Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05499078

ST-20-F10

Ages > 18
All Genders

Study Summary

As the medical device is CE marked, the objective of this study is to provide performance and safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient > 18 years of age.
Patient voluntarily buying the spray and using it for him/herself.
Patient with nasal dryness and/or nasal irritation.
Patient informed of the study, who gave its express consent (free, informed, written)before any specific procedure to the study.
Patient meeting study's requirements regarding follow-up schedule and questionnairesfilling.
Patient affiliated to a social security scheme.

Exclusion

Exclusion Criteria:

Patient currently taking corticosteroids or antibiotics or antihistamines orNonsteroidal anti-inflammatory drugs (NSAIDs) or topical decongestants or systemicdecongestants
Patient currently using other nasal sprays, nasal pumps, nasal irrigation/lavagedevice, or oils, creams or gels into the nose.
Patient deprived of freedom or subject to legal protection measures.
Pregnant or breastfeeding woman.

Study Design

September 02, 2022

December 31, 2023

Study Description

Every day, people breathe large amounts of air which contain all kinds of particles. Nasal cavities are the first site of airway protection against airborne particles. The mucociliary apparatus (a layer of tiny moving hairs and mucus which covers the mucous membrane inside the nose) is the first line of defence of the upper airways and helps to eliminate these particles. If this defence mechanism is altered, it may cause nasosinusal damage or irritation and be unable to protect the respiratory system.

Moreover, external factors such as pollution or dry air may affect the function of the nose. The same is true for chronic and/or recurrent infections. These various factors can cause irritation or dryness of the nasal mucosa, often causing inflammation with feelings of congestion, discomfort or burning of the nasal mucosa, sometimes with bleeding or painful crusting.

SULFEX 13081.22 is a nasal spray, CE marked and commercialized since 2014. SULFEX spray soothes, restores and provides long-lasting/intense hydration of uncomfortable, painful or sore nasal mucosa caused by excessive dryness. It also contributes towards cell regeneration for faster healing and optimum relief and protects against new external attacks.The anti-reflux valve system prevents any contamination of the solution, even after the bottle has been opened, which means the formula remains 100% aseptic.