Effectiveness and Safety of RHA3 vs a Comparator Product for Lip Augmentation: A Randomized, Controlled, Prospective, Multicenter Clinical Study.

BACKGROUND

Lip augmentation using dermal fillers is increasingly popular, but often requires large volumes and regular touch-ups, whereas poor techniques and product selection can result in unnatural-looking lips. The RHA collection was designed to have less rigidity, allowing the products to adapt to facial animation. In particular, RHA3 has been approved in Europe for lip volumization.

OBJECTIVES

The authors of this study aimed to evaluate the effectiveness and safety of RHA3 vs an active comparator for lip augmentation in the US population.

METHODS

This was a randomized, controlled, double-blinded, multicenter clinical study. The primary endpoint aimed to demonstrate the noninferiority of RHA3 vs the comparator using the Teoxane Lip Fullness Scale (TLFS), assessed by the blinded live evaluator, 12 weeks after treatment. Secondary objectives included improvement on the TLFS, Global Aesthetic Improvement Scale, patient satisfaction, and natural look/feel of the lips up to 52 weeks. Safety assessment covered adverse events (AEs), common treatment reactions, and injection site pain.

RESULTS

A total of 202 patients were enrolled. RHA3 was considered statistically noninferior to the comparator for lip augmentation among patients with TLFS Grades 1 to 3. It provided sustained lip volume enhancement over time, with high rates of aesthetic improvement and patient satisfaction. Most RHA3-treated patients achieved a natural look and feel of the lips that was maintained throughout the study period. Most AEs were mild to moderate, with no late-onset reactions or angioedema reported.

CONCLUSIONS

RHA3 was effective for lip augmentation, providing sustained aesthetic improvement, high satisfaction, and good tolerability. These findings support the use of RHA3 as a uniquely dynamic option for natural-looking lip augmentation.