Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray (NCT07204158) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray
65 participantsStarted 2025-10-07
Plain-language summary
The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.
Who can participate
Age range6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* IC1. Male, female over 6 years old.
* IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
* IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
* IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
* IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
* IC6. Signed informed consent (by patient and/or parent/legal guardian).
Exclusion Criteria:
* EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
* EC2. Patient with known hyper sensibility to the study treatment;
* EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
* EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the princip…
What they're measuring
1
Improvement of the nasal dryness symptoms
Timeframe: From enrollment to the end of treatment at 1 week