Galderma obtained certification of its Sculptra biostimulator for body indications in the European Union on Dec. 5.
Sculptra was first released as a dermal filler in the EU in 1999, approved by the FDA in 2004, and up until now, in Europe and the United States, it has been known to reduce wrinkles in the face by stimulating the skin’s natural collagen production, gradually creating a fuller and more youthful appearance over time.
Now, under this certification, Sculptra’s clinical use will include four new areas: gluteal area, posterior thighs, décolletage and upper arms. Sculptra can be used across these areas to improve skin quality, including cellulite, according to a Dec. 5 press release. In these new areas, it will also be used to enhance firmness, lift and contouring.
“Sculptra’s new and expanded indications mark an important evolution in how we approach aesthetic medicine, moving from facial rejuvenation to full-body restoration,” said Flavia Radke, MD, a plastic surgeon in Germany. “With its proven ability to improve firmness, volume and skin quality beyond the face, this certification empowers us to treat our patients more holistically, combining science, artistry and confidence in a truly individualized way.”
Prior to its acceptance for the body, Sculptra’s clinical studies showed that 96% reported high satisfaction for buttocks, and in the thighs, 100% of patients noted visual improvements after a year, with 93% reporting reduced sagginess.
For the décolletage area, 13% of patients saw a reduction in wrinkling at one month, and wrinkles decreased in 93% of patients at the nine month mark. Skin firmness and quality also improved in the arms two months after a three-session treatment.
