Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853224
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-03-28
Brief Title:
An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel
Sponsor:
Biopolimeri Srl
Organization:
Biopolimeri Srl
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgml and 18mgml CLHA formulations and in the Lip Fullness Scale LFS for 20 mgml 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None