Galderma Receives FDA Approval for New Sculptra Label, Offering More Options to Aesthetic Partners

Posted By American Med Spa Association, Monday, December 13, 2021

Galderma announced today the new label for Sculptra (injectable poly-L-lactic acid (PLLA)), the first and only FDA-approved PLLA facial injectable treatment that helps stimulate the skin's own collagen production, to smooth facial wrinkles, such as smile lines. The new label approved by the U.S. Food and Drug Administration (FDA) includes higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine. These changes provide aesthetic injectors with even more options to administer Sculptra safely and effectively.

"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," said Dr. 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."

Sculptra delivers gradual, natural-looking results over an average of 3 treatments spaced at least 3 weeks apart. In a clinical study, 100% of patients still showed improvement in the appearance of wrinkles up to 2 years after last treatment according to investigator evaluation.

The new label approval is based on new 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. This study demonstrated that treatment immediately following reconstitution with a higher reconstitution volume (9 mL including lidocaine) was well tolerated, caused less pain and was comparable to that of the reference group (Sculptra 5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80) as observed by both Investigator and Blinded Evaluators.

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