Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
NCT ID: NCT05499078
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-09-02
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SULFEX 13081.22
Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day).
SULFEX 13081.22
Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day). Severity of the nasal symptoms will be compared before and 6 days after spray use on a 7-point nasal symptoms scale basis.
Interventions
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SULFEX 13081.22
Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day). Severity of the nasal symptoms will be compared before and 6 days after spray use on a 7-point nasal symptoms scale basis.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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EVAMED
OTHER
Church & Dwight Company, Inc.
INDUSTRY
Responsible Party
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Locations
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Pharmacie Lair
Vire, Normandy, France
Pharmacie Plaisance
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ST-20-F10
Identifier Type: -
Identifier Source: org_study_id
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