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Invited Commentary
October 20, 2016

Translating Pivotal Trial Findings to Clinical Practice

Author Affiliations
  • 1Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, University of Illinois, Chicago
JAMA Facial Plast Surg. Published online October 20, 2016. doi:10.1001/jamafacial.2016.1283

In 2003, hyaluronic acid (HA) fillers were approved by the US Food and Drug Administration for the improvement of mild to moderate wrinkles of the nasolabial folds. During the next 13 years, its use has skyrocketed. The emergence of soft-tissue fillers along with neurotoxin has revolutionized the scope, training, and delivery of aesthetic medicine. No longer is surgery the dominant deliverable product; today, it is surpassed 5 times by nonsurgical aesthetic treatments.1 Patients’ demand for nonsurgical alternatives has resulted in exponential growth in aesthetic medicine. However, it has also likely birthed a new patient who demands a quick fix with minimal downtime, pain, and expense, causing physicians to alter how they consider, cradle, and deliver their craft as well. However, efforts to meet the new normal have also greatly benefited the profession. During the past decade, there has been an evolution in aesthetic technique, thought process, and outcome measures: from treating patients with surgery once in a decade to treating with neurotoxins every 3 months, from correcting superficial wrinkles and folds with needles to volumizing and shaping faces with cannulas, from pulling faces to filling faces, from using wrinkle ablation to using wrinkle relaxation, and from improving form and function to satisfying mind and mood. Aesthetic medicine is rapidly evolving to meet the expectations of a millennial generation with elevated attitudes and discerning needs. In addition, nonsurgical aesthetic products chaperoned in by large pharmaceutical companies have resulted in large multicenter clinical trials that allow for a greater number of patients and validated outcome measures.2 Whereas surgery traditionally has not allowed for double-blind, placebo-controlled randomized clinical trials, nonsurgical products do, ushering in a new era in aesthetic research where level I evidence-based medicine is now a reality.3 For the first time, by adhering to strict protocols and respecting the rigors of science, we can better understand what we do and why we do it.4,5

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