NCT05853224

An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel

An Interventional, Pre-Market, Double-Blinded, Controlled, Two Stages Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel (With and Without Lidocaine) for the Treatment of Soft Tissue Deficits

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Biopolimeri Srl · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.

Detailed description

The performance of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine), for the correction of congenital and acquired deficits of soft tissue, will be evaluated using the change from baseline to V3 in the Wrinkle Severity Rating Scale (WSRS) for 26 mg/ml and 18mg/ml CLHA formulations and in the Lip Fullness Scale (LFS) for 20 mg/ml CLHA formulation. The duration of the aesthetic effect of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) for the correction of NLFs, perioral wrinkles and lips augmentation, will be assessed using the mean of the absolute change from baseline to each follow up visit in WSRS and LFS score. WSRS and LFS will be assessed by the evaluating investigator who will be different by the treating investigator. The aesthetic appearance of the Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using the Global Aesthetic Improvement Scale (GAIS) at each visit. The GAIS will be completed by both the subjects and the evaluating investigators; The volume of material required to achieve an optimal correction result will be assessed at baseline and at optional touch up; The pain intensity after injection of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed using a Numerical Rating Scale (NRS) 2 hours after the injection; The patient satisfaction and the usability of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be evaluated with a specific questionnaire, completed by the Principal Investigator. The Safety of Crosslinked Hyaluronic Acid Hydrogel (with and without Lidocaine) will be assessed by facial examination and vital signs over the duration of the study. Adverse events and serious adverse events will be collected at each planned visit into a diary dispensed to patients.

Conditions

• Dermal Filler
• Volume Deficiency of the Midface

Interventions

Type	Name	Description
DEVICE	Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine	The injection should be performed at variable depth of the skin (dermal or subdermal), depending on the area to be treated and on the product variants, in accordance to the IFU of the IPs

Timeline

• Start date: 2022-04-02
• Primary completion: 2023-12-02
• Completion: 2023-12-02
• First posted: 2023-05-10
• Last updated: 2023-05-10

Locations

1 site across 1 country: Italy