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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterimar Stop & Protect Irritation & Dryness | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | One week of product use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Gdansk | 80-288 | Poland | |||
| Centrum medyczne |
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| ID | Term |
|---|---|
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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Subjects will be evaluated for symptom severity before and during use of the nasal spray product.
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| 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). | 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. | 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. | 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) | 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. | 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. | 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) | One week of product use. |
| Sztum |
| 80-400 |
| Poland |