Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 3, 2023
July 1, 2022
1.1 years
July 6, 2022
March 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nasal symptoms severity
Severity of the following nasal symptoms will be compared before and 6 days after spray use on a 7-point scale basis. * Nasal irritation * Nasal dryness Performance on Irritation and Dryness will be verified if there is a decrease of at least 0.5 point on at least one of the two symptom scores between Day 0 and Day 6. This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
6 days
Secondary Outcomes (9)
Safety data on SULFEX 13081.22 nasal spray
6 days
Performance of SULFEX 13081.22 nasal spray
6 days
Nasal symptoms relief/change
6 days
Onset of relief
immediate or semi-immediate
Duration of relief (long lasting).
6 days
- +4 more secondary outcomes
Study Arms (1)
SULFEX 13081.22
EXPERIMENTALPatients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day).
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Church & Dwight Company, Inc.lead
- EVAMEDcollaborator
Study Sites (2)
Pharmacie Lair
Vire, Normandy, 14500, France
Pharmacie Plaisance
Paris, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
August 12, 2022
Study Start
September 2, 2022
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
March 3, 2023
Record last verified: 2022-07