According to data published in the current issue of Dermatologic Surgery, Restylane (non-animal, stabilized hyaluronic acid gel) provides safe and effective correction of nasolabial folds and longer-lasting results than Zyplast (bovine collagen). Restylane is currently under review by the U.S. Food and Drug Administration to receive marketing approval for the treatment of facial lines, wrinkles and folds.
"Over the last 20 years, bovine collagen has been the mainstay of injectable materials used to fill facial wrinkles and folds, despite the fact that it only lasts for about three to five months and requires that patients get a double allergy test at least six weeks prior to treatment," said Rhoda Narins, M.D., the paper's lead author and clinical professor of dermatology at New York University School of Medicine. "Restylane is the closest we've come to finding the ideal injectable. As compared to collagen, it can effectively restore volume to folds and wrinkles with a smaller amount of material, it lasts almost twice as long, and does not pose a risk of disease transmission or allergies, since it's non-animal derived."
Restylane is a non-animal stabilized hyaluronic acid (HA) gel currently used in Europe, Canada and Australia in over 1 million procedures to correct facial wrinkles and folds, and enhance lips. HA is naturally found in the body and is used by cells to provide volume and fullness to the skin. Restylane acts by attracting and binding water molecules which provide the volume to lift dermal tissue and restore a smoother, fuller and younger contour to the face. And, since it is a natural component of skin, Restylane is broken down into carbon dioxide and water via the body's metabolic processes over time.
During this six month study, the nasolabial folds (lines descending from either sides of the nose) of patients were randomly treated with Restylane on one side of the face and Zyplast on the other. At six months Restylane provided superior fold correction compared to Zyplast in more than half (56.9 %) of patients and significant treatment differences in favor of Restylane were evident as early as two months after the treatment. Results from previous non-controlled studies of Restylane have also shown a considerable degree of correction persisting for more than six months after treatment. ,
"The most remarkable finding of this study was that by six months almost 70 percent of Zyplast-treated folds had returned to their pre-treatment condition, compared to only about 30 percent of Restylane-treated folds," added Dr. Narins. "This clearly supports that Restylane should be the treatment of choice for effective and long-lasting fold correction."
In addition, both treatments were safe and well-tolerated, with local injection--site reactions such as redness and tenderness being the most commonly reported (<12.5% of patients) temporary adverse events.
ABOUT THE STUDYThis randomized, double-blind study was conducted at six centers in the United States and recruited 134 patients seeking soft tissue augmentation for correction of bilateral nasolabial folds. To qualify for inclusion in the study, patients were required to have moderate to severe nasolabial folds, as determined by the treating investigator using a Wrinkle Severity Rating Scale (WSRS) developed specially for the study. In addition, patients had to be willing to abstain from other cosmetic procedures for the duration of the study. Each patient received Restylane in one nasolabial fold and Zyplast in the opposite nasolabial fold. The response to the initial injection was evaluated at 2 weeks, and if the cosmetic result on one or both sides was deemed sub-optimal, a repeat treatment was performed. The touch up procedure was repeated at 2-week intervals until an 'optimal cosmetic result' was achieved, which was established as the baseline.
Clinical efficacy assessments were then conducted at 2, 4 and 6 months after baseline using the WSRS and Global Aesthetic Improvement Scale (GAIS) . Adverse events were assessed by the treating investigator for severity and relationship to the study treatment. The primary efficacy endpoint was the WSRS score at six months, while the secondary endpoints were WSRS scores at two and four months, GAIS ratings at baseline, 2, 4 and 6 months, and the number of treatment sessions required to achieve an optimal result.
To view the complete study, visit the Dermatologic Surgery web site at http://www.blackwellpublishing.com/journals/DSU/.
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