CompletedNot Applicable

Investigation to Evaluate the Clinical Safety and Effectiveness of WET® Gel

Italy58 participantsStarted 2020-01-31

Plain-language summary

The objective of the investigation is to assess the clinical safety and effectiveness of WET® gel in the treatment of nasal dryness, following maximum two weeks of treatment.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Patients having undergone the informed consent process and having signed an approved consent form;
✓. Male and female outpatients, aged ≥ 18 years;
✓. Patients with nasal dryness of moderate-severe intensity, defined as a score ≥ 4 in a 0-10 numeric rating scale (NRS), with or without superficial microlesions;
✓. Patients with absence of nasal discharge;
✓. Patients having not taken oral or intranasal decongestants, antihistamines (by any route), corticosteroids (by any route), intranasal anticholinergics, leukotriene inhibitors, mucolytics (by any route), sodium cromoglycate (by any route) in the 4 weeks preceding the screening/baseline visit and agree not to take them during the investigation;
✓. Patients with a cooperative attitude and ability to be trained to use correctly the investigational medical device, to adhere to the dosing and visit schedules, and agree to record symptoms' severity scores and use of the investigational device in a daily diary;
✓. If female of child-bearing potential, they must have a negative urine pregnancy test at the screening visit and use a reliable form of contraception for a least 1 month prior to Screening and throughout the investigation. Note: to be considered females of non-child-bearing potential, females must be surgically sterile or postmenopausal as documented in medical history for at least 1 year.

Exclusion criteria

✕. Patients with atopic or non-atopic rhinosinusitis in active phase;
✕. Patients with anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps) that would interfere with nasal airflow;
✕. Patients with a medical history of nasal or sinus surgery in the previous 12 months;
✕. Patients with upper respiratory tract or sinus infection;
✕. Patients with rhinitis medicamentosa;
✕. Patients with epistaxis;
✕. Patients having received treatment with oral or intranasal decongestants, anti-histamines (by any route), corticosteroids (by any route), intranasal anticholinergics, leukotriene inhibitors, mucolytics (by any route), sodium cromoglycate (by any route) in the 4 weeks preceding the screening/baseline visit;
✕. Patients having received treatment with antibiotics (by any route) in the 4 weeks preceding the screening/baseline visit;

What they're measuring

General safety and tolerability of WET® gel

Timeframe: 15 days (the entire study duration)

Trial details

NCT IDNCT04358055

SponsorFidia Farmaceutici s.p.a.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-26

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