Recent clinical data demonstrated that at 18 months after initial treatment of Restylane®, at least 95% of patientes who received a repeat injection had at least a 1 grade of improvement over baseline on the Wrinkle Severity Rating Scale (WSRS).
Restylane® is the only hyaluronic acid dermal filler whos FDA-approved label includes duration data up to 18 months.
Study Description
The duration of Restylane® effectriveness was demonstrated in a randomized, evaluator-blinded study of 75 patients at three U.S. centers. The study used a bilateral (split-face) comparison design. Patients receivd treatment in both nasolabial folds at baseline, but were randomized for retreatmetn in one nasolabial fold at 4.5 months, and retreated in the other side at 9 months. Teh primary effectiveness endpoint was the number of patients with at least one grade improvements in the WSRS, a five-point scale to measure visual severity of wrinkles where five is the most sever rating (extreme), from baseline, as evaluated at the 18 month visit.
The majority of subjects in the study (92.0%) had never received treatment with a dermal filler in the nasolabial folds prior to participating in the study.
Effectiveness Results
At 18 months after the initial treatment, the blinded evaluator determined that:
97% of the nasolabial folds retreated at 4.5 months displayed at least one grade WSRS improbmentover baseline, with a mean change in the wrinkle severity score of 1.7 units.
95% of the nasolabial folds retreated at nine months desplayed at least one grade WSRS improvement over b aseline, with a amean change inwrinkles everity score of 1.6 units.
Saftey Results
Injection-site reactions were assessed during the study. The mmost common adverse events were swelling (24%), bruising (19%), and pain/soreness (5%); none were serious or unexpected.
Safety Information
Restylane® is inidicated for the correcftion of moderate to severe facial wrinkles and folds, such as nasolabial folds. Teh most commonly observed side effects are swelling, redness, pain, bruising, and tenderness at the injection site, which typically resolve inless than seven days. Avoid exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness have resolved. Safety has not beenestablised for use during pregnancy, when breastfeeding, or in patiens uinder 18 years.
Restylane® is available only through a licensed practitioner. Complete product and safety informationis available at http://www.medicis.com/products/pi/pi_restylane.pdf
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