Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)

Facial Wrinkles Clinical Trial

Official title: A Clinical Histology Study Evaluating Biostimulatory Activity Longevity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Facial Rejuvenation

Status Recruiting

Clinical Trial Summary

The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.

Clinical Trial Description

Sculptra is a formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the investigator's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease of erythema index and pore size. In this study we evaluate the existence of histopathological evidence that can elucidate the observed improvement of skin quality after poly-L-lactic acid injections. Specifically we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to dermal remodeling and epidermal thickness.This is a randomized, controlled, double-blind single-center study. The treatment phase will consist of a baseline visit, visits at 4-week and 8-weeks during which eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the treatment group or saline for the control group into both sides of the face. Seven eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the study treatment group and 3 subjects will receive saline for the control group into both sides of the face. The biopsy portion of the study, a punch biopsy will be collected at 4 timepoints throughout the study: at baseline prior to study treatment one, 4 weeks post study treatment one, 48 hours post study treatment three, and 18 weeks post study treatment. Participation is up to 28 weeks and will attend approximately 6 study visits. The subject participation period includes a screening period of up to 2 weeks, three injections at 4-week intervals, and a follow-up visit at 48 hours and 18 weeks after the last injection. to evaluate the histological effect and the "duration" of repeated subcutaneous injections of poly-L-lactic acid (PLLA) on skin quality. As skin SRG-PLLA-02 quality improvement the histopathological analysis with assess expression of procollagen 1, CD31 (vessels), SMA (myofibroblasts), CD163 (macrophages), CD117 (mast cells), & Elastin. ;

Related Conditions & MeSH terms

• Facial Wrinkles
• Facies
• Nasolabial Fold

• NCT number: NCT04957446
• Study type: Interventional
• Source: Sadick Research Group
• Contact: Michelle Malanga, MPA
• Phone: 2112-772-7242
• Email: mmalanga@sadickdermatology.com
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2021
• Completion date: September 1, 2022