Scottsdale, Ariz. —The Food and Drug Administration has approved the use of the facial filler Restylane (hyaluronic acid, Medicis) for lip augmentation, GlobeNewswire reports.
Restylane was approved in 2003 to treat moderate-to-severe facial wrinkles. The new label will now include an indication for submucosal implantation for lip augmentation in patients age 21 and older. The package insert also will include the new indication, along with clinical trial results.
A randomized, multicenter study enrolled 180 patients to evaluate Restylane’s safety and effectiveness for lip augmentation in the upper and lower lip. Patients randomized to Restylane treatment at the start of the study were re-treated at six months, while patients randomized to no treatment received their first Restylane treatment at six months. Safety was measured by adverse events reported throughout the study and patient diaries kept for two weeks after treatment.
According to the company, Restylane was well-tolerated and highly effective for lip augmentation for up to six months. Adverse events — none considered serious — included pain, swelling, tenderness, bruising and erythema.
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