Randomized, Double-Blind, Placebo-Controlled Study of Poly-L-Lactic acid for Treatment of Cellulite in the Lower Extremities

May 2021 | Volume 20 | Issue 5 | Original Article | 529 | Copyright © May 2021


Published online April 23, 2021

Alyssa Swearingen a, Kathleen Medrano a, Georgina Ferzli MDa, Neil Sadick MD FAAD FAACS FACP FACPha, Suleima Arruda MDa,b

aWeill Cornell Medical College Cornell University; Sadick Research Group, New York, NY
bArruda Dermatology, Sao Paolo, Brazil

Abstract
Background: Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications.
Objective: The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women.
Methods: 31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings.
Results: At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred.
Conclusion: Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite.

J Drugs Dermatol. 20(5):529-533. doi:10.36849/JDD.5380

INTRODUCTION

Cellulite is an aesthetic condition associated with distress, dissatisfaction and reduced quality of life in 85% to 98% of post-pubertal women. The etiology of cellulite remains elusive, with various pathophysiological mechanisms being proposed over the years including vascular, inflammatory, hormonal, and structural etiology.1-8 It is often characterized by dimpled skin, described as an orange-peel or mattress texture, particularly in the gluteal-femoral region. This appearance is caused by the herniation of subcutaneous fat lobules through the dermo-subdermal junction.9,10 These alterations arise from the female-specific anatomic characteristics of the lamellar fat layer, which, unlike the male, is composed of large, square-shaped adipose tissue lobes separated by connective septa. Changes in these septa lead to skin traction, which manifests as surface depressions. Weight gain, hormones, and lifestyle can all aggravate the appearance of cellulite, as does the process of aging that results in collagen depletion, loss of dermal support, and compromise of skin quality.11

A plethora of treatment modalities have been utilized for the treatment of cellulite, from topical, to minimally invasive, to surgical procedures. Energy-based devices such as lasers, radiofrequency and acoustic wave therapy have shown promise in reduction of cellulite but several treatment sessions are required and results are often temporary.12 Topical therapies are also considered largely ineffective aside from providing additional hydration to the epidermis.13-16

Subcision is a minimally-invasive modality that has shown efficacy in treating cellulite and involves sectioning the fibrous septa by inserting a needle with a blade in the selected cellulite depressions and releasing the retracted skin.17

PLLA was approved as Sculptra® in 2004 by the Food and Drug Administration (FDA) for the treatment of HIV-associated lipoatrophy, and as Sculptra® Aesthetic in 2009 for the correction of shallow to deep nasolabial folds and other facial