Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.
SkinVive is FDA-approved for all Fitzpatrick skin types I to VI (lightest to darkest), addressing a range of skin quality concerns. It is an injectable gel indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
“SkinVive by Juvéderm is a category-creating hyaluronic acid product that leaves skin looking healthier, more glowing and more hydrated,” said Carrie Strom, president, Global Allergan Aesthetics and senior VP, AbbVie. “This unique product is a result of our vast experience in hyaluronic acid science and complements our current collection of hyaluronic acid products, with the Juvéderm collection of fillers and SkinMedica topicals.”
According to Allergan Aesthetics, SkinVive is slated for commercial availability within the next six months, exclusively through licensed physicians and practitioners.
SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation.
The FDA granted approval based on promising clinical results, demonstrating that SkinVive enhances hydration, thereby improving skin smoothness of the cheeks and delivering a lasting radiant glow for up to six months with optimal treatment.
“Skin quality is among the top concerns my patients express when seeking aesthetic treatments. It’s an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance,” said Macrene Alexiades, MD, PhD, dual US-EU board-certified dermatologist, SkinVive by Juvéderm lead investigator and author of the clinical trial published in Dermatologic Surgery.
“One key way to improve skin quality is by enhancing hydration. SkinVive by Juvéderm is truly innovative because it works beneath the skin’s surface to increase skin hydration improving skin quality. I am excited to add this unique offering to my dermatologic treatment regimen for my patients,” added Dr. Alexiades.
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How Does SkinVive (Juvéderm Volite) Work?
SkinVive is known as Juvéderm Volite abroad. It is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant.
Skinvive is supplied in individual treatment syringes with needles for single-patient use, making it convenient and ready for injection. The recommended initial injection volume for optimal improvement in skin smoothness of the cheeks is typically 4 mL. Subsequent maintenance treatments should be administered at a lower dose of 2.7 mL to sustain the desired effect. It is crucial to note that each patient should not exceed a total of 20 mL of SkinVive injectable gel per 60 kg of body mass within a year.
The functioning of SkinVive involves injecting a combination of hyaluronic acid and a small amount of the local anesthetic lidocaine into the facial skin. This formulation promotes the increase of aquaporin, a hydration marker that facilitates the movement of water and glycerol into and out of cells, resulting in improved skin hydration.
Research conducted by Allergan Aesthetics using ex vivo human skin samples and an in-situ study on the volar forearms of healthy volunteers demonstrated that hyaluronic acid (the primary active ingredient in SkinVive) can enhance collagen density in the upper reticular dermis and increase fibrillin-1 expression. Collagen is essential for maintaining skin strength and resistance to mechanical deformation, while fibrillin-1, a glycoprotein, supports the integrity of the dermal elastic fiber network.
Overall, SkinVive injections lead to improvements in the microscopic structural aspects of the skin.
Safety and Efficacy of SkinVive
A randomized, multicenter, evaluator-blind, controlled clinical study was conducted to assess the safety and effectiveness of SkinVive. At the start of the study, 135 participants were randomized and had treatment with SkinVive, while 73 participants were randomized to control.
At the one-month follow-up after the initial treatment, the following significant improvements were observed in various aspects of facial skin:
- Approximately 74.4 percent of participants reported feeling satisfied with the radiance of their facial skin, compared to only 11.1 percent at baseline.
- Around 78.4 percent expressed satisfaction with the hydration of their facial skin, which was a notable increase from the 23.7 percent reported at baseline.
- Approximately 79.2 percent felt refreshed by the appearance of their facial skin (compared to 15.6 percent at baseline).
- 84.0 percent were satisfied with the perceived healthiness of their facial skin (compared to 37.8 percent at baseline).
- Around 80.8 percent reported satisfaction with the appearance of their pores, a substantial improvement from the 29.6 percent reported at baseline.
During the six-month follow-up period, the majority of participants in the treatment group maintained clinically significant improvements in skin smoothness of the cheeks, as indicated by a one-point or higher improvement on the Allergan Cheek Smoothness Scale (ACSS).
The clinical study also showcased the good tolerability of SkinVive, supporting its potential as a long-term treatment option. The common side effects include lumps/bumps, redness, swelling, tenderness, bruising, pain, firmness, discoloration and itching at the injection sites, but most of them went away on their own within 30 days. It is crucial to note that, as with any skin injection procedure, there is a potential risk of infection.
What is the Price of SkinVive?
Allergan Aesthetics did not list the price of SkinVive yet; however, a plastic surgeon in New York City, Dr. David Shafer of the Shafer Clinic, says the price of SkinVive in their clinic will begin at $1,800 per treatment depending on the amount of product needed and the areas being treated.
Other FDA-Approved Skin Treatments
Daxxify is an innovative aesthetic product developed by Revance Therapeutics, an American biotechnology company at the forefront of pioneering advancements in neuromodulators for both aesthetic and therapeutic purposes. In 2022, Daxxify received FDA clearance for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Revance is currently assessing the safety and efficacy of Daxxify for the treatment of forehead lines, lateral canthal lines and upper facial lines.
Another noteworthy development by Revance Therapeutics is their RHA collection (resilient hyaluronic acid filler collection), which includes RHA Redensity, RHA 2, RHA 3 and RHA 4. This collection stands as the first FDA-approved filler specifically designed for injection in areas of the face with dynamic facial movement.