Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 7:13 AM
Study NCT ID:
NCT03273556
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
Sponsor:
Derming SRL
Organization:
Study Overview
Official Title:
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: 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 0.3%: 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 0.3% (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 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain 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 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain 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?: