FDA Approves Restylane Lyft

Hands don't lie…until today. The US Food and Drug Administration has approved the hyaluronic acid (HA) dermal filler Restylane Lyft for the correction of age-related volume loss in the back of the hands for patients over the age of 21, according to Nestlé Skin Health, which notes that Restylane Lyft is the first and only HA injectable gel to be FDA-approved for restoring fullness to the back of the hands, providing more youthful-looking skin. It is also the first-ever HA dermal filler to receive FDA approval for an area other than the face.


“As we age, we lose volume in the back of the hands, causing the appearance of tendons, wrinkles and veins to become more pronounced,” stated Dr. Ellen Marmur, a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft in the hands. “Many of my patients start to notice their youthful-looking faces aren't matching their aging hands, and ask me what they can do about it. I am now pleased to be able to offer them Restylane Lyft, an injectable HA treatment that many are familiar with since it has been on the market for over 10 years for facial wrinkles.”


“This new indication demonstrates Nestle Skin Health's mission to deliver a stream of innovative aesthetic solutions that help bring new patients into the market,” said Alisa Lask, GM/VP-US aesthetic business unit at Nestlé Skin Health. “Restylane Lyft is now the first and only dermal filler with 3 FDA-approved treatment areas – the midface/cheek area, nasolabial folds, and now the back of the hands.”


This FDA approval was based on a multi-center, randomized, evaluator-blinded, split-hand study investigating safety and efficacy of Restylane Lyft for use in the dorsal (back side) of the hands. Eighty nine patients age 22 and over were enrolled in the trial. The study met its primary endpoint, showing a clinically meaningful improvement in the correction of volume deficits of treated hands for up to six months. Restylane Lyft was shown to be both safe and well-tolerated, for the correction of volume deficit in the dorsal (back side) hand. After initial treatment, injection site responses (swelling, tenderness, redness, bruising, pain, itching, impaired hand function) were predominantly mild in intensity and temporary, according to the company.


“As demonstrated in this first-in-class clinical trial, Restylane Lyft offers a safe and effective HA treatment option for restoring volume to the hands and delivering natural-looking results,” added Dr. David Bank, New York dermatologist and clinical investigator for Restylane Lyft in the hands. “This new treatment allows me to address the 65% of women over the age of 35 that believe their hands make them look older than their age.”


Hyaluronic acid is a natural occurring substance in the skin that helps provide fullness and elasticity. It diminishes as we age, and causes the skin to lose volume, while increasing the chances for wrinkles to appear. 


With over 30 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the broadest portfolio of dermal fillers in the US. The portfolio of products help to smooth facial wrinkles and folds, such as smile lines (Restylane-L, Restylane Refyne, Restylane Defyne and Restylane Lyft with Lidocaine), create fuller and more accentuated lips (Restylane Silk and Restylane-L), and add lift and volume to the cheeks and the back of the hands (Restylane Lyft with Lidocaine). 


To learn more about the Restylane family of products, visit www.RestylaneUSA.com. 
Nestlé Skin Health's mission is to enhance quality of life by delivering science-based solutions for the health of skin, hair and nails. As one of the category's leading companies, Nestlé Skin Health conducts ground-breaking product research to provide both the healthcare community and the consumer with an ongoing progression of innovative technologies and products to protect, serve and enhance skin health.