Dry NoseNCT06110117
Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated Nose
A study testing Sterimar Stop & Protect Irritation & Dryness in people with Dry Nose, run by Church & Dwight Company, Inc. at 2 sites in Poland.
Trial summary
The goal of this clinical trial is to test symptom relief in subjects suffering from irritated or dry nasal passages. The main question it aims to answer is whether use of the nasal spray provides relief from dry nose symptoms. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dry Nose
- What is being tested?
- Sterimar Stop & Protect Irritation & Dryness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPoland
- Study dates
- 27 Oct 2023to 4 Nov 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥18 years of age;
- Subjects must have ongoing nasal irritation or dryness at Visit 1 (Day -4);
- Total Irritation Score (sum of all 12 symptom scores) must average at least 8 over the three-day run-in period (Day -3 to -1) and must be at least 8 at Visit 2 (Day 0). (Individual symptom score range is 0 - 3; Total Irritation Score range is 0 - 36.)
- Dry Nose Symptom Score must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Dry nose symptom score range is 0 - 3.)
- The score of at least two other symptoms beside dry nose must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Each symptom score range is 0 - 3.)
- Twenty-five percent of the included subjects must have ongoing nasal symptoms caused by indoor pollutants from fireplaces, candles, smoking, or cooking, verified by principal investigator;
Show all 9Show fewer
- Subjects are willing to refrain from using any medications and/or acts for relief of nasal symptoms during the whole study from Day -4 to Day 7; except for acetaminophen, ibuprofen, or vitamins;
- Subjects are willing and able to comply with the requirements of the study to use the study product according to use instructions, complete the daily symptom and product diaries and questionnaire(s), and visit the test facility as instructed;
- Subjects can read, understand, and sign an informed consent document after being advised of the nature of the study.
Who cannot join
- Currently taking any over-the-counter and prescription systemic/topical corticosteroids, antibiotics, antihistamines, cromone, nonsteroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists or topical or systemic decongestants within the two weeks prior to Visit 1;
- Currently using other nasal sprays, nasal pumps, nasal irrigation/lavage devices, or oils, creams, or gels into the nose;
- Women who are pregnant and/or breastfeeding or planning to become pregnant during the study and within 30 days after the last application of the study product;
- Have a dermatologic, respiratory, or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.) which, in the opinion of the principal investigator, could interfere with the interpretation of study results at the time of the screening visit (Day -4);
- Have a positive medical history of any significant illness within the 2 weeks prior to the screening visit (Day -4), which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
- Have a known allergy to any food or personal care products;
Show all 18Show fewer
- Have any kind of immunodeficiency;
- Have a history of sensitivity to products as related to the product being evaluated;
- Positive Coronavirus disease (COVID-19) test during the month before the study or during the study;
- Self-reported history of anaphylaxis;
- Confirmed diagnosis of urticaria or eczema;
- Confirmed diagnosis of asthma that requires more than intermittent rescue beta-agonist treatment, for example, before exercise;
- Immunotherapy during the past two years or ongoing immunotherapy;
- Recent nasal or sinus surgery within the last six months;
- Use of other nasal spray, pump, continuous positive airway pressure machine, nasal irrigation/lavage device, internal nasal gel, or nasal oil within 2 weeks before the screening visit (Day -4);
- Presence of nasal polyposis and chronic sinusitis (assessed by the PI);
- Nasal anatomic abnormality, e.g., severely deviated septum, congenital cleft lip/palate, nasal bleeding diathesis (assessed by the PI); and/or
- Any clinically significant co-morbid condition, which, in PI's opinion, may affect the subject's safety and/or participation in the study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Eurofins Dermscan Poland
Gdansk, 80-288
Centrum medyczne
Sztum, 80-400
About this study
Official title: Open Clinical Investigation to Evaluate Efficacy and Safety of the Medical Device "Sterimar Stop & Protect Irritation & Dryness" in Adults With Dry or Irritated Nose
The goal of this clinical trial is to test symptom relief in subjects suffering from irritated or dry nasal passages. The main question it aims to answer is whether use of the nasal spray provides relief from dry nose symptoms. Participants will use the product for one week and report on the severity of their symptoms before and during use.
Read the detailed description
The aim of this clinical investigation is to evaluate the efficacy and safety of a product among subjects suffering from the irritated or dry nasal mucosa triggered by any causes. Sterimar Stop \& Protect Irritation \& Dryness, similar to other nasal saline solutions, can clean the nose and eliminates impurities, restores natural moisture, and helps prevent ear, nose, and throat (ENT) disorders, consequently improving the quality of life. The test product is a seawater-based nasal spray enriched with sodium thiosulfate pentahydrate and sodium hyaluronate and is currently marketed in France. The current study is to evaluate the clinical benefits associated with using Sterimar Stop \& Protect Irritation \& Dryness in the relief of nasal dryness and irritation symptoms triggered by any causes.
60 subjects will be included in this single arm open label study.
Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day) for seven days.
- Conditions
- Dry Nose
- Being tested
- Sterimar Stop & Protect Irritation & Dryness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterimar Stop & Protect Irritation & DrynessDevice
One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Spray | Experimental | 1 to 2 sprays per nostril of Sterimar Stop \& Protect Irritation \& Dryness for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e. maximum 12 sprays per nostril each day) for seven days. Receives: Device: Sterimar Stop & Protect Irritation & Dryness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported total irritation score from baseline
Sum of scores of 12 symptoms: nasal dryness, nasal crusting, nasal bleeding, nasal itching, nasal burning, nasal obstruction, nasal pain, nasal discomfort, sneezing, reduced sense of smell, external nasal redness, and external nasal swelling. Total score ranges from 0 to 36 in 0.5 unit increments with higher scores indicating more severe symptoms. (Lower is better)
Measured: One week of product use.
Secondary outcomes (8)
Change in patient-reported symptom score from baseline for each of the 12 symptoms from baseline to day 7.
7-point scale from 0 to 3 in 0.5-unit increments with higher scores indicating more severe symptoms. (Lower is better) nasal dryness, nasal crusting, nasal bleeding, nasal itching, nasal burning, nasal congestion, nasal pain, nasal discomfort, sneezing, reduced sense of smell, external nasal redness, external nasal swelling
Measured: One week of product use.
Change in patient-reported quality of life question from baseline to day 7.
5-point scale for seven questions, plus one yes/no question. Scores range from 1 (very good) to 5 (very poor) in 1 unit increments. Yes/no on whether symptoms would have been treated if not in the study (yes means symptoms severe enough to treat).
Measured: One week of product use.
Day on which a state of well-being of nose was achieved.
Day 0 to Day 7 or not at all.
Measured: One week of product use.
Change from baseline in morning/evening total irritation and individual symptom scores.
Each symptom on a 7-point scale from 0 to 3 in 0.5-unit increments with higher scores indicating more severe symptoms. (Lower is better) Sum of symptom scores is total irritation score.
Measured: One week of product use.
Immediate relief for individual symptom scores after first product application of the day.
Each symptom on a 7-point scale from 0 to 3 in 0.5-unit increments with higher scores indicating more severe symptoms. (Lower is better)
Measured: 1 minute, 10 minutes, and 1 hour after first application on day 0 and on day 6.
Duration of relief of first dose each day.
Time between first and second product application of the day.
Measured: One week of product use.
Change from baseline in sleep disturbance scores
Assessment of quality of sleep will be evaluated by means of a questionnaire ("Quality of Sleep Questionnaire"), on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0=not at all, 1=slightly, 2=moderately and 3=severely, to be completed from Day 0 (baseline) and daily from the beginning to the end of the study.
Measured: One week of product use.
Change from baseline in examiner symptom scores for dryness, atrophy, redness, oedema, crusting, and bleeding.
Each symptom on a 7-point scale from 0 to 3 in 0.5-unit increments with higher scores indicating more severe symptoms. (Lower is better)
Measured: One week of product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start27 Oct 2023
- Primary completion15 Mar 2024
- Study completion4 Nov 2024
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
- Model description
- Subjects will be evaluated for symptom severity before and during use of the nasal spray product.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110117
- Sponsor's protocol ID
- ST-22-U62
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Clinical Investigation to Evaluate Efficacy and Safety of the Medical Device "Sterimar Stop & Protect Irritation & Dryness" in Adults With Dry or Irritated Nose
- ClinicalTrials.gov ID
- NCT06110117
- Acronym / sponsor ID
- ST-22-U62
- Conditions
- Dry Nose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 31 Oct 2023 (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.
The goal of this clinical trial is to test symptom relief in subjects suffering from irritated or dry nasal passages. The main question it aims to answer is whether use of the nasal spray provides relief from dry nose symptoms. Participants will use the product for one week and report on the severity of their symptoms before and during use.
Detailed description
The aim of this clinical investigation is to evaluate the efficacy and safety of a product among subjects suffering from the irritated or dry nasal mucosa triggered by any causes. Sterimar Stop \& Protect Irritation \& Dryness, similar to other nasal saline solutions, can clean the nose and eliminates impurities, restores natural moisture, and helps prevent ear, nose, and throat (ENT) disorders, consequently improving the quality of life. The test product is a seawater-based nasal spray enriched with sodium thiosulfate pentahydrate and sodium hyaluronate and is currently marketed in France. The current study is to evaluate the clinical benefits associated with using Sterimar Stop \& Protect Irritation \& Dryness in the relief of nasal dryness and irritation symptoms triggered by any causes.
60 subjects will be included in this single arm open label study.
Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day) for seven days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be evaluated for symptom severity before and during use of the nasal spray product.
| Arm | Type | Receives |
|---|---|---|
| Nasal Spray | Experimental | Device: Sterimar Stop & Protect Irritation & Dryness1 to 2 sprays per nostril of Sterimar Stop \& Protect Irritation \& Dryness for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e. maximum 12 sprays per nostril each day) for seven days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects ≥18 years of age;
- Subjects must have ongoing nasal irritation or dryness at Visit 1 (Day -4);
- Total Irritation Score (sum of all 12 symptom scores) must average at least 8 over the three-day run-in period (Day -3 to -1) and must be at least 8 at Visit 2 (Day 0). (Individual symptom score range is 0 - 3; Total Irritation Score range is 0 - 36.)
- Dry Nose Symptom Score must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Dry nose symptom score range is 0 - 3.)
- The score of at least two other symptoms beside dry nose must average at least 2 over the three-day run-in period and must be at least 2 at Visit 2 (Day 0). (Each symptom score range is 0 - 3.)
Key exclusion criteria (18 listed)
- Currently taking any over-the-counter and prescription systemic/topical corticosteroids, antibiotics, antihistamines, cromone, nonsteroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists or topical or systemic decongestants within the two weeks prior to Visit 1;
- Currently using other nasal sprays, nasal pumps, nasal irrigation/lavage devices, or oils, creams, or gels into the nose;
- Women who are pregnant and/or breastfeeding or planning to become pregnant during the study and within 30 days after the last application of the study product;
- Have a dermatologic, respiratory, or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.) which, in the opinion of the principal investigator, could interfere with the interpretation of study results at the time of the screening visit (Day -4);
- Have a positive medical history of any significant illness within the 2 weeks prior to the screening visit (Day -4), which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
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 |
|---|---|---|
| Sterimar Stop & Protect Irritation & DrynessOne or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for seven days. | Device | Nasal Spray |
Primary outcome
Change in patient-reported total irritation score from baseline
Time frame: One week of product use.
Sum of scores of 12 symptoms: nasal dryness, nasal crusting, nasal bleeding, nasal itching, nasal burning, nasal obstruction, nasal pain, nasal discomfort, sneezing, reduced sense of smell, external nasal redness, and external nasal swelling. Total score ranges from 0 to 36 in 0.5 unit increments with higher scores indicating more severe symptoms. (Lower is better)
8 secondary outcomes
Change in patient-reported symptom score from baseline for each of the 12 symptoms from baseline to day 7.
Time frame: One week of product use.
Change in patient-reported quality of life question from baseline to day 7.
Time frame: One week of product use.
Day on which a state of well-being of nose was achieved.
Time frame: One week of product use.
Change from baseline in morning/evening total irritation and individual symptom scores.
Time frame: One week of product use.
Immediate relief for individual symptom scores after first product application of the day.
Time frame: 1 minute, 10 minutes, and 1 hour after first application on day 0 and on day 6.
Duration of relief of first dose each day.
Time frame: One week of product use.
Change from baseline in sleep disturbance scores
Time frame: One week of product use.
Change from baseline in examiner symptom scores for dryness, atrophy, redness, oedema, crusting, and bleeding.
Time frame: One week of product use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Dry Nose
Recruiting
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Dry Eye
Not yet recruiting
Clinical Evaluation of the Efficacy of a Nasal Spray in the Treatment of Nasal Dryness
Nasal Dryness
RecruitingPhase 4
Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment
Dry Eye, Meibomian Gland Dysfunction
Not yet recruiting
Diagnostic Efficacy of CDA Nasal Provocation Test in Patients With IR
Chronic Rhinitis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterimar Stop & Protect Irritation & Dryness in people with Dry Nose, run by Church & Dwight Company, Inc. at 2 sites in Poland.
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 9 inclusion and 18 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: finished, as of the sponsor's last update on 20 Nov 2024. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported total irritation score from baseline (time frame: One week of product use.). 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 20 Nov 2024.