A Prospective, Multicenter Trial on the Efficacy and Safety of Poly-L-Lactic Acid for the Treatment of Contour Deformities of the Buttock Regions
March 2022 | Volume 21 | Issue 3 | Original Article | 295 | Copyright © March 2022
Published online February 28, 2022
Andreas Nikolis MD PhD FRCSC,a Kaitlyn M. Enright MSc,a Luiz Eduardo Avelar MD,b Sean Rice MD MSc FRCSC,c Hani Sinno MD CM MEng FRCSC FACS,d Demetrios Rizis MD FRCSC,d Sebastian Cotofana MD PhDe
aErevna Innovations Inc., Clinical Research Unit, Westmount, Quebec, Canada
bClinica Domani, Lourdes, Belo Horizonte, Brazil
cRice Cosmetic Surgery, Toronto, Ontario, Canada
dVictoria Park Medispa, Montreal, Quebec, Canada
eMayo Clinic College of Medicine and Science, Rochester, MN
Abstract
Background: There is a significant emphasis on minimally invasive whole-body rejuvenation throughout the world. Recently, gluteal aesthetics have become an increasingly common patient concern. Although the application of poly-L-lactic acid (PLLA) to the face is already well known, there are relatively fewer publications on its use in other corporeal regions. This study aims to extend previous findings by evaluating the efficacy and safety of PLLA in the treatment of contour (including lifting) deformities of the buttock region.
Methods: This was a prospective, multicenter (3 sites), single cohort, open-label clinical trial. Thirty female subjects were treated with PLLA in the bilateral buttocks, with three treatment sessions, each spaced one month apart and followed for six months after completion of the treatment regimen. At each visit, various safety and clinical efficacy parameters were collected, these included: Global Assessment of Improvement Scale (GAIS), subject satisfaction, skin hydration, elasticity, scaliness, roughness, and 3-dimensional imagery.
Results: Six months following the last treatment, 84.00% of patients were rated as having “improved” or more on the physician assessed GAIS, accompanied by a 96.00% patient satisfaction rate. Approximately three vials of PLLA, per buttock and treatment were used. There were no serious adverse events throughout the duration of the trial, nor adverse events related to the investigational device. The most common subject-reported adverse events included pain during treatment (Mean: 70.97%) and bruising (Mean: 28.80%). Objective improvements were persistent after treatment in measurements of skin elasticity (improved 63.5% - 82.5% from weeks 16-32), hydration (increased ~11 Corneometer® units by week 16), roughness (decreased 36.95% at week 32), and scaliness (desquamation; decreased 60.41% at week 32).
Conclusions: PLLA is safe and effective for the indication of buttock contouring and improving parameters of skin health. PLLA can provide long-lasting effects with a high level of patient and physician satisfaction.
J Drugs Dermatol. 2022;21(3):295-303. doi:10.36849/JDD.5942
INTRODUCTION
In addition to providing temporary soft tissue augmentation, non-invasive treatment of volume loss is one of the most common aesthetic treatments performed worldwide. Hyaluronic acid (HA) fillers are the treatment of choice for re-volumizing areas of the face. Recently, HA fillers have also been considered in the treatment of volume loss in the gluteal regions. However, this treatment method is limited by the cost of the HA product in relation to the large quantity required (ie, 200-400 mL).1 The small volumes contained within each syringe of HA filler (eg, 1 mL) make this treatment prohibitively expensive for many patients. Perhaps for these reasons, there is little evidence in support of the use of HA for gluteal augmentation.1 As the popularity of gluteal augmentation increases, clinicians are under greater demands to explore new techniques to fulfill patient expectations. Patients expect treatment options that are safe, effective, and have minimal downtime. Currently, three of the most common procedures available for buttock rejuvenation are: 1) permanent implants; 2) autologous fat transfer; and 3) injection of resorbable fillers (eg, HA). Compared to HA fillers, poly-L-lactic acid (PLLA; Sculptra® Northbridge, NJ) has the added benefit of being a biostimulator. In addition to providing immediate soft tissue augmentation through volumization, the product also offers long-term dermal remodeling. This secondary effect contributes to the long duration of PLLA’s benefits.
