Galderma’s injectable biostimulator receives regulatory approval for expanded use in the gluteal area, thighs, décolletage, and upper arms

Galderma has received EU Medical Device Regulation (MDR) certification for the use of Sculptra® in body applications, marking an expansion of its current facial indications. The updated certification now includes treatment of the gluteal region, posterior thighs, décolletage, and upper arms within the European Union.

Sculptra, based on poly-L-lactic acid (PLLA), is known for stimulating collagen production to gradually restore volume and improve skin quality. This expanded indication allows clinicians to use the product across the face and body for a broader range of aesthetic goals, including improving firmness, reducing the appearance of cellulite, and enhancing projection and contour.

Clinical Data Supporting the Expanded Use

Clinical studies referenced by Galderma indicate progressive improvements in several treatment areas:

  • Gluteal area: At six months post-treatment, 84% of patients were rated by physicians as “improved” or better using the Global Assessment of Improvement Scale, with 96% reporting high satisfaction.
  • Posterior thighs: Visual improvements were observed in all patients at one year, with 93% noting reduced sagging and 83% stating they would choose to repeat the treatment.
  • Décolletage: A reduction in wrinkle severity was observed in over 90% of patients by nine months, with 80% expressing satisfaction with skin texture and firmness.
  • Upper arms: Improvements in skin firmness were seen two months after a three-session protocol, with high patient satisfaction reported.

Regulatory Context

The certification under EU MDR forms part of Galderma’s transition strategy for its full range of aesthetic injectables and devices. It confirms compliance with updated regulatory standards for safety, performance, and quality.

Originally approved in the EU in 1999 for facial volume restoration, Sculptra was among the first injectable treatments designed to stimulate endogenous collagen production. The product’s mechanism of action allows for gradual improvement in volume, skin texture, and elasticity, contributing to a regenerative approach to aesthetic care.

Shifting Demand Toward Full-Body Aesthetics

According to data cited by Galderma, a growing number of patients are seeking non-surgical treatments to address concerns beyond the face. Common areas of interest include skin laxity, volume loss, and cellulite—particularly in the buttocks and thighs. Sculptra’s expanded indication aligns with this shift, offering an injectable option for practitioners aiming to deliver body-focused rejuvenation protocols.

For full prescribing information and usage instructions, visit:
IFU_Sculptra_MDR.pdf