NCT04358055

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	WET® gel	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.

Timeline

• Start date: 2020-01-31
• Primary completion: 2021-06-26
• Completion: 2021-06-26
• First posted: 2020-04-22
• Last updated: 2023-10-23

Locations

4 sites across 1 country: Italy