Safety and Effectiveness of Poly-L-Lactic Acid (PLLA-SCA) for Improvement in the Appearance of Cellulite.

BACKGROUND

Cellulite is related to collagen and elastic tissue degeneration in the dermis and hypodermis. Sculptra® poly-L-lactic acid (PLLA-SCA™) is a regenerative injectable, inducing collagen and elastin production to help restore the skin’s inner structure.

OBJECTIVE

This 12-month study was conducted to evaluate the effectiveness and safety of PLLA-SCA for the improvement of the appearance of cellulite in the posterior thighs.

METHODS

Women with grade 2–4 cellulite severity on the Galderma Posterior Thigh Cellulite Scale (GTCS) were injected with PLLA-SCA in the posterior thighs (max 3 vials/thigh) at 1–3 treatment sessions, 4–6 weeks apart. Assessments included improvement in cellulite appearance on the Global Aesthetic Improvement Scale (GAIS), GTCS, skin laxity, subject satisfaction, and adverse events (AEs). The primary endpoint was investigator-assessed GAIS at month 9. Time to return to daily activities after each treatment, and pre-defined injection-site responses were collected in a subject diary.

RESULTS

At month 9, 28/29 subjects (97%) had GAIS improvement on both thighs. Overall improvement rates were high on GAIS (≥93% months 2–12) and GTCS (79–100% months 6–12), with improved skin laxity in all subjects at months 6–12. Most subjects were satisfied with thigh appearance (97%) and reported improved skin sagginess (93%) and firmness (97%) at month 12. No treatment-related AEs occurred, and diary events were mainly tolerable and transient, resolving within 1 to 2 weeks.

CONCLUSION

Treatment with PLLA-SCA progressively improved cellulite appearance, reaching ≥93% at months 9 through 12. GTCS improvement rates and subject satisfaction were high. The treatment was well tolerated. &nbsp.