Functional safety assessments used in a randomized controlled study of small gel particle hyaluronic acid for lip augmentation.

Abstract

Dermal fillers are commonly injected in the lips for aesthetic treatment. Small gel particle hyaluronic acid (SGP-HA) is the only filler approved by the US Food and Drug Administration for this indication, based on a pivotal trial of effectiveness and safety. To assess multiple measures of tolerability and lip function in a randomized controlled trial of SGP-HA (without lidocaine) for lip augmentation. Patients were randomized to SGP-HA (n = 135) or no treatment (n = 45) at baseline; all could receive SGP-HA after 6 months. Assessments for tolerability and lip function at clinic visits throughout the study included lip texture, firmness, symmetry, movement, function, and sensation; device palpability; mass formation; and ease of repeat injection. Many assessments were normal (lip function, sensation) or unremarkable (movement, mass formation, ease of reinjection) in most patients. Nearly all abnormalities with other assessments (texture, firmness, symmetry, device palpability) were mild and transient (<4 weeks). Lip augmentation with SGP-HA showed excellent safety with the assessments used in this study. Further study should be conducted to validate these assessments with the goal of developing a comprehensive scale for measuring potential functional complications and risks.