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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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).
Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area
at least one degree of improvement in the temporal area volume using the Galderma Temple Volume Deficit Scale (Moradi et al Dermatol Surg. 2020 Sep;46(9): 1148-1154) and GAIS at the last follow up as compared to baseline.
Time frame: 16 weeks
Improvement of facial skin laxity
Improvement of facial skin laxity will be defined as at least 1 point of improvement in the facial area using the 10-point facial laxity rating scale (Silva Hector, Dermatol Surg.2016 Dec;42(12):1370-1379) from baseline throughout week 36.
Time frame: 16 weeks
Adverse events
Safety will be assessed throughout the study by monitoring adverse events clinically and by Ultrasound imaging.
Time frame: 16 weeks
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