day -4 to Day 7; except foracetaminophen, ibuprofen, or vitamins;

  8. Subjects are willing and able to comply with the requirements of the study to usethe study product according to use instructions, complete the daily symptom andproduct diaries and questionnaire(s), and visit the test facility as instructed;

  9. Subjects can read, understand, and sign an informed consent document after beingadvised of the nature of the study.

Exclusion

Exclusion Criteria:

  1. Currently taking any over-the-counter and prescription systemic/topicalcorticosteroids, antibiotics, antihistamines, cromone, nonsteroidalanti-inflammatory drugs (NSAIDs), leukotriene antagonists or topical or systemicdecongestants within the two weeks prior to Visit 1;

  2. Currently using other nasal sprays, nasal pumps, nasal irrigation/lavage devices, oroils, creams, or gels into the nose;

  3. Women who are pregnant and/or breastfeeding or planning to become pregnant duringthe study and within 30 days after the last application of the study product;

  4. Have a dermatologic, respiratory, or medical condition (e.g., asthma, pneumonia,laryngotracheobronchitis, sinusitis, etc.) which, in the opinion of the principalinvestigator, could interfere with the interpretation of study results at the timeof the screening visit (Day -4);

  5. Have a positive medical history of any significant illness within the 2 weeks priorto the screening visit (Day -4), which, in the opinion of the principalinvestigator, could interfere with the interpretation of study results;

  6. Have a known allergy to any food or personal care products;

  7. Have any kind of immunodeficiency;

  8. Have a history of sensitivity to products as related to the product being evaluated;

  9. Positive Coronavirus disease (COVID-19) test during the month before the study orduring the study;

  10. Self-reported history of anaphylaxis;

  11. Confirmed diagnosis of urticaria or eczema;

  12. Confirmed diagnosis of asthma that requires more than intermittent rescuebeta-agonist treatment, for example, before exercise;

  13. Immunotherapy during the past two years or ongoing immunotherapy;

  14. Recent nasal or sinus surgery within the last six months;

  15. Use of other nasal spray, pump, continuous positive airway pressure machine, nasalirrigation/lavage device, internal nasal gel, or nasal oil within 2 weeks before thescreening visit (Day -4);

  16. Presence of nasal polyposis and chronic sinusitis (assessed by the PI);

  17. Nasal anatomic abnormality, e.g., severely deviated septum, congenital cleftlip/palate, nasal bleeding diathesis (assessed by the PI); and/or

  18. Any clinically significant co-morbid condition, which, in PI's opinion, may affectthe subject's safety and/or participation in the study.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Sterimar Stop & Protect Irritation & Dryness
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
November 04, 2024

Study 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.

Connect with a study center

  • Eurofins Dermscan Poland

    Gdańsk, 80-288
    Poland

    Site Not Available

  • Centrum medyczne

    Sztum, 80-400
    Poland

    Site Not Available

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