Nose Dry Feeling ofNCT04358055
Investigation to Evaluate the Clinical Safety and Effectiveness of WET® Gel
A study testing WET® gel in people with Nose Dry Feeling of, run by Fidia Farmaceutici s.p.a. at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nose Dry Feeling of
- What is being tested?
- WET® gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesItaly
- Study dates
- 31 Jan 2020to 26 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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;
- Patients with history of alcoholism or drug dependence;
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;
- Patients who have used any investigational drug or device, or have participated in an investigational protocol in the past 3 months;
- Patients who have been previously enrolled in this investigation.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
ATS Insubria
Alzate Brianza, 22040
ATS Insubria
Como, Via Varese 11, 22100
ATS Insubria
Erba, 22036
ATS Insubria
Porlezza, 22018
About this study
Official title: Open-label, Multicenter, Prospective Investigation to Evaluate the Clinical Safety and Effectiveness of WET® Gel, Containing Hydeal-D®, an Ester of Hyaluronic Acid, in the Treatment of Nasal Dryness
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.
Read the detailed description
The objective of the project is to perform a post marketing clinical study to confirm safety and clinical effectiveness of WET® gel in the treatment of nasal dryness.
This investigation will be carried out following the CE marking of the WET® gel device and is mainly intended to answer questions relating to clinical safety or performance (i.e. residual risks) of the device when used in accordance whit its approved labelling.
The study is also aimed at defining the optimal dose regimen of WET® gel.
- Conditions
- Nose Dry Feeling of
- Being tested
- WET® gel
- Keywords
- dryness, nasal, gel, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WET® gelDevice
Also called WET® gel, containing Hydeal-D®, an ester of hyaluronic acid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: WET® gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days (the entire study duration)
Secondary outcomes (8)
Change in nasal dryness
Changes from baseline in score (0-10 NRS) of nasal dryness (morning, evening and daily mean) at any post-baseline time points
Measured: 15 days (the entire study duration)
Percentage of patients with resolution of nasal dryness
Percentage of patients with resolution of nasal dryness (defined as a score of 0 in the NRS for ≥ 3 consecutive days)
Measured: 15 days (the entire study duration)
Time to resolution of nasal dryness
Time to resolution of nasal dryness (defined as a score of 0 in the NRS for ≥ 3 consecutive days)
Measured: 15 days (the entire study duration)
Changes from baseline of nasal crusting
Changes from baseline in score (0-10 NRS) of nasal crusting (morning, evening and daily mean) at any post-baseline time point
Measured: 15 days (the entire study duration)
Changes from baseline of nasal itching
Changes from baseline in score (0-10 NRS) of nasal itching (morning, evening and daily mean) at any post-baseline time point
Measured: 15 days (the entire study duration)
Changes from baseline of nasal burning
Changes from baseline in score (0-10 NRS) of nasal burning (morning, evening and daily mean) at any post-baseline time point
Measured: 15 days (the entire study duration)
Changes from baseline of nasal obstruction
Changes from baseline in score (0-10 NRS) of nasal obstruction (morning, evening and daily mean) at any post-baseline time point
Measured: 15 days (the entire study duration)
Compliance to treatment with WET® gel
Compliance to treatment according to patient diary
Measured: 15 days (the entire study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start31 Jan 2020
- Primary completion26 Jun 2021
- Study completion26 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose Dry Feeling ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Giordan, Study director, Fidia Farmaceutici s.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358055
- Sponsor's protocol ID
- QQ23_19_01
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Prospective Investigation to Evaluate the Clinical Safety and Effectiveness of WET® Gel, Containing Hydeal-D®, an Ester of Hyaluronic Acid, in the Treatment of Nasal Dryness
- ClinicalTrials.gov ID
- NCT04358055
- Acronym / sponsor ID
- QQ23_19_01
- Conditions
- Nose Dry Feeling of
- Keywords
- dryness, nasal, gel, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the project is to perform a post marketing clinical study to confirm safety and clinical effectiveness of WET® gel in the treatment of nasal dryness.
This investigation will be carried out following the CE marking of the WET® gel device and is mainly intended to answer questions relating to clinical safety or performance (i.e. residual risks) of the device when used in accordance whit its approved labelling.
The study is also aimed at defining the optimal dose regimen of WET® gel.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WET® gel | Experimental | Device: WET® gelAt 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WET® gelAlso: WET® gel, containing Hydeal-D®, an ester of hyaluronic acidIn 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. | Device | WET® gel |
Primary outcome
General safety and tolerability of WET® gel
Time frame: 15 days (the entire study duration)
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.
8 secondary outcomes
Change in nasal dryness
Time frame: 15 days (the entire study duration)
Percentage of patients with resolution of nasal dryness
Time frame: 15 days (the entire study duration)
Time to resolution of nasal dryness
Time frame: 15 days (the entire study duration)
Changes from baseline of nasal crusting
Time frame: 15 days (the entire study duration)
Changes from baseline of nasal itching
Time frame: 15 days (the entire study duration)
Changes from baseline of nasal burning
Time frame: 15 days (the entire study duration)
Changes from baseline of nasal obstruction
Time frame: 15 days (the entire study duration)
Compliance to treatment with WET® gel
Time frame: 15 days (the entire study duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Giordan study director
Fidia Farmaceutici s.p.a.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WET® gel in people with Nose Dry Feeling of, run by Fidia Farmaceutici s.p.a. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General safety and tolerability of WET® gel (time frame: 15 days (the entire study duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.