FDA approves higher dilution, immediate reconstitution, and more.

A new FDA-approved label for Sculptra® (injectable poly-L-lactic acid (PLLA)) from Galderma includes higher dilution, the addition of immediate use reconstitution, new injection techniques, and the optional addition of lidocaine. Sculptra is the first and only FDA-approved PLLA facial injectable treatment, used to stimulate the skin’s own collagen production to smooth facial wrinkles, such as smile lines.

“I’ve been using Sculptra with my patients for over 10 years and it is my go-to product for collagen stimulation, with natural-looking, long-lasting results that address a number of underlying aging concerns, such as facial wrinkles and volume loss,” says Melanie Palm, MD. “Aesthetic injectors will find that the higher reconstitution volume with optional lidocaine can help increase patient comfort, and the immediate use protocol provides greater convenience.” 

The new label approval is based on data from physiochemical studies, as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study evaluating the safety and effectiveness of two different dilutions of Sculptra. In the study, treatment immediately following reconstitution with a higher reconstitution volume (9mL including lidocaine) was well tolerated, caused less pain, and was comparable to that of the reference group (Sculptra 5mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80) as observed by both Investigator and Blinded Evaluators.

Sculptra is typically administered via three treatments spaced at least three weeks apart, with results appearing gradually. In a clinical study, 100 percent of patients still showed improvement in the appearance of wrinkles up to two years after last treatment according to investigator evaluation.

Galderma will use its Galderma Aesthetic Injector Network (GAIN) training and education platform to educate injectors bout the new label, train on injection technique, and share best practices for incorporating Sculptra into their aesthetic offering.