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

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.