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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Spray pompe nasal confort
DeviceSeawater solution with hyaluronan
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: subject using the deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of the nasal dryness symptoms
The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).
Time frame
From enrollment to the end of treatment at 1 weekSecondary outcomes
1
Improvement of the total perceive Nasal symptom relief
The changes between the baseline and day 7 will be assessed using the Rhinitis Sicca Symptom Score (RSSS). The RSSS is constituted by the sum of the following individual symptoms: sensation of dry nose, impairment of nasal breathing/nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, anterior nasal discharge /runny nose, thick nasal discharge, desire to clear one's throat/ dry throat, impairment of smell and impairment of sleep. Patients assessed with each of these symptoms on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).
Time frame
From enrollment to the end of treatment at 1 week2
Safety endpoint
Adverse events, if any, will be tabulated by the investigator
Time frame
From enrollment to the end of treatment at 1 weekLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
YSLab
Lead sponsor
Eclevar Medtech
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: