AMWC 2023: Data From Sculptra Cheek Wrinkle and Alluzience Star Studies Reinforce Strength of Galderma’s Broad Aesthetic Portfolio

2023年04月04日 17:22:57

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Galderma will present results from the innovative Sculptra Cheek Wrinkle study, which demonstrate the long-lasting results over a 24-month period of the treatment for cheek wrinkle correction with significant improvements in skin firmness and radiance1
Data from the Alluzience STAR study will also be featured, demonstrating sustained aesthetic improvement in glabellar lines up to month six, high patient satisfaction and a preference of investigators to use a ready-to-use solution over the powder product in 81% of treatment sessions2
Additional posters from across the portfolio will be presented and the company will host a symposium featuring the Galderma Holistic Individualized Treatments (HIT) approach to focus on long-term treatments and lifting the heavy face

ZUG, Switzerland--(BUSINESS WIRE)--Galderma will be presenting the latest data from the Sculptra® (injectable poly-L-lactic acid, PLLA-SCA) Cheek Wrinkle and Alluzience® (abobotulinumtoxinA solution) STAR studies at the 21st Aesthetic & Anti-Aging Medical World (AMWC) Congress, taking place in Monaco, from March 30 to April 1, 2023. Results demonstrate high aesthetic improvement as well as patient and investigator satisfaction for both products, reinforcing the strength of the company’s highly differentiated aesthetic portfolio, and underscoring its commitment to delivering science, innovation, and a premium experience throughout the treatment journey.1,2

Data from the innovative Sculptra Cheek Wrinkle study, a large clinical registration trial in the United States, show the long-lasting effectiveness of the treatment for cheek wrinkle correction over a two-year period.1 Sculptra is the first and original collagen stimulator with the unique PLLA-SCA3,4,5,6,7,8 that addresses the root causes of the skin aging process by stimulating the body’s own collagen production.9 This helps restore the skin’s foundation and structural function, gradually improving the its firmness, increasing skin elasticity and improving skin quality and radiance. Results are natural, progressive and proven to last over two years.10,11,12,13,14

In the study, the response rate at month 12 was significantly higher for Sculptra compared to the control group (71.6% vs 26.1%). At months seven to 12, those treated with Sculptra also had improved dynamic wrinkles, and even greater proportions had improved aesthetic appearance (≥93%), improved radiance, skin tightness, and jawline contour (≥86%). Patient satisfaction was high with ≥92% satisfied with their appearance and agreeing their skin’s natural glow was improved two years after treatment.1

In the 12-month extension study for the Sculptra treated arm, with no additional treatment, response rate remained high with aesthetic improvement rates of ≥94% at months 19-24, supporting maintained effects on wrinkles through two years. Results also demonstrated the safety profile of Sculptra. Sculptra was well tolerated with adverse events mostly mild and transient, and no new treatment-related adverse events reported in the 12-24 month follow-up.1

Galderma will also present the latest data from Alluzience’s first phase IV study, STAR, at AMWC. Approved in Europe in June 2021, Alluzience is Europe’s first ready-to-use (RTU) liquid neuromodulator for the treatment of moderate to severe glabellar lines (GLs - frown lines).

The clinical development program of Alluzience has shown rapid onset of effect, starting on day one, a long duration up to six months and improved psychological well-being after treatment.15 The objective of the STAR study was to assess subject and investigator experience using a RTU versus powder neurotoxin and aesthetic improvement, satisfaction and safety after just one treatment during a six-month follow-up period.2

At month one, almost all (99%) of those treated with Alluzience had aesthetic improvement in GLs at maximum frown, which persisted in ~76% up to month six. At month six, most subjects felt that they looked natural (95%) and refreshed (85%) and were satisfied with their appearance (88%). Results also showed high investigator satisfaction, 100% agreeing that it fulfilled their expectations, was easy to use and learn and required the fewest possible steps for its purpose. In 81% of treatment sessions, investigators preferred using the RTU formulation over powder. In addition, in 97% of treatment sessions, investigators felt that using a RTU solution such as Alluzience resulted in substantially less waste and that this was better for the environment.2

 

“The results from both of these important and unique studies reinforce
not only the strength of our broad aesthetic portfolio – for both patients
and physicians – but also our commitment to exploring innovative
approaches to deliver cutting-edge science as effective treatments.
We’re excited to share these data and more at the AMWC congress
and exchanging with the scientific community”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF RESEARCH & DEVELOPMENT
GALDERMA

 

 

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