- Sculptra®, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1
- Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour
- Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs
- The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient needs
Zug, Switzerland – December 5, 2025 – Galderma (SIX: GALD), the pure-play dermatology category leader, today 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.1-5 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.6 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.7 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.1-5,8-12
“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.2-5 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 satisfaction3
- 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 again4
- 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 skin2
- 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 treatment5
“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
CHIEF EXECUTIVE OFFICER
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.
This material refers only to the product certified under Regulation (EU) 2017/745 (MDR). Legacy versions of the product remain available. For full product information and the Instructions for Use (IFU), visit: https://www.galderma.com/sites/default/files/2025-12/IFU_Sculptra_MDR.pdf
About Sculptra
Sculptra is the first proven regenerative biostimulator, with a unique poly-L-lactic acid (PLLA-SCA™) formulation, to provide, progressive, and sustained regenerative effect across all three skin layers.1,10-16 Sculptra reverses aging processes in the skin, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.1,10,11,17-19 Sculptra progressively rebuilds the skin’s structural foundation by encouraging the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore volume, firmness, radiance and skin quality, and the look of fullness to wrinkles and folds over time.1-5,10,11,20 Sculptra has been shown to provide visible improvements as early as one month after treatment, with results lasting up to two years.1,4,9,15,20
About Galderma
Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
REFERENCES:
1. Sculptra®. EU Instructions for Use. 2025. Available online. Accessed December 2025.
2. Galderma. Data on File (MA-57540).
3. Nikolis A, et al. A Prospective, Multicenter Trial on the Efficacy and Safety of Poly-L-Lactic Acid for the Treatment of Contour Deformities of the Buttock Regions. J Drugs Dermatol. 2022;21(3):295–303.
4. Beleznay K, et al. Safety and Effectiveness of Poly-L-lactic acid (PLLA-SCA) for the Improvement in Appearance of Cellulite – A Pilot Study. Poster presented at the IMCAS World Congress; February 1-3, 2024; Paris, France.
5. Mazzuco R, et al. Clinical and Histological comparative outcomes after injections of Poly-L-Lactic Acid and Calcium Hydroxyapatite in arms – a split side study. J Cosmet Dermatol. 2022;21(12): 6727–6733.
6. IFOP for NSH – Skin Quality Concerns – September 2019.
7. De la Peña JA, et al. History of gluteal augmentation. Clin Plast Surg. 2006 Jul;33(3):307-19.
8. Galderma. Date on File (MA-60875).
9. Goldberg D, et al. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915–922.
10. Waibel J, et al. Bulk RNA-seq Analysis of Poly-L-Lactic Acid (PLLA-SCA) vs Calcium Hydroxyapatite (CaHA-R) Reveals a Novel, Adipocyte Mediated Regenerative Mechanism of Action Unique to PLLA. Poster presented at ASDS 2024 Annual Meeting; October 17-20, 2024; Orlando, Florida, United States.
11. Waibel J, et al. Gene Analysis of Biostimulators: PLLA-SCA Triggers Regenerative Morphogenesis while CaHA-R Induces Inflammation upon Facial Injection. Poster presented at ASDS 2024; October 17-20, 2024; Orlando, Florida, United States.
12. Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression. J Drugs Dermatol. 2024;23(4):285–288.
13. Galderma. Data on File (MA-46589).
14. Vleggaar D, et al. Consensus recommendations on the use of injectable poly-L-lactic-acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(4 Suppl):s44–s51.
15. Widgegrow J, et al. A randomized, comparative study describing the gene signatures of poly-l-lactic acid (PLLA-SCA) and Calcium Hydroxyapatite (CaHA) in the treatment of nasolabial folds). Poster presented at IMCAS World Congress; February 1-3, 2024. Paris, France.
16. Duracinsky M, et al. Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients. BMC Infect Dis. 2014;14(474).
17. Zhang S and Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018;27(5):729–738.
18. Shuster S, et al. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93(6):639-43.
19. Zarbafian M, et al. The emerging field of regenerative aesthetics—where we are now. Dermatol Surg. 2022;48:101–108.
20. Fabi S, et al. 24-month clinical trial data on effectiveness and safety after correction of cheek wrinkles using a biostimulatory poly-L-lactic acid injectable implant. Poster presented at IMCAS World Congress; January 26-28, 2023; Paris, France.