NCT06337747

Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline

A Prospective, Randomized-controlled Trial Comparing Superficial Injections With Poly-L-Lactic Acid in the Temporal Fossa Versus Extended Temporal Fossa + Hairline

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Erevna Innovations Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 367.5 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 (e.g., 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.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Traditional technique	Subjects randomized to the traditional technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region.
DEVICE	Experimental technique	Subjects randomized to the extended technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region, as well as 2cc (per side, per treatment) in the posterior (i.e., behind the hairline) temporal region.

Timeline

• Start date: 2023-05-19
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2024-03-29
• Last updated: 2024-08-05

Locations

1 site across 1 country: Canada