Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray

NCT07204158 | Not Yet Recruiting

• 1 other identifier: 2025-A00666-43
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasal Dryness

Outcome Measures

Primary Outcomes (1)

• Improvement of the nasal dryness symptoms

  The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).

  From enrollment to the end of treatment at 1 week

Secondary Outcomes (2)

• Improvement of the total perceive Nasal symptom relief

  From enrollment to the end of treatment at 1 week

• Safety endpoint

  From enrollment to the end of treatment at 1 week

Study Arms (1)

subject using the device

EXPERIMENTAL

Device: Spray pompe nasal confort

Interventions

Spray pompe nasal confort DEVICE

Seawater solution with hyaluronan

subject using the device

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IC1. Male, female over 6 years old.
• IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
• IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
• IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
• IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
• IC6. Signed informed consent (by patient and/or parent/legal guardian).

You may not qualify if:

• EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
• EC2. Patient with known hyper sensibility to the study treatment;
• EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
• EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC5. Patients with a positive medical history of any significant illness in the 2 weeks preceding the study, which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC6. Patients with nasal anatomical anomalies, e.g., severely deviated septum, congenital cleft lip/palate, nasal hemorrhagic diathesis (assessed by principal investigator);
• EC7. Patient that uses cocaine or other inhaled drugs
• EC8. Patients with any clinically significant co-morbid condition that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
• EC10. Women of childbearing age (except menopausal, hysterectomized, and sterilized) are not using effective contraception (oral contraceptives, intra-uterine devices, contraceptive implants, or condoms);
• EC11. A person belonging to a population referred to in articles 64 (incapacitated subjects), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in an emergency) of the MDR 2017/745.

Sponsors & Collaborators

• YSLab: lead
• Eclevar Medtech: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 2, 2025
• Study Start: October 7, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10