Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337747
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2023-05-23
Brief Title:
Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs Extended Temporal Fossa Hairline
Sponsor:
Erevna Innovations Inc
Organization:
Erevna Innovations Inc
Study Overview
Official Title:
A Prospective Randomized-controlled Trial Comparing Superficial Injections With Poly-L-Lactic Acid in the Temporal Fossa Versus Extended Temporal Fossa Hairline
Status:
COMPLETED
Status Verified Date:
2023-06
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 use of poly-L-Lactic acid PLLA has demonstrated significant improvement in multiple facial and body regions Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries Furthermore the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured Therefore this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows
Detailed Description:
Non-invasive treatment of volume loss is one of the most common aesthetic treatments performed worldwide Poly-L-lactic acid has been used as a skin filler since 1999 in Europe and since 2004 in the United States Vlegger 2014 as well as in several medical areas for over three decades Chen 2014 Vlegger 2006 In addition poly-L-lactic acid is widely used in several countries for facial rejuvenation with extensive documentation of their efficacy and safety in this context Vlegger 2014 Sculptra Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid carboxymethylcellulose non-pyrogenic mannitol and sterile water for injection Sculptra Aesthetic is available in 3675 mg dose vials and is to be reconstituted prior to use by the addition of 8 mL of sterile water 1mL xylocaine for injection to form a sterile nonpyrogenic suspension
Sculptra Aesthetic is indicated for increasing the volume of depressed areas particularly to correct skin depressions such as in skin creases wrinkles folds scars and for skin aging It is also suitable for large volume corrections of the signs of facial fat loss lipoatrophy Poly-L-lactic acid is capable of increasing the dermal tissue through stimulating production of collagen contributing to filling volumizing in the treated area Lowe 2006 Vlegger 2014 Unlike other skin fillers that promote volume increase shortly after injection eg HA poly-L-lactic acid exerts its effect over the course of a few weeks This effect is usually visible after two months and noticeable up to two years after treatment Chen 2014 Vlegger 2006 Vlegger 2014
The use of poly-l-lactic acid PLLA has demonstrated significant improvement in multiple facial and body regions Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries Furthermore the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured Therefore this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows
Sculptra Aesthetic is indicated for increasing the volume of depressed areas particularly to correct skin depressions such as in skin creases wrinkles folds scars and for skin aging It is also suitable for large volume corrections of the signs of facial fat loss lipoatrophy Poly-L-lactic acid is capable of increasing the dermal tissue through stimulating production of collagen contributing to filling volumizing in the treated area Lowe 2006 Vlegger 2014 Unlike other skin fillers that promote volume increase shortly after injection eg HA poly-L-lactic acid exerts its effect over the course of a few weeks This effect is usually visible after two months and noticeable up to two years after treatment Chen 2014 Vlegger 2006 Vlegger 2014
The use of poly-l-lactic acid PLLA has demonstrated significant improvement in multiple facial and body regions Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries Furthermore the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured Therefore this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows
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