The newly FDA approved Sculptra® label has exciting implications for aesthetic injectors. 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 Sculptra injection techniques
- the option to add lidocaine
- immediate use after reconstitution
Sculptra is already 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 this FDA approved Sculptra Technique?
Sculptra smooths facial wrinkles such as smile lines, known technically as shallow to deep nasolabial fold contour deficiencies.
Sculptra is a collagen biostimulator, meaning it achieves this by stimulating collagen production in the skin. It is the first and only FDA-approved PLLA facial injectable treatment to work this way. Sculptra produces gradual, natural-looking results over an average period of 3 treatments spaced 6 weeks apart.
Sculptra is produced by the world’s largest independent dermatology company Galderma, in operation since 1981 and present in over 100 countries worldwide.
The Game-Changing Sculptra Study Findings
In a 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 at a 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 2 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.”