Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05499078
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2022-07-06
Brief Title:
Pilot Study to Assess Performance and Safety of SULFEX 1308122 Nasal Spray in Patients With Dry or Irritated Nose
Sponsor:
Church Dwight Company Inc
Organization:
Church Dwight Company Inc
Study Overview
Official Title:
Pilot Study to Assess Performance and Safety of SULFEX 1308122 Nasal Spray in Patients With Dry or Irritated Nose
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As the medical device is CE marked the objective of this study is to provide performance and safety data on SULFEX 1308122 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 andor 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 1308122 is a nasal spray CE marked and commercialized since 2014 SULFEX spray soothes restores and provides long-lastingintense 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 attacksThe 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 1308122 nasal spray as close as possible to the routine care
Moreover external factors such as pollution or dry air may affect the function of the nose The same is true for chronic andor 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 1308122 is a nasal spray CE marked and commercialized since 2014 SULFEX spray soothes restores and provides long-lastingintense 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 attacksThe 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 1308122 nasal spray as close as possible to the routine care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None