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The U.S. injectable market has added lidocaine-containing versions of popular hyaluronic acid (HA) fillers, and additional fillers are expected, an expert says. Juv?derm XC (HA, lidocaine; Allergan) was available in Europe for about a year before earning Food and Drug Administration (FDA) clearance in February 2010. Restylane-L and Perlane-L (HA, lidocaine; Medicis) also won FDA approval in February 2010.
Nashville, Tenn. - The U.S. injectable market has added lidocaine-containing versions of popular hyaluronic acid (HA) fillers, and additional fillers are expected, an expert says.
In all these products' clinical trials, "The incorporation of lidocaine has surely provided a higher comfort level for patients," says Michael H. Gold, M.D. These products performed similarly to their lidocaine-free predecessors in terms of efficacy and safety, he says. Dr. Gold is medical director at Gold Skin Care Center, Advanced Aesthetics Medical Spa, the Laser and Rejuvenation Center and the Tennessee Clinical Research Center, and clinical assistant professor, division of dermatology, Vanderbilt University School of Medicine and School of Nursing, Nashville, Tenn.
In the 72-patient trial of Juvéderm XC, Dr. Gold says he and his co-investigators actually blindfolded patients, all of whom were randomized to treatment in each nasolabial fold with either Juvéderm or Juvéderm XC. Patients assessed pain levels during treatment, then 30 minutes and 24 hours post-treatment. Altogether, 93 reported less pain with the lidocaine formulation versus the original formulation (Weinkle SH, Bank DE, Boyd CM, et al. J Cosmet Dermatol. 2009 Sep;8(3):205-210).
In Medicis' studies, investigators injected patients with either Restylane-L or Perlane-L in one cheek and its lidocaine-free counterpart in the other. Subjects evaluated injection-site pain for each side of the face using a straight-line visual analogue scale (VAS). This analysis revealed a within-patient difference of at least 10 mm (a distance that investigators defined as meaningful) in 71.7 percent of Restylane-L patients and 95 percent of Perlane-L patients (Restylane-L injectable gel with 0.3 percent lidocaine, Perlane-L injectable gel with 0.3 percent lidocaine. Scottsdale, Ariz: Medicis Aesthetics; January 2010).
Dr. Gold says based on his clinical experience, when undergoing an injection that includes even a small percentage of lidocaine, "Most patients say they barely feel the second stick. To me that is the home run of lidocaine in these fillers."
In July 2009, the FDA also cleared a method for physicians mixing lidocaine with Radiesse (calcium hydroxylapatite, BioForm). "Originally, I was against doctors mixing a lot of fillers because I was afraid of potential changes in the products themselves," Dr. Gold says. But once the FDA clears these products, especially those premixed by manufacturers, "I'm pretty comfortable with it."