Galderma, the pure-play dermatology category leader, announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU Medical Device Regulation (MDR). This expands Sculptra’s current clinical use on the face, to include four new areas: gluteal area, posterior thighs, décolletage, and upper arms. Sculptra can be used across these areas to address varied treatment goals – from improving skin quality (including the improvement in cellulite appearance), to enhancing firmness, as well as lift, projection, and contouring. Sculptra’s versatility allows practitioners to meet each patient’s unique needs, delivering natural-looking, long-lasting improvements across face and body.
Meeting the moment: evolving patient needs
As aesthetic expectations shift, patients are seeking more holistic treatment approaches that address the body as well as the face. Nine out of ten women report aesthetic concerns beyond the face, including skin laxity, volume loss, and cellulite. The gluteal silhouette, in particular, is a focal point of beauty and confidence, with growing demand for non-surgical treatments that enhance its shape and definition. Sculptra’s regenerative effects on collagen and elastin as well as its ability to restore skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour make it uniquely suited to meet these evolving needs.
“Sculptra’s new and expanded indications mark an important evolution in how we approach aesthetic medicine – moving from facial rejuvenation to full-body restoration. 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.” Flavia Radke, M.D., Plastic Surgeon, Vita Aesthetica, Germany
In studies focused on areas such as the gluteal area, posterior thighs, décolletage, and upper arms, patients treated with Sculptra experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour. Improvements were visible as early as one month after treatment and studies showed that:
- In the buttocks, 84% of patients were rated as having “improved” or more by physicians using the Global Assessment of Improvement Scale at six months and 96% reported high satisfaction
- In the thighs, visible improvements were seen as early as one month after treatment, and, at one year, 100% of patients noted visual improvements, and 93% reported reduced sagginess, with 97% of patients expressing they were satisfied with the appearance of their thighs and 83% indicating they would choose to do it again
- In the décolletage, 13% of patients saw a reduction in wrinkling at Month 1 and wrinkle severity visibly decreased in 93% of patients by Month 9. More than 80% of patients were satisfied with the improved quality (including texture and firmness) of their skin
- In the upper arms, visible improvement in skin firmness and quality was seen just two months after a three-session treatment and patients were satisfied with the treatment
“The certification of Sculptra for body indications in the EU marks an exciting evolution in injectable aesthetics. With these new body indications extending Sculptra’s trusted profile beyond the face, we are empowering practitioners to deliver natural-looking, long-lasting results across broader treatment areas, reinforcing Galderma’s commitment to innovation and holistic patient care.” Flemming Ørnskov, M.D., MPH, CEO Galderma
The broadest aesthetics portfolio backed by science, reinforcing Galderma’s commitment to continuous innovation and regulatory excellence.
The EU MDR certification is part of Galderma’s broader MDR transition strategy, which encompasses its full portfolio of aesthetic injectables, such as its Restylane® hyaluronic acid injectables, and dermatological devices. It confirms that Sculptra meets the highest standards of safety, performance, and quality under the updated regulatory framework. While this milestone supports Sculptra’s certification for body indications, it also reinforces Galderma’s broader commitment to delivering innovative, safe and science-backed solutions across its aesthetics portfolio.
First approved in the EU in 1999, Sculptra pioneered a new approach to volume restoration by stimulating the body’s own collagen production.1,13,14 Over the past 25 years, it has evolved into a versatile treatment that delivers regenerative benefits across all three skin layers, making it the first proven regenerative biostimulator. With its expanded indication, Sculptra brings its trusted efficacy to the body, offering patients and practitioners a new opportunity to achieve holistic, full-body aesthetic care.
