Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03273556
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2017-09-01
Brief Title:
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin EV With and Without Lidocaine 03
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin EV With and Without Lidocaine 03 Comparison Within Subjects Half Face Method
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Evaluation of the filler performance on the nasolabial folds of Aliaxin EV with and without lidocaine 03 comparison within subjects half face method
Detailed Description:
Comparative randomized mono-centre spontaneous trial under dermatological control that foresaw the comparison within subjects of the investigational product versus investigational product with Lidocaine 03 half face method assignation of right or left face side to the two injective treatments was choose by the Investigator according to a previously defined randomisation list
Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin EV Essential Volume in women aged 40-65 years
It was also aim of this study to show if the addition of Lidocaine 03 to the investigational product extemporaneous mixture could have reduced the discomfortpain sensation perceived by the subject during the injection procedure without altering the aesthetic performance
Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin EV Essential Volume in women aged 40-65 years
It was also aim of this study to show if the addition of Lidocaine 03 to the investigational product extemporaneous mixture could have reduced the discomfortpain sensation perceived by the subject during the injection procedure without altering the aesthetic performance
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?:
None
Is an FDA AA801 Violation?:
None