Dry nose and/or nasal mucosa
Conditions
Interventions
Group 1: Soft nasal ointment according to Dr. Bader®, application according to the instructions for use, for a period of max. 30 days
Sponsors
Hälsa Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to the exploratory approach of the PMCF study, all parameters are listed here without differentiation into primary and secondary endpoints: -Change of symptom severity for nasal dryness -Change of symptom severity for dryness related symptomatology -Assessment of sensory perceptions and moistening effect of the ointment -Global assessment of performance by study participant (i.e. moistening effect and preventive effect with regard to drying out of the nasal mucosa) -Global assessment of satisfaction and quality of life by study participant -Participant’s willingness to recommend product to a friend - Documentation of safety related findings | — |
Secondary
| Measure | Time frame |
|---|---|
| Due to the exploratory approach of the PMCF study, all parameters are listed under primary endpoints without differentiation into primary and secondary endpoints. | — |
Countries
Germany
Contacts
Public ContactCarina Nitschinger
BioTeSys GmbH
Outcome results
None listed