FDA approves Restylane Lyft as dermal filler for the back of the hands.- Galderma/Nestle.
The FDA has approved Restylane Lyft (hyaluronic acid), from Galderma/Nestle, dermal filler for the correction of age-related volume loss in the back of the hands for patients over the age of 21. 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.
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.
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