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6/19/2010
Fillers with lidocaine among latest injectable advancements
The U.S. injectables market has added lidocaine-containing versions of popular hyaluronic acid (HA) fillers, and additional fillers are expected to enter the market, an expert says.
Fillers with lidocaine among latest injectable advancements

The U.S. injectables market has added lidocaine-containing versions of popular hyaluronic acid (HA) fillers, and additional fillers are expected to enter the market, an expert says.

Juvderm 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.


Dr. Gold

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.


FILLER STUDIES In the 72-patient trial of Juvderm 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 Juvderm or Juvderm 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."

ARTEFILL AND FUTURE FILLERS As for other fillers, Dr. Gold says the approximately 1,000 patients enrolled in a five-year safety study of Artefill (polymethylmethacrylate, Suneva) are doing "exceptionally well" 18 months post-treatment (Narins RS, Cohen SR. Dermatol Surg. 2010; 36(s1):766-774). "Some people cringe every time they hear the phrase 'permanent filler,' but based on what has been published to date, Artefill is exceptionally safe," says Dr. Gold, who has enrolled 20 patients in this study.

Fillers that soon will reach the American market include Belotero Balance (HA, Merz), which Dr. Gold says is awaiting FDA approval for nasolabial folds correction. Sculptra Aesthetic (poly-L-lactic acid, Sanofi-Aventis) earned indication for volume enhancement of the nasolabial folds in July 2009.

Internationally, he says, the Belotero family includes three products Soft, Basic and Intense for superficial, medium and deep injection, respectively.

Other European HA fillers that eventually could come to the United States include the Teosyal family (Teoxane) and the Glytone family (Pierre Fabre Dermo-Cosmtique). The latter includes the antioxidant mannitol with a combination of free HA fragments and reticulated HA gel, Dr. Gold says.

DISCLOSURES:
Dr. Gold is a consultant for Allergan and Merz and a speaker for Allergan, Medicis, Mentor/Johnson & Johnson and Merz. He has performed research for Allergan, Medicis, Mentor and Merz.


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