Status:
COMPLETED
Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose
Lead Sponsor:
Church & Dwight Company, Inc.
Conditions:
Dry Nose
Eligibility:
All Genders
18-100 years
Phase:
NA
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 rel...
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 \& Pro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- Presence of nasal polyposis and chronic sinusitis (assessed by the PI);
- Nasal anatomic abnormality, e.g., severely deviated septum, congenital cleft lip/palate, nasal bleeding diathesis (assessed by the PI); and/or
- Any clinically significant co-morbid condition, which, in PI's opinion, may affect the subject's safety and/or participation in the study.
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06110117
Start Date
October 27 2023
End Date
November 4 2024
Last Update
November 20 2024
Active Locations (2)
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1
Eurofins Dermscan Poland
Gdansk, Poland, 80-288
2
Centrum medyczne
Sztum, Poland, 80-400