Pharmaceutical company Galderma has announced the certification of Sculptra for body indications in the European Union (EU).
The company shares that this certification under the EU Medical Device Regulation (MDR) expands Sculptra’s current clinical use on the face, to include the gluteal area, posterior thighs, décolletage and upper arms. Following research, the company reported strong outcomes across treatment areas.
In the thighs, patients showed visible improvement, with 93% of the 29 patients in the study reporting reduced sagginess. In the décolletage, 13% of the 30 patients involved saw a reduction in wrinkling by the first month, increasing to 93% with visibly decreased wrinkle severity by the ninth month.
For the upper arms, the five participants involved saw improvements in skin firmness and overall quality two months after completing a three-session treatment. In the buttocks, 84% of the 30 patients were rated as having “improved” or more by physicians using the Global Assessment of the five participants involved Scale at six months and 96% reported high satisfaction.
Flemming Ørnskov, CEO at Galderma, said, “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.”