Study Demonstrates Restylane(R) Effect Lasted 18 Months In 97% Of Patients With One Repeat Injection

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 11 Feb 2009 - 1:00 PDT

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Recent clinical data show that Restylane(R) lasted 18 months in 97% of patients with one repeat injection. Restylane(R) is the only HA filler with an 18-month FDA-approved duration claim.

These data were generated in a controlled, randomized, evaluator-blinded study that assessed the safety and effectiveness of two different retreatment schedules, 4.5 months or 9 months, after initial treatment of nasolabial folds (NLF). Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). 92% of patients were naive to dermal fillers so had no residual effects from earlier treatment.

Key findings from the study include:

-- At 18 months, 97% of patients continued to show improvement in NLF correction with one repeat injection

-- Correction with Restylane(R) lasted for 18 months, regardless of retreatment schedule

-- At 18 months, patients still had a 1.7 grade improvement in WSRS over baseline

-- Adverse events were primarily swelling (24%) and bruising (19%); none were serious.

For more information, please contact Ilisa Wirgin or Elyse Koenig of LaForce + Stevens at 212.242.9353 x 140/167.

Restylane(R) is available only through a licensed practitioner. Complete product and safety information is available at http://www.RestylaneUSA.com.

Safety information

Restylane(R) is indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The most commonly observed side effects are swelling, redness, pain, bruising, and tenderness at the injection site, which typically resolve in less 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 been established for use during pregnancy, when breastfeeding, or in patients under 18 years.

Restylane is a trademark of HA North American Sales AB.

Medicis Aesthetics Inc.
http:// www.medicis.com