TL26: Clinical Trials for Devices with Aesthetic Indications
*Phyllis Marlene Silverman, FDA/CDRH 


Clinical trials for devices intended to produce a change in a visible physical attribute of the human body present particular challenges in study design and analysis. These devices can include injectable wrinkle fillers, saline and silicone gel breast implants, body contouring procedures, and lasers for hair removal or skin resurfacing. This roundtable will explore the challenges encountered in the design and analysis of trials with aesthetic indications such as choosing an appropriate comparator group, maintaining the blind, defining clinically meaningful outcome measures, incorporating the patient’s perspective via patient reported outcomes, and assessing safety and effectiveness from repeated use.