Changes in reconstitution of PLLA for nasolabial folds did not affect safety

A regimen of poly-L-lactic acid and lidocaine did not compromise safety in the treatment of nasolabial folds, according to findings presented at the American Society for Dermatologic Surgery annual meeting.

Melanie Palm, MD, MBA, medical director at Art of Skin MD in Solana Beach, California, and colleagues evaluated the safety and efficacy of a biostimulatory poly-L-lactic acid (PLLA) injectable implant to correct nasolabial folds after changes in reconstitution and injection procedures compared with the U.S. label.

The researchers analyzed data from a 48-week, randomized, evaluator-masked, multicenter study in which subjects received a single treatment regimen comprised of four injection sessions. PLLA was reconstituted with either 8 mL or 5 mL sterile water for injection, and the 8 mL solution included 1 mL of 2% lidocaine.

A wrinkle assessment scale (WAS) was used to evaluate the primary endpoint of change from baseline of both nasolabial folds at week 48.

Fifty-nine subjects were in the 8 mL group and 21 in the 5 mL group. The subjects were 95% women and had a mean age of 51.5 years.

Both groups had high WAS responder rates, consisting of an improvement of at least one grade from baseline, at week 24 ( 75%) and week 48 ( 67%), which met the primary effectiveness endpoint. Aesthetic improvement was rated as high ( 86%).

Adverse events, mostly mild and transient, were reported by 33% of subjects in the 5 mL group and 12% in the 8 mL group.

“PLLA was effective for treatment of nasolabial folds, and safety was not compromised using a higher reconstitution volume including lidocaine, administered immediately after reconstitution,” the researchers wrote.