GALDERMA
30.3.2023 07:01:26 CEST | Business Wire | Press release
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
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
|
New techniques and approaches for the heavy face and the latest data from across the portfolio to be showcased at the congress
As a leader in bringing cutting-edge products to market and in providing the scientific community with individualized treatment approaches, training and business support, Galderma’s extensive presence at AMWC demonstrates its ongoing dedication to advancing dermatology for every skin story.
The focus of the Galderma symposium, titled Aesthetic Lives: Lifting the heavy face will explore the aesthetic journey as a long-term endeavor, using Galderma Holistic Individualized Treatments™ (HIT) to discover the aesthetic lives of patients and the medical professionals who treat them as we shape the future of aesthetics. The event will take place on Thursday, March 30 at 2:00 PM in the Prince Pierre Auditorium.
About Sculptra®
SCULPTRA is the first and original injectable collagen stimulator containing microparticles of unique poly-L-lactic acid (PLLA-SCA) which gradually revitalizes the skin’s structural foundation, providing long-term results for more than two years.3-13 SCULPTRA was first approved in 1999 in Europe, and it is currently available in more than 40 countries globally.
SCULPTRA works to stimulate the skin’s own collagen production9 to provide firm and radiant skin. It is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, and scars, and for signs of skin aging.16
About Alluzience®
Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.17 It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.17 Dosing and treatment intervals depend on assessment of the individual patient’s response.17 The treatment interval should be no more frequent than every three months.17 For more information, please see the Summary of Product Characteristics.17
Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in several European countries.
About Galderma
Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience and Sculptra in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin® in Dermo-cosmetics. For more information, visit www.galderma.com.
References:
1 Fabi S. Poster presented at AMWC 2023.
2 Chadha P. Poster presented at AMWC 2023.
3 FDA. Summary of safety and effectiveness data. 2023
4 Data on file. MA- 54151
5 Asius J et al. Inventors. US patent US 7,731,758 B2,2021
6 Data on file. MA-53568
7 Mest DR, et al. Dermatol Surg. 2006
8 Bohnert K et al. Plast Reconstr Surg. 2019
9 Hexsel D, Dermatol Surg. Letters and Communications. 2020
10 Baron J. Abstract presented at IMCAS 2023. (MA-54104)
11 Goldberg D et al. Dermatol Surg. 2013
12 Narins RS, et al. J Am Acad Dermatol. 2010
13 Brandt FS, et al. Aesthet Surg J. 2011
14 Data on file. MA-48331
15 Hilton et al. Dermatol Surg 2022;48:1198-202
16 Sculptra IFU. 2018.
17 Alluzience Summary of Product Characteristics, 2023
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