Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT07273318
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old;
2. Patients affected by dry nose;
3. Willing to comply with study requirements, using the tested products for 14 consecutive days;
4. Readiness not to participate in another clinical study during this study;
5. Commitment to using contraceptive methods (for women of childbearing age only);
6. Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline (only for women in childbearing age);
7. Written informed consent by the participant.
Exclusion Criteria:
1\. Known allergy or hypersensitivity to the components of the OSMONAR or of saline solution; 4. Lesions/infections in the nasal area;
5\. Use of preparations that may influence the study outcome within the last 2 weeks prior to baseline and during the study (e.g. antibiotics, corticosteroids etc.);
6\. History or presence of any other clinically significant known (self-reported) condition /disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject;
7\. Pregnancy, nursing or within first 3 months post-partum;
8\. History of or current abuse of drugs, alcohol or medication;
9\. Participation in another study during the last 30 days prior to baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07273318
Study Brief:
Protocol Section:
NCT07273318