Safety and Effectiveness of Two Reconstitution Volumes of Poly-L-Lactic Acid for Correction of Décolletage Wrinkles

June 2026 | Volume 25 | Issue 6 | 553 | Copyright © June 2026


Published online May 30, 2026

John Joseph MDa, Melanie D. Palm MD MBAb, Daniel Bråsäter PhDc, Charlotta Wolgast MScc, Felipe Weinberg MDd, Inna Prygova MDc

aAmalfi-Bio Corporation, Encino, CA
bArt of Skin MD, Solana Beach, CA
cGalderma, Uppsala, Sweden
dGalderma, Dallas, TX

Abstract
Background: Aesthetic patients are increasingly aware of the contrast between rejuvenated facial skin and untreated aging skin of the décolletage, and frequently request cosmetic enhancement of this area. Poly-L-lactic acid (Sculptra®, Galderma; PLLA-SCA) is a regenerative biostimulator that stimulates collagen and elastin production to help regenerate the skin’s inner structure.
Objective: This 9-month, open-label study investigated the effectiveness and safety of correcting décolletage wrinkles with PLLA-SCA using 2 reconstitution volumes.
Method: Women with moderate/severe wrinkles on the Galderma Décolletage Scale (GDS) were randomized 1:1 to receive PLLA-SCA reconstituted with 8 mL or 17 mL sterile water for injection, plus 1 mL 2% lidocaine (up to 4 treatments, 1 month apart). Assessments included GDS, Global Aesthetic Improvement Scale (GAIS), subject satisfaction, skin quality, and adverse events (AEs).
Results: Of 30 randomized subjects, the majority (8 mL: 93.8%; 17 mL: 78.6%) showed a ≥1-point improvement on investigator-assessed GDS at month 9 (primary endpoint), with ≥93% improved also at month 6. GAIS improvement was also great (>90% of subjects) across both groups at months 6 and 9. In both groups, >90% of subjects reported satisfaction with the appearance of their wrinkles by month 3, and this satisfaction was sustained throughout the study. The majority (>80%) of subjects were satisfied with the texture, smoothness, and radiance of their skin at months 6 and 9. One AE was judged as treatment-related; no AEs were serious or led to discontinuation.
Conclusion: Treatment of the décolletage area with PLLA-SCA was effective and well tolerated with both reconstitution volumes, with high subject satisfaction.

INTRODUCTION

Sculptra® poly-L-lactic acid (PLLA-SCA, Galderma) is a regenerative biostimulator containing microparticles of PLLA, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family.1 PLLA-SCA works as a regenerative biostimulator to gradually build collagen and elastin fibers over time, remodel the extracellular matrix, and potentially have effects on adipose tissue in the injected area to help regenerate and restore the skin's inner structure and give the appearance of fuller and more youthful-looking skin.2-9 In the United States (US), PLLA-SCA is approved for correction of nasolabial fold contour deficiencies and fine lines and wrinkles in the cheek region using reconstitution volumes of 5 mL or 8 mL sterile water for injection (SWFI) with the optional addition of 1 mL 2% lidocaine.10

As aesthetic patients achieve a younger appearance through facial rejuvenation, they are often left with an abrupt contrast between their facial and non-facial (body) skin, such as the chest décolletage, and therefore frequently request cosmetic enhancement of this area.11 Initial clinical trials and other clinical reports suggest that treatment of wrinkles with PLLA-SCA in the décolletage area is effective and well tolerated, with satisfactory aesthetic outcomes.12-15

Since the initial approval of PLLA-SCA in 1999 and 2004 in the European Union and the US, respectively, the amount of SWFI used to reconstitute PLLA-SCA has gradually increased. Based on medical literature and physician experience, practitioners have reported improved clinical outcomes with increased reconstitution volumes up to 2 times larger than the volume recommended by the manufacturer, usually in combination with anesthetic solutions such as lidocaine 2%.6,16 There is also data that shows that an increased reconstitution volume helps to reduce the frequency of nodules and papules.11,17