ZUG, SWITZERLAND -- This year marks the 25th anniversary of the approval of Sculptra®, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation. [1-5,10-16]Sculptra works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance, and has been a cornerstone of Galderma’s broad portfolio of proven aesthetic treatments.[17,18] During its 25 years on the market, healthcare professionals have treated millions of patients with Sculptra, with distribution in over 40 countries and regions worldwide.[10,12,19,20]

Pioneer in regenerative aesthetics: Working with the natural processes of the skin

Regenerative aesthetics is an emerging and fast-growing trend in the field.[21,22] It focuses on revitalizing the skin by engaging the body’s own healing mechanisms, working across three layers of the skin to restore and rejuvenate from within and address patient concerns such as volume loss, skin laxity, and structural support loss.[1,13,18,23-26]

Recent gene expression data from a head-to-head study presented at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting showed that Sculptra stimulated more components of the extracellular matrix, including collagen and elastin, while inducing less inflammation, when compared with another biostimulator.[6] Sculptra stimulated 16 pathways related to tissue remodeling and four related to collagen formation, compared to 10 and three, respectively, for the comparator biostimulator.[6]

Additional data presented at the ASDS 2024 Annual Meeting demonstrate Sculptra’s potential positive effect on adipocyte modulation, which might explain its clinical benefits in skin quality such as increased skin glow, improved facial fat function and structure, and reduced signs of facial aging.7 The data showed that treatment with Sculptra resulted in upregulation of 13 genes associated with anti-inflammatory effects and adipocyte modulation.[7]

This was reinforced by two new studies published this year in the Journal of Drugs in Dermatology, which provided supportive as well as deeper insights into the regenerative effects of Sculptra.[5,8] This includes results showing that Sculptra significantly reduced the severity of moderate or severe cheek wrinkles while improving skin quality, with results lasting across the 12-month study period.8 The responder rate was significantly higher for Sculptra versus the no-treatment control at seven months (66.2% and 38.6%), nine months (70.6% and 31.1%) and 12 months (71.6% and 26.1%).[8] Sculptra maintained high patient satisfaction, with over 84% of patients reporting natural-looking results and expressing interest in repeat treatments to correct cheek wrinkles.[8]

Sculptra’s PLLA-SCA™ formulation ensures comprehensive results that improve the skin’s underlying structure, as well as surface appearance.1,13,23-25 By remodeling components of the extracellular matrix, such as elastin and collagen, Sculptra can restore youthful volume through its regenerative properties.2,6,7,27-28

“Sculptra has fundamentally changed the landscape of facial rejuvenation and has had a significant impact on my practice. Sculptra helps to restore patients’ youthful appearance and improve skin quality, while looking and feeling natural - and my patients' satisfaction is evident in their continued attendance at yearly maintenance sessions. This, coupled with the extensive body of evidence on Sculptra’s efficacy and safety, positions Sculptra as a leading choice for practitioners.” ALESSANDRA HADDAD, M.D., PH.D. AFFILIATE PROFESSOR FEDERAL UNIVERSITY OF SAO PAULO BRAZIL

Celebrating 25 years of scientific progress with Sculptra

Sculptra was first launched and approved in the European Union as a volume replenishment treatment in 1999 to correct the facial wasting experienced by AIDS patients.28 A transformative treatment, Sculptra helped reverse the gaunt appearance associated with this disease by stimulating the skin’s natural collagen and elastin production, restoring facial vitality and youthful volume.[6,7,28,29]

Over the years, through Galderma’s continued research into Sculptra’s unique scientific dermatological potential with PLLA-SCA™, it has evolved into a versatile treatment with a range of applications beyond volumization, which can include skin firmness, structural support, radiance, and overall skin quality, with results lasting for over two years.[2,17,29,30]

Recent research shows that, in addition to collagen, Sculptra’s PLLA-SCA™ formulation also has a stimulatory effect on key components of the extracellular matrix, such as elastin, proteoglycans and multi-adhesive glycoproteins, and agents which activate the remodeling of adipose (fat) tissue, making it the first proven regenerative biostimulator.[1-7,24,28] These properties open exciting new possibilities to meet emerging patient needs, such as addressing facial alterations associated with significant or rapid weight loss.[29]

“Sculptra is testament to our commitment to innovation. With over 50 publications and 10,000 patients in clinical studies to date, its safety profile and efficacy are unmatched. We’re excited that even after 25 years, we’re uncovering new information about Sculptra’s regenerative properties, allowing us to explore new possibilities to help patients have better outcomes in their quest for natural, long-lasting rejuvenation.” PROF. ALAN WIDGEROW, MBBCH; MMED; FCS; FACS CHIEF SCIENTIFIC OFFICER, HEAD OF SKIN SCIENCE CENTER FOR INNOVATION, HEAD OF ALASTIN INNOVATION

GALDERMA