March 4, 2021
- Updated administration protocol means Sculptra® offers the fastest reconstitution of any injectable poly-L-lactic acid (PLLA) available in Europe
- Updated protocol allows for faster and more convenient administration of Sculptra® with the optional addition of lidocaine to increase patient comfort
- Update is based on new data from physiochemical and clinical studies evaluating the safety and effectiveness of Sculptra®
- Virtual event held with European healthcare professionals to mark re-launch provided additional education and support on new protocol
Lausanne, March 4th, 2021 – Galderma today announced a European re-launch of Sculptra® (injectable poly-L-lactic acid) - a collagen stimulator - with an updated administration protocol. This means that the product is ready for use more quickly following reconstitution, with increased levels of comfort for patients. Sculptra® can now be used immediately following a two-minute reconstitution and with the optional addition of lidocaine for patient comfort. Previously, healthcare professionals had to wait two hours following reconstitution to administer the product. Sculptra® now has the fastest reconstitution protocol of any injectable poly-L-lactic acid (PLLA) available in Europe, representing a significant growth opportunity for Galderma.
“Sculptra® has been my go-to tool for treating skin laxity resulting from aging and collagen loss in my patients’ skin, helping restore a youthful appearance,” said Dr. Christoph Martschin, Dermatologist, Akademikliniken, Department of Dermatology, Stockholm, and a featured speaker at the Sculptra® European re-launch virtual event. “This new reconstitution protocol for Sculptra® represents an exciting benefit as we are able to save valuable clinic time for clinicians while improving overall procedure comfort for our patients.”
Collagen provides structure and support to the skin. With facial aging, the skin’s natural collagen supply may decrease and could lead to skin laxity, wrinkles and roughness as skin quality worsens.1,2 Sculptra® is a collagen stimulator that may help replenish lost collagen by gradually stimulating and increasing an individual’s own natural collagen production, helping restore skin quality and firmness.2-5
The updated protocol is based on new data from physiochemical studies,6 as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study (NCT03780244) evaluating the safety and effectiveness of two different dilutions of Sculptra®. This study demonstrated that treatment immediately following a two-minute reconstitution using the higher reconstitution volume (9 mL including lidocaine) was well tolerated, caused less pain on injection and was comparable to that of the reference group (Sculptra® 5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80). Additionally, the mean change in wrinkle assessment scale (WAS) from baseline (assessed by Blinded Evaluator) was similar in both Sculptra® study groups across 48 weeks and investigator assessed improvement using the Global Aesthetic Improvement Scale (GAIS) was > 90% in both Sculptra® study groups.
As part of this European re-launch and in line with the company’s intensified commitment to Sculptra®, Galderma held a dedicated interactive, virtual event with over 1,000 healthcare professionals to provide additional training and support related to this new administration protocol. The event also facilitated best practice sharing among physicians based on their clinical experiences.
“We are delighted to bring this expanded Sculptra® offering to healthcare professionals in Europe, and yesterday’s launch event was an exciting, well-attended re-introduction to Sculptra® and Galderma’s larger aesthetics portfolio,” said Alexandre Brennan, Global Business Unit Head, Aesthetics. “We continue to build a unique and extensive aesthetics offering at Galderma, and are proud to re-launch Sculptra® in Europe as the foundation of our portfolio alongside a range of complementary treatments to deliver impressive and long-lasting results for healthcare professionals and their patients.”
Sculptra® was first approved in Europe in 1999, in the United States in 2009 and in Brazil in 2004. Sculptra® is now available in more than 40 countries globally, and additional regulatory reviews of applications for Sculptra® in various regions are ongoing.
Sculptra® works to stimulate the skin’s own collagen production and is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, scars and for skin aging. Sculptra® is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).
Sculptra® is an injectable biostimulator containing microparticles of Poly-L-Lactic Acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months. Sculptra® was first approved in 1999 in Europe and it is currently available in more than 40 countries globally. To learn more about Sculptra® products, visit www.galdermaaesthetics.com
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in approximately 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with healthcare professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com
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- Shuster S, Black MM, McVitie E. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93:639-643.
- Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92.
- Stein P et al. J Dermatol Sci 2015;78(1):26–33.9.
- Goldberg D et al. Dermatol Surg 2013;39(6):915–22.
- Vleggaar D et al. J Drugs Dermatol 2014;13 (4 suppl):s29–31.
- Baumann K et al. J Drugs Dermatol. 2020;19(12):1199-1203.