Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area.3
Sculptra is the first and original FDA-approved PLLA collagen stimulator that, when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow, with results lasting up to 2 years.1-5
Sculptra achieved its primary efficacy endpoint of ≥1-grade improvement in cheek wrinkles at rest and its secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years.3*
"The long-standing science, safety and efficacy behind Sculptra makes this FDA approval a meaningful milestone for Galderma. With 95% of patients† still showing improved skin glow two years after treatment when injected into the cheek region,1 we recognize how much of an impact biostimulators can have on the aging face. This new indication allows for Sculptra to pave the way as a leader in the PLLA collagen stimulator category, and we are excited to see what the future holds for this innovative product."
Bill Andriopoulos, PH.D.
U.S. Vice President of Medical Affairs at Galderma
Patients† showed sustained aesthetic improvement in cheek wrinkles throughout the study with 96% showing improvement at 3 months, 94% showing improvement at 1 year and 94% showing improvement at 2 years.1,6‡
"Sculptra is a foundational treatment that helps smooth wrinkles and offers the added benefit of improved skin quality – helping to firm sagging skin for a more radiant and glowing appearance.1-3 My patients will be extremely pleased that they can now receive Sculptra in the broader cheek region to support collagen growth and to make their skin look more refreshed and rejuvenated.3,5,7"
Sabrina Fabi, MD
Double Board-Certified Dermatologist and Dermatologic Cosmetic Surgeon
in California, who Served as an Investigator in Clinical Trials of Sculptra
for Cheek Wrinkle Treatments
This FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, no-treatment controlled, multicenter study to evaluate the effectiveness and safety of Sculptra for correction of cheek wrinkles.
To learn more about Sculptra, visit www.SculptraUSA.com and follow the conversation on Instagram at @SculptraUSA.
*≥1-grade improvement on the Galderma Cheek Wrinkles Scale (GCWS; At rest and Dynamic)
†Patients = clinical trial participants
‡Rating of 'improved' or better on the Global Aesthetic Improvement Scale (GAIS)
About Sculptra®
Sculptra (injectable poly-L-lactic acid (PLLA-SCA)) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.3
Sculptra is an injectable collagen stimulator containing microparticles of poly-L-lactic acid (PLLA-SCA) which help gradually revitalize the skin's structural foundation, smoothing wrinkles and improving overall skin quality to provide natural-looking, long-term results for up to 2 years.1-3,5,7§ Sculptra was first approved for aesthetic use in 2009 in the United States and is currently available in more than 40 countries globally. To learn more about Sculptra products, visit www.SculptraUSA.com.
§Clinical study ended at 96 weeks (2 years)
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 spans 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. For more information, please visit www.galderma.com/us.
To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
[email protected]
+41 76 315 26 50
Jeffrey Smith
Head of U.S. Communications
[email protected]
+1 682 401 8428
IMPORTANT SAFETY INFORMATION
Indication: Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.
Sculptra should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.
Sculptra has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.
The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.
Sculptra is available only through a licensed practitioner. Complete Instructions for Use are available at www.SculptraUSA.com.
References:
- Data on file. 43USSA1812EXT clinical study report. Fort Worth, TX: Galderma Laboratories, L.P. 2022.
- Bohnert K. et al. Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality Dermatol Surg 2019;45:718–724.
- Sculptra. Instructions for Use. Galderma Laboratories, L.P. 2023.
- Bergeret-Galley C. Comparison of Resorbable Soft Tissue Fillers. Aesthetic Surg J 2004; 24:33-46.
- Goldberg D, Guana A, Volk A, Daro- Kaftan EDermatol Surg. 2013;39(6):915-922.
- Data on file. 43USSA1812 Clinical study report. Fort Worth, TX: Galderma Laboratories, L.P., 2022.
- Fitzgerald R, et al. Aesthet Surg J. 2018;38(suppl_1): S13-S17.
