Clinical Evaluation of the Efficacy of a Nasal Spray in the Treatment of Nasal Dryness

Официальное название

Clinical Evaluation of the Efficacy of a Nasal Spray Based on Isotonic Seawater and Hyaluronic Acid in the Treatment of Nasal Dryness

Обзор

The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.

Вмешательства

• Устройство Spray pompe nasal
  Dosage: 2 sprays per nostril

Первичные конечные точки

• Improvement of the nasal dryness symptoms [Срок оценки: Day 0 - Day 0 immediately after first use - Day 7]

Вторичные конечные точки (2)

• Improvement of the total perceive Nasal symptom relief [Срок оценки: Day 0 - Day 0 immediately after first use - Day 7]
• Incidence of Adverse Events [Срок оценки: through study completion, an average of 7 days]

Критерии участия

Критерии включения

• Gender: female and/or male.
• Age: adults and children from 6 years old:
• The physician's score for at least two symptoms, in addition to a dry nose, must average at least 2 at the enrolment visit (Day 0), for a minimum total score of 6.
• Subjects agree to refrain from taking any medication and/or taking any action to relieve nasal symptoms throughout the study, from Day -4 to Day 7, apart from acetaminophen.
• Autonomous adult, or minor with the consent of their legal representative.
• Subject and/or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
• Subject and/or Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.
• Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use.
• Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.

Критерии исключения

• Subjects taking anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), or topical or systemic decongestants within two weeks prior to Visit 1 and during the study.
• Subjects using other nasal sprays, nasal pumps, nasal irrigation/rinsing devices, or oils, creams, or gels in the nose within two weeks prior to Visit 1 and during the study.
• Subjects with a history of sensitivity to products related to the product being evaluated.
• Subjects with any clinically significant comorbid condition that, in the opinion of the principal investigator, could affect the subject's safety and/or participation in the study.
• Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
• Person refusing to sign the informed consent form prior to the study.
• Person participating or having participated in any other clinical study within the 30 days preceding the study.
• Person participating in any other clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07657247 · STUU526AA0790

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗