Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray
ConditionNasal Dryness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorYSLab
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 principal investigator, could interfere with the interpretation of study results;
Trial design
Treatments tested in this trial
- Spray pompe nasal confort
Treatment groups
65 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
YSLab
Lead sponsor
Eclevar Medtech
Collaborator
Source ClinicalTrials.gov