Dry NoseNCT05499078
Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
A study testing SULFEX 13081.22 in people with Dry Nose and Nose Irritation, run by Church & Dwight Company, Inc. at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Nose, Nose Irritation
- What is being tested?
- SULFEX 13081.22
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Sep 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Pharmacie Plaisance
Paris, 75014
Timothé GOUDOT, Pharmacist, 0033145431554, plaisancepharmacie@gmail.com
- Recruiting
Pharmacie Lair
Vire, Normandy, 14500
Harmonie LE BORDAIS, Pharmacist, 0033231680077, harmonielebordais@gmail.com
About this study
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.
Read the 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.
- Conditions
- Dry Nose, Nose Irritation
- Being tested
- SULFEX 13081.22
- 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
- Medical subject headings
- Nasal Obstruction, Epistaxis, Sneezing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SULFEX 13081.22Device
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.
| Study group | Role | What they receive |
|---|---|---|
| SULFEX 13081.22 | Experimental | Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day). Receives: Device: SULFEX 13081.22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (9)
Safety data on SULFEX 13081.22 nasal spray
To collect safety data on the SULFEX 13081.22 nasal spray after 6 days of use (with at least 1 spray use a day). Proportion of patients with at least one adverse device effect occurred between the first and the last spray use.
Measured: 6 days
Performance of SULFEX 13081.22 nasal spray
To assess the performance of the SULFEX 13081.22 nasal spray, on the following nasal symptoms, after 6 days of use (with at least 1 spray use a day).
- Nasal crusting
- Nasal bleeding
- Nasal itching
- Nasal burning
- Nasal obstruction
- Nasal pain
- Nasal discomfort
- Sneezing
- Reduced sense of smell
- External nasal redness
- External nasal swelling Performance on a particular symptom will be verified if there is a decrease of at least 0.5 point in the symptom score between Day 0 and Day 6.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
Measured: 6 days
Nasal symptoms relief/change
To assess nasal symptoms relief/reduction each day, from Day 0 to Day 6. Assessment of nasal symptoms mean scores at D0 / D1 / D2 / D3 / D4 / D5 and D6.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
Measured: 6 days
Onset of relief
To assess onset of relief (immediate or semi-immediate relief). Proportion of patients with immediate or semi-immediate relief.
An immediate relief is defined as a nasal symptom improvement at 1 min or 10 min after the 1st spray use of the day. A semi-immediate relief is defined as a nasal symptom improvement at 1 hour after the 1st spray use of the day.
Measured: immediate or semi-immediate
Duration of relief (long lasting).
To assess duration of relief (long lasting). This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
Measured: 6 days
Previous nasal state of well-being assessment
To assess the day at which patients regained their previous nasal state of well-being (feeling of well-being). Day at which the patient regained his/her previous nasal state of well-being (feeling of well-being) + proportion of patients with an overall relief.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.
Measured: 6 days
Medical device usability
To assess the medical device usability. assessment of the proportion of patients that would agree with each usability criteria on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.
Measured: 6 days
Product attributes
To assess product attributes of the medical device. Assessment of proportion of patients that would agree with each product attribute on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.
Measured: 6 days
Patient satisfaction
To assess patient satisfaction regarding the medical device. Assessment of Proportion of patients satisfied with the medical device use on a 5-point scale basis.
- Proportion of patient liking the medical device on a 5-point scale basis + aspect that is most liked and disliked about the medical device.
- Proportion of patients wishing to continue using the medical device on a 5-point scale basis.
- Proportion of patients that would recommend the medical device on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start2 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry NoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499078
- Sponsor's protocol ID
- ST-20-F10
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose
- ClinicalTrials.gov ID
- NCT05499078
- Acronym / sponsor ID
- ST-20-F10
- Conditions
- Dry Nose, Nose Irritation
- Keywords
- Nasal Obstruction, Nasal Obstruction, Bilateral, Nasal Bleeding, Nasal Passage Irritation, Nasal Pain, Nasal Crusting, Nasal Itching, Nasal Burning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SULFEX 13081.22 | Experimental | Device: SULFEX 13081.22Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SULFEX 13081.22Patients 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. | Device | SULFEX 13081.22 |
Primary outcome
Nasal symptoms severity
Time frame: 6 days
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.
9 secondary outcomes
Safety data on SULFEX 13081.22 nasal spray
Time frame: 6 days
Performance of SULFEX 13081.22 nasal spray
Time frame: 6 days
Nasal symptoms relief/change
Time frame: 6 days
Onset of relief
Time frame: immediate or semi-immediate
Duration of relief (long lasting).
Time frame: 6 days
Previous nasal state of well-being assessment
Time frame: 6 days
Medical device usability
Time frame: 6 days
Product attributes
Time frame: 6 days
Patient satisfaction
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SULFEX 13081.22 in people with Dry Nose and Nose Irritation, run by Church & Dwight Company, Inc. at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothé GOUDOT, Pharmacist (0033145431554, plaisancepharmacie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal symptoms severity (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.