Merz, the manufacturer of a hyaluronic acid filler called Belotero is hoping to achieve FDA approval soon. Their product is currently used in Europe but is new to the U.S. market. So far, it has only been used in this country in clinical trials. This includes a 24 week study conducted by researchers at the New York University School of Medicine. The results of this study have shown that Belotero performs well in comparison with bovine collagen wrinkle fillers.
Over 100 patients (mostly white women in their 50s) participated in this trial. They had deep nasolabial folds – smile lines that reach from the sides of the nose to the corners of the mouth. Each patient received the Belotero gel injection on one side of their face and bovine collagen on the other. The patients were pretested for bovine collagen allergy to ensure that it was safe for them to participate.
The doctors involved in the study were permitted to use their own preferred technique for injecting both wrinkle fillers. They were also allowed to provide a topical anesthetic or a nerve block to numb the area without distorting the tissue (a problem that can occur with local anesthetics injected into a treatment site). They were also given the opportunity to do a touch up session with each patient at the two week mark if needed – a typical aspect of the injectable filler process used to ensure an optimal outcome. After this, patients’ results were evaluated at 2 week intervals for the first 8 weeks and then at weeks 12, 16, and 24.
Investigators (who were not told which side of each patient’s face received which filler) used a Wrinkle Severity Rating Scale and other assessment tools to evaluate the outcome. From the 12 through 24 week marks, Belotero demonstrated a more significant improvement than bovine collagen. Patients also had somewhat longer lasting correction with the Belotero product. Some patients reported negative side effects including nodules under the skin. This complication was slightly more common with collagen.
Other Potential Benefits of Bolero
Unlike some other HA wrinkle fillers on the market, Belotero does not appear to create a bluish grey tinge when injected just under the skin. It can also be used for injection deeper in the tissue. In another study spanning a year and a half, most patients were able to go 12 to 18 months between treatments. This will make Belotero one of the longer lasting HA fillers on the U.S. market if it is approved.