Key takeaways on biostimulators for body use
- Galderma’s Sculptra gains EU MDR certification for body indications including gluteal area, thighs, décolletage, and upper arms.
- Addresses growing demand for holistic treatments beyond the face, driven by trends such as weight-loss skin changes and menopause.
- Clinical studies show progressive improvements in skin quality, firmness, lift, and contour, with high patient satisfaction.
Galderma’s regenerative biostimulator, Sculptra, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include the gluteal area, posterior thighs, décolletage, and upper arms.
Sculptra’s EU certification: what it means for beauty industry
The product has been in the spotlight over the past year due to its proven benefits and popularity among cosmetic dermatologists, particularly for patients who have lost significant amounts of weight using GLP-1 receptor drugs.
Studies investigating the efficacy of Sculptra beyond the face show patients experienced progressive improvements in skin quality (including the appearance of cellulite), firmness, lift, projection, and contour.
Galderma, the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its MDR approval. 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 cellulite appearance) to enhancing firmness, 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.
“Shifting aesthetic expectations”
Galderma said that aesthetic expectations are shifting, and 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,” shared the business. “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 cellulite appearance), firmness, lift, projection, and contour, make it uniquely suited to meet these evolving needs.
In studies focused on areas such as the gluteal region, posterior thighs, décolletage, and upper arms, patients treated with Sculptra experienced progressive improvements in skin quality, firmness, lift, projection, and contour. Improvements were visible as early as one month after treatment.
Skin laxity, volume loss and cellulite
“Our decision to expand Sculptra’s current clinical application for the face to include the gluteal area, posterior thighs, décolletage, and upper arms was based on demands we were hearing from our aesthetic practitioner partners that patients were increasingly seeking a more holistic approach to treatment across the body as well as the face,” said Gerry Muhle, Senior Vice President and Head of Global Product Strategy, Galderma. “This was supported by consumer research data, such as one report showing that nine out of ten women experience aesthetic concerns beyond the face, including skin laxity, volume loss, and cellulite.”
He added that Galderma also understood that Sculptra’s regenerative effects across all three layers of the skin and its ability to enhance skin quality, firmness, lift, projection, and contouring would make it uniquely suited to meet this growing demand.
“Treatment goals can include tightening skin in the upper arms, smoothing sleep creases in the décolletage, enhancing the shape and projection of the buttocks, or reducing the appearance of cellulite on the back of the thighs,” explained Muhle. “Sculptra is also proving to be very relevant in addressing emerging trends and areas of need, such as the unexpected changes to the skin following medication-driven weight loss and supporting women’s skin health during the menopause transition.”
For body use, the product typically needs to be distributed over larger areas, which requires higher dilution and around three spaced-out treatment sessions to allow progressive collagen stimulation.
