NCT07657247尚未招募不适用
Clinical Evaluation of the Efficacy of a Nasal Spray Based on Isotonic Seawater and Hyaluronic Acid in the Treatment of Nasal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- YSLab
- 入组人数
- 60
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究者
相似试验
招募中
2 期
Phase II Trial of PRT-064040 Nasal Spray for the Treatment of Migraine in AdultsMigraineNCT07304518Sichuan Purity Pharmaceutical Technology Co., Ltd.456
已完成
2 期
Environmental Exposure Unit Trial in Subjects With Ragweed-induced Allergic RhinitisAllergic Rhinitis Due to AllergensRhinitis AllergicAllergic RhinitisNCT07556393Inimmune Corporation78
招募中
2 期
Nasal spray in sinusitis and coldCTRI/2024/07/070306Dr VIDYA R E40
尚未招募
1 期
Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic SinusitisNCT07635459The First Affiliated Hospital of Xinxiang Medical College108
尚未招募
1 期
Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic SinusitisNCT07635433The First Affiliated Hospital of Xinxiang Medical College108