Abstract
To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation. Adults (n = 180; aged 18-65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (≤1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study. Statistically significantly more MLFS responders (≥1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p < .001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p < .001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events. SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8 weeks, with visible results reported in the majority of participants 6 months after treatment.
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