Clinical Evaluation of the Efficacy of a Nasal Spray in the Treatment of Nasal Dryness
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
Gender: female and/or male.
The physician's score for at least two symptoms, in addition to a dry nose, must average at least 2 at the enrolment visit (Day 0), for a minimum total score of 6.
Subjects agree to refrain from taking any medication and/or taking any action to relieve nasal symptoms throughout the study, from Day -4 to Day 7, apart from acetaminophen.
Autonomous adult, or minor with the consent of their legal representative.
Disqualifiers
Subjects taking anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), or topical or systemic decongestants within two weeks prior to Visit 1 and during the study.
Subjects using other nasal sprays, nasal pumps, nasal irrigation/rinsing devices, or oils, creams, or gels in the nose within two weeks prior to Visit 1 and during the study.
Subjects with a history of sensitivity to products related to the product being evaluated.
Subjects with any clinically significant comorbid condition that, in the opinion of the principal investigator, could affect the subject's safety and/or participation in the study.
Trial design
Design model
Single group
Treatments tested in this trial
Spray pompe nasal
DeviceDosage: 2 sprays per nostril
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Nasal sprayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of the nasal dryness symptoms
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
Day 0 - Day 0 immediately after first use - Day 7Secondary outcomes
1
Improvement of the total perceive Nasal symptom relief
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
Day 0 - Day 0 immediately after first use - Day 72
Incidence of Adverse Events
Adverse events, if any, will be tabulated by the investigator
Time frame
through study completion, an average of 7 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
YSLab
Lead sponsor
Eurofins
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: