NCT05608239

Safety and Efficacy of Injectable Poly-L-Lactic Acid for Volume Loss in the Temples Using Dual Plane Injections

Prospective, Single-site, Open Label Study to Assess the Safety and Efficacy of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Volume Loss in the Temples Using Dual Plane Injections

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sadick Research Group · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.

Detailed description

This is a prospective, single-site, open label study to assess the safety and efficacy of injectable Poly-L-Lactic Acid (Sculptra aesthetic) for volume loss in the temples using dual plane injections. Eligible subjects will get up to 3 treatments four weeks apart with poly-L-lactic acid, (Sculptra) in the temples. After the treatments, subjects will return to the research site 1 month and 6 months post last treatment for follow up visits.Eligible subjects will get up to 3 treatment sessions 4 weeks apart with ether Sculptra® Aesthetic or saline following a randomized list. During the study period, subjects will return to the research site for visits at 5 and 6 months post baseline (±7 days).

Conditions

• Lipoatrophy
• Aging

Interventions

Type	Name	Description
DEVICE	Sculptra aesthetic	The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples with total volume of the diluted product as 9 ml (8 ml of sterile water and 1 ml of Lidocaine).

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-07-01
• Completion: 2023-11-01
• First posted: 2022-11-08
• Last updated: 2022-11-08