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

NCT04358055 | Completed

• 1 other identifier: QQ23_19_01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Nose Dry Feeling of

Keywords

dryness; nasal; gel; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• General safety and tolerability of WET® gel

  The primary objective of the investigation is to evaluate the general safety and local tolerability of WET® gel in the primary endpoint incidence of treatment-related treatment-emergent adverse events (TEAEs). Endpoint: Incidence of local and general treatment-related TEAEs during the entire investigation duration.

  15 days (the entire study duration)

Secondary Outcomes (8)

• Change in nasal dryness

  15 days (the entire study duration)

• Percentage of patients with resolution of nasal dryness

  15 days (the entire study duration)

• Time to resolution of nasal dryness

  15 days (the entire study duration)

• Changes from baseline of nasal crusting

  15 days (the entire study duration)

• Changes from baseline of nasal itching

  15 days (the entire study duration)

Study Arms (1)

WET® gel

EXPERIMENTAL

At the screening/baseline visit (Visit 1, Day 1), eligible patients will be assigned to treatment with WET® gel, at the dose of 3-4 nasal applications/day (according to necessity), 1or 2 puff/nostril, for maximum 14 days. Treatment will be administered according to patient's need without any relation with the time of the day (i.e. day time or night time administration), however within a maximum of 4 applications/day, which must include one administration in the morning upon awakening and one administration in the evening before retiring to bed.

Device: WET® gel

Interventions

WET® gel DEVICE

In each application, a puff should be administered in each nostril every two seconds, with minimal inspirations, up to a sensation of lubrication in the external conduct is perceived. Then the patient should proceed with short inspirations and light touching of ala of the nose, to favour the distribution of the gel. A maximum of 4 erogations (2/nostril) is allowed in each application session.

Also known as: WET® gel, containing Hydeal-D®, an ester of hyaluronic acid

WET® gel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients currently undergoing a progressive course of immunotherapy(hyposensitization);
• Patients having performed a sinus lavage in the 2 weeks preceding the screening/baseline visit;
• Patients with known or suspected allergy, hypersensitivity or intolerance to hyaluronic acid and/or any other component of the investigational device;
• Patients with presence of any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex;
• Patients with presence of other serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, or neurological disease that could interfere with the outcome of the investigation or the patient's ability to comply with investigation requirements;
• Patients who have been diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas);
• Pregnant (positive urine test) or breastfeeding women, or planning to become pregnant during the investigation;

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (4)

ATS Insubria

Como, Via Varese 11, 22100, Italy

Location

ATS Insubria

Alzate Brianza, 22040, Italy

Location

ATS Insubria

Erba, 22036, Italy

Location

ATS Insubria

Porlezza, 22018, Italy

Location

Study Officials

• Nicola Giordan

  Fidia Farmaceutici s.p.a.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: April 22, 2020
• Study Start: January 31, 2020
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)