Blogs

Galderma Receives FDA Approval for New Sculptra Label, Offering More Options to Aesthetic Partners

By Aesthetic Multispecialty Society posted Jan 19, 2022 10:27 AM

  

Galderma announced that the new label for SCULPTRA® (injectable poly-L-lactic acid (PLLA)), the first and only FDA-approved PLLA facial injectable treatment that helps stimulate the skin’s own collagen production, to smooth facial wrinkles, such as smile lines.1,2 The new label approved by the U.S. Food and Drug Administration (FDA) includes higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine. These changes provide aesthetic injectors with even more options to administer SCULPTRA safely and effectively.

“I’ve been using SCULPTRA with my patients for over 10 years and it is my go-to product for collagen stimulation, with natural-looking, long-lasting results that address a number of underlying aging concerns, such as facial wrinkles and volume loss,” said Dr. Melanie Palm, MD. “Aesthetic injectors will find that the higher reconstitution volume with optional lidocaine can help increase patient comfort, and the immediate use protocol provides greater convenience.”

SCULPTRA delivers gradual, natural-looking results over an average of 3 treatments spaced at least 3 weeks apart.1-3 In a clinical study, 100% of patients still showed improvement in the appearance of wrinkles up to 2 years after last treatment according to investigator evaluation.1*

The new label approval is based on new data from physiochemical studies,4 as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study6 evaluating the safety and effectiveness of two different dilutions of SCULPTRA. This study demonstrated that treatment immediately following reconstitution with a higher reconstitution volume (9 mL including lidocaine) was well tolerated, caused less pain and was comparable to that of the reference group (SCULPTRA5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80) as observed by both Investigator and Blinded Evaluators.1

“Galderma is committed to driving innovation in aesthetics, and the new label for SCULPTRA is just one example of how we continue to invest in our portfolio to ensure our healthcare partners have the products they need. SCULPTRA is an important part of Galderma’s collection of aesthetic treatments in the U.S., and this new label will allow us to improve the overall injector and patient experience,” said Diane Gomez-Thinnes, Head of Galderma U.S.  “Interest in biostimulators is growing, and we are committed to continuing our legacy of training and education, focused on safety and outcomes as a part of our overall commitment to the aesthetic industry.”

Through the Galderma Aesthetic Injector Network (GAIN) training and education platform, aesthetic partners will learn about the new label, train on injection technique, and share best practices for incorporating SCULPTRA into their aesthetic offering.

About SCULPTRA®
SCULPTRAworks to help stimulate the skin’s own collagen production and is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.1,5

SCULPTRA is an injectable biostimulator containing microparticles of Poly-L-Lactic Acid (PLLA) which helps gradually revitalize the skin’s structural foundation, providing natural-looking, long-term results for up to 2 years*.1-3 SCULPTRAwas 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.sculptraaesthetic.com.

About Galderma

Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners 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/us.
 

IMPORTANT SAFETY INFORMATION

IndicationSculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies 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.sculptraaesthetic.com.

*Clinical study ended at 96 weeks (2 years)

References:

  1. Sculptra injectable poly-L-lactic acid. Instructions for Use. Galderma Laboratories. 2021.
  2. Stein P, Vitavska O, Kind P, Hoppe W, Wieczorek H, Schürer NY. The biological basis for poly-L-lactic acid-induced augmentation. J Dermatol Sci. 2015;78:26-33.
  3. Brandt FS, et al. Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles. Aesthet Surg J. 2011 Jul;31(5):521-8.
  4. Baumann K et al. J Drugs Dermatol. 2020;19(12):1199-1203.
  5. Goldberg D, Guana A, Volk A, Daro- Kaftan E. Dermatol Surg. 2013;39(6):915-922.
  6. Data on file. 43USSA1705ext clinical study report. Fort Worth, TX: Galderma Laboratories, L.P. 2021.

SOURCE Galderma

 
0 comments
1 view

Permalink