Galderma has received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds (NLF) or “laugh lines.” Restylane® Refyne was approved for the treatment of moderate to severe facial wrinkles and folds and Restylane Defyne for the treatment of moderate to severe, deep facial wrinkles and folds. Refyne and Defyne have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months.1,2
The FDA approval was based on two pivotal, double-blinded, randomized, active-controlled Phase 3 studies investigating Refyne and Defyne (involving 171 and 162 subjects, respectively) to evaluate their safety and effectiveness. In both studies, Refyne and Defyne met the studies’ endpoints, with both products showing a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patients. Study investigators used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles, with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles. Investigators reported that 79% of Refyne subjects and 77% of Defyne subjects had at least a 1-grade improvement on the WSRS after 6 weeks. Subjects also performed self-assessments (SSA) of wrinkle severity, with most subjects reporting at least a 1-grade improvement in SSA scores with Refyne and with Defyne after 6 weeks.
After initial treatment, injection site responses (redness, swelling, bruising, lump/bump formation, pain/tenderness) were predominantly mild or moderate in intensity, temporary (typically with a duration of one to two weeks).
Restylane Refyne and Restylane Defyne were first approved in Europe in 2010 under the brand name Emervel.
The Restylane line of hyaluronic acid fillers is used to help smooth away wrinkles (Restylane & Restylane Lyft), create fuller and more accentuated lips (Restylane Silk), and add lift and volume to the cheeks (Restylane Lyft).
JUVÉDERM VOLUMA XC injectable gel is now available in the United States. This is a hyaluronic acid filler, available for several years in Europe, intended for deep placement to add volume to the mid-face. JUVÉDERM VOLUMA XC is the first and only filler FDA-approved to instantly add volume to the cheek area. It provides a subtle lift, helping to restore contour and a more youthful profile, for up to 2 years, adding volume to the cheek area.
What else should you know about JUVÉDERM VOLUMA XC?
- First and only Hyaluronic Acid (HA) filler FDA-approved to instantly add volume to the cheek area, resulting in a subtle lift
- Clinically proven to last up to 2 years with optimal treatment.
- After 24 hours, you should be able to resume your normal activities
- Side effects are moderate and generally last 2 to 4 weeks. Common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.
Hyaluronic Acid (HA) is a naturally occurring, hydrating substance found in your skin. As you age, you start to lose HA, which causes the skin to lose structure and volume.
After - 4.8 mL of JUVÉDERM VOLUMA™ XC was injected into the zygomatic arch, anteromedial cheek, and submalar region
Sculptra is a skin filler that works differently from the hyaluronic acid fillers (such as Juvederm, Restylane and Belotero). Sculptra is made from poly-L-lactic acid, which helps to replace lost collagen. Sculptra does not work instantly. Rather, it gives you increasing results over time, as it stimulates your body to generate new collagen. The results of a full treatment course of Sculptra, an average of three injection sessions over a few months, can last more than two years. It helps correct shallow to deep facial wrinkles, and folds. Sculptra is suitable for deep folds between the nose and the mouth (nasolabial folds) also called smile lines, the lines framing your mouth (marionette lines), and chin wrinkles.
See more Scultra Before and After Photos