on-interventional Post-Market Clinical Follow-up Study to endorse performance and safety of Weiche Nasensalbe nach Dr. Bader® for moistening the dry nasal mucosa in the anterior area of the nose
- Conditions
- Dry nose and/or nasal mucosa
- Registration Number
- DRKS00032964
- Lead Sponsor
- Hälsa Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
1.Adult study participants (= 18 years) suffering from a dry nose, (e.g. patients suffering from rhinitis sicca [anterior], allergic rhinitis, or participants predisposed by age or working or living conditions, patients using supportive nasal administration of oxygen, patients suffering from obstructive sleep apnoea, patients after head and neck radiotherapy)
2.Indication for use of Weiche Nasensalbe nach Dr. Bader® on the anterior part of the nose, according to the IFU and the investigator’s judgement
3.A nasal dryness” severity of = 3 measured on a VAS scale.
4.Written informed consent
5.Willingness, not to use any other prescription and non-prescription medication or medical device for treatment of symptoms of nasal dryness during the Post-Market Clinical Follow-up Study
1.Any clinically relevant disease or structural defect that might interfere with clinical evaluations or that could affect the outcome of the study
2.Hypersensitivity or allergy to any of the product ingredients
3.Patients with injured or freshly operated nasal mucosa
4.Bedridden patients
5.Treatment with any kind of rhinological agent or necessity of any concomitant treatment that could affect the outcome of the study (e.g. nasal or systemic corticosteroids, antimicrobials) within the last 7 days
6.Study participants not able to follow study procedures, e.g. due to language barrier or mental /psychological disorders
7.Study participants under any clinical investigation in the last 30 days
8.Subjects not able or willing to sign informed consent.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Due to the exploratory approach of the PMCF study, all parameters are listed here without differentiation into primary and secondary endpoints:<br>-Change of symptom severity for nasal dryness<br>-Change of symptom severity for dryness related symptomatology<br>-Assessment of sensory perceptions and moistening effect of the ointment<br>-Global assessment of performance by study participant (i.e. moistening effect and preventive effect with regard to drying out of the nasal mucosa)<br>-Global assessment of satisfaction and quality of life by study participant<br>-Participant’s willingness to recommend product to a friend<br>- Documentation of safety related findings
- Secondary Outcome Measures
Name Time Method Due to the exploratory approach of the PMCF study, all parameters are listed under primary endpoints without differentiation into primary and secondary endpoints.