Clinical trial NCT05499078: Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
Official title: Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Nose
Nose Irritation
Keywords: Nasal Obstruction
Nasal Obstruction, Bilateral
Nasal Bleeding
Nasal Passage Irritation
Nasal Pain
Nasal Crusting
Nasal Itching
Nasal Burning
Nasal Discomfort
Sneezing
Airborne particles
Mucous Membrane
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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 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 questionnaires filling.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

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

Primary outcomes:
measure: Nasal symptoms severity
timeFrame: 6 days
Secondary outcomes:
measure: Safety data on SULFEX 13081.22 nasal spray
timeFrame: 6 days
measure: Performance of SULFEX 13081.22 nasal spray
timeFrame: 6 days
measure: Nasal symptoms relief/change
timeFrame: 6 days
measure: Onset of relief
timeFrame: immediate or semi-immediate
measure: Duration of relief (long lasting).
timeFrame: 6 days
measure: Previous nasal state of well-being assessment
timeFrame: 6 days
measure: Medical device usability
timeFrame: 6 days
measure: Product attributes
timeFrame: 6 days
measure: Patient satisfaction
timeFrame: 6 days
Other outcomes:
Locations:
city: Vire
country: France
facility: Pharmacie Lair
state: Normandie
city: Paris
country: France
facility: Pharmacie Plaisance
Study officials:
References: