GALDERMA RESTYLANE LIDOCAINE

Restylane lidocaine® is a clear injectable gel made of hyaluronic acid, a natural substance that already exists in the body.
Restylane lidocaine is not of animal origin and is free of
animal proteins. An allergy pre-test is not necessary. The lidocaine in Restylane contains 0.3% lidocaine.
The lidocaine in Restylane Lidocaine has been added to reduce the discomfort associated with
treatment.

The lidocaine in Restylane is injected into the skin with an ultra-fine needle to plump up the skin to smooth wrinkles and folds such as wrinkles in the nose at the corners of the mouth (nasolabial folds) or in the lips for patients over 21 years of age for lip enhancement.
Lidocaine was added to Restylane to reduce pain and discomfort during and after the injection. In a clinical study, 60 patients received Restylane® on one side of the face and Restylane lidocaine® on the other. Restylane lidocaine had an effect on pain reduction. At the time of injection, patients rated their pain at approximately 45 on a scale of 0 to 100 for the side of the face treated with Restylane. In comparison, patients rated their pain at approximately 15 on a scale
for the side of the face treated with Restylane lidocaine. Patients reported less pain on the side of the
face treated with Restylane-L up to 60 minutes after treatment.

The effects of Restylane Lidocaine usually last about six months and gradually disappear from the body.
A clinical study was conducted with Restylane lidocaine to evaluate the pain reduction effect up to 60 minutes after injection. This study enrolled 60 patients with moderate to severe nasolabial fold wrinkles. The study included 58 female and 2 male patients; 34 were white, 21 were Hispanic or Latino, 3 were African American, 1 was Asian, and 1 was "other."
In this study, 71.7% of patients experienced less pain after Restylane lidocaine injection than with Restylane alone.
In addition to assessing pain reduction effects, the study evaluated patient satisfaction with Restylane lidocaine treatment. The 60 subjects were asked to rate the level of improvement observed in
their nasolabial folds after injection of Restylane lidocaine.
At day 14 post-injection, 100% had some improvement (improved, much improved and very much improved).