FDA Approves Gel Dermal Filler for Facial Wrinkles

Yael Waknine

Disclosures

November 21, 2011

November 21, 2011 — The US Food and Drug Administration (FDA) has approved a gel dermal filler (Belotero Balance, Merz Aesthetics) for the correction of moderate-to-severe facial wrinkles and folds.

The product combines a cohesive polydensified matrix technology with a hyaluronic acid base that attracts water to the injected area to fill and plump the wrinkle in natural way.

Potential treatment areas include nasolabial folds, worry lines, crow's feet, lips/chin/cheek augmentation, marionette lines, smile lines, perioral lines, and wrinkles at the décolletage.

"Belotero Balance filler is...designed to deliver natural-looking results with little recovery time," according to a company news release."[P]atients are able to see a visible softening in their lines for a natural look that lasts," Rhoda S. Narins, MD, lead investigator and clinical professor of dermatology at New York University Medical School, New York City, said in the release.

According to information on the company Web site, patients are able to see the lines and wrinkles on their face softening and becoming less noticeable immediately after treatment. Results improve during the first week or so and continue for about 6 to 12 months before additional treatments are needed.

FDA approval was based on data from a randomized, double-blind, active-controlled, multicenter study (n = 118) in which patients received bilateral treatment with the investigative filler and an approved bovine collagen filler for their moderate-to-severe nasolabial folds.

Efficacy was evaluated using a 5-point Wrinkle Severity Scale (WSRS), ranging in severity from least (0) to most (4).

Results showed that the new dermal filler demonstrated greater reduction in the mean change of the WSRS at all time points and maintained more than 1 point WSRS reduction at week 24 compared with 0.5 for the bovine collagen control. According to the company's Web site, 97% of clinical study patients showed a visible improvement after just 1 treatment.

The most commonly reported adverse event was a short-term, mild to moderate injection-site reaction, including swelling, bruising, and localized nodules. No severe events were reported for either treatment group.

The dermal filler is also approved for aesthetic use in Austria, Germany, Italy, Russia, Switzerland, and the United Kingdom.

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