New FDA Approval of Galderma’s SCULPTRA Label Means More Choice for Aesthetic Providers
The newly approved SCULPTRA label has exciting implications for clinicians. Swiss pharmaceutical company Galderma has received new FDA approval for an expanded label on injectable poly-L-lactic acid (or PLLA) product SCULPTRA, allowing for:
● Higher dilution
● New injection techniques
● Optional addition of lidocaine
● Immediate use after reconstitution
Sculptra is the first FDA-approved PLLA facial injectable treatment that boosts the patient’s skin collagen production. The new label gives aesthetic providers a more comprehensive range of options for its administration.
What is SCULPTRA?
Known to smooth facial wrinkles such as smile lines, Sculptra is a collagen biostimulator that targets and stimulates collagen production in the skin. It is the first and only FDA-approved PLLA facial injectable treatment with this mechanism of action. Sculptra produces gradual, natural-looking results over an average period of three treatments, spaced three or more weeks
apart.
Sculptra is produced by the world’s largest, independent dermatology company Galderma, in operation since 1981 and now present in over 100 countries worldwide.
The Game-Changing Study Findings
The expanded label comes on the back of a 2020 physiochemical study published in the Journal of Drugs and Dermatology (JDD), which found that vigorous shaking for one minute effectively dissolved the product's excipients and had no impact on the PLLA particles. This is compared to
the previous reconstitution technique, which required two hours ‘standing time’ before use.
Another randomized, evaluator-blinded, parallel-group, the multi-center study found that a higher reconstitution volume including lidocaine “was well tolerated, caused less pain and was comparable to that of the reference group.” This comes with a favorable risk-benefit ratio:
adverse effects were only reported in 3.6% of study participants, and all were low intensity.
What the New FDA Approval Means for Patients
The new label equips aesthetic providers with more options to offer their patients.
The challenges addressed and benefits include:
● the immediate use protocol provides greater convenience by reducing wait times from two hours to mere minutes
● the option to add lidocaine offers decreased pain, improving patient
comfort throughout the treatment
● additional evidence of the treatment’s safety helps boosts patient-provider trust
According to 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.”
Clinicians can access information and training on the new Sculptra label via the Galderma Aesthetic Injector Network (GAIN), which offers education and support to aesthetic dermatology providers who incorporate Sculptra into their practice.
Allie McAllister, NP-C DCNP is the provider and owner of The Atlanta Injector and aesthetic practice in Atlanta, Georgia. She is the co-founder of Cult Aesthetics an Advanced Injector Retreat Style Conference. When not working, she enjoys traveling with her fiancé and French bulldog.