Restylane Lyft Now FDA-Approved for Hands

Monday, May 21, 2018 | FDA Approval/Clearance , Fillers & Injectables , Product Launches and Updates


The US Food and Drug Administration has approved Restylane Lyft for use on the dorsal hands of people older then 21, making it the first hyaluronic acid (HA) injectable gel approved for this use.

Radiesse (Calcium Hydroxylapatite) is also approved for the correction of lost volume in hands.

“As we age, we lose volume in the back of the hands, causing the appearance of tendons, wrinkles and veins to become more pronounced,” says Ellen Marmur, MD a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft in the hands, in a news release. “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.”

The FDA nod was based on a multi-center, randomized, evaluator-blinded, split-hand study investigating safety and efficacy of Restylane Lyft for use in the dorsal of the hands. Eighty nine patients age 22 and older 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.

“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,” says Alisa Lask, General Manager and Vice President, U.S. Aesthetic Business Unit at Nestlé Skin Health.

 

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