FDA Approves Third Indication for Facial Filler
The FDA has approved onabotulinumtoxinA (Boxtox Cosmetic; Allergan) for temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval is the third indication for onabotulinumtoxinA for facial treatment areas.
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The approval was based upon results of clinical trials that demonstrated efficacy compared with placebo in the reduction of the severity of forehead lines. Researchers assessed patients at day 30, the primary endpoint, and found that 61% of patients in study 1 and 46% of patients in study 2 met the primary endpoint. Similarly, response rates were seen across 3 treatment cycles with onabotulinumtoxinA.
The most common side effects include, discomfort or pain at the injection site, headache, and eye problems. Other serious reported side effects include, itching, rash, red itch welts, wheezing, asthma symptoms, or dizziness or feeling faint.