Effectiveness and Safety of
RHA4
Versus Comparator Product for Midface Volume Deficiency: A Randomized, Prospective, Multicenter Clinical Study
Ava Shamban, Sabrina Fabi, John Joseph, Sue Ellen Cox, Susan Weinkle, Joely Kaufman‐Janette, Jeffrey Dover, Steven Dayan, Laura Picault, Alice Melotti, Stefania Ballarini ABSTRACT
Background
Hyaluronic acid (HA) dermal fillers are widely used to correct age‐related midface volume deficits and improve self‐perceived attractiveness. TEOSYAL RHA 4 (also FDA‐approved as RHA Dynamic Volume) (RHA4) is a high‐strength, moderate‐stretch HA volumizing injectable designed to maintain facial dynamics.
Objectives
To evaluate the effectiveness and safety of RHA4 versus an active comparator (Juvéderm Voluma XC) for correction of midface volume deficits (MVD).
Methods
In this controlled, randomized (3:1), blinded live‐evaluator, multicenter prospective clinical study, the primary outcome was the change from baseline in Teoxane Midface Volume Deficit Scale (TMVDS) score, while the co‐primary endpoint was the proportion of responders with ≥ 1‐grade improvement on the TMVDS at 8 weeks post‐treatment.
Results
Overall, 201 subjects were enrolled (152 RHA4; 49 comparator); 74.6% received multilayer injections in deep and superficial midface fat pads. Mean TMVDS change at 8 weeks was −1.3 ± 0.8 with RHA4 and −1.3 ± 0.6 with comparator ( p = 0.377; upper 95% CI bound < 0.5, non‐inferiority demonstrated). The proportion of subjects achieving ≥ 1‐grade improvement (responder rate) was 87.0% (RHA4) and 90.5% (comparator) ( p = 0.786); the co‐primary endpoint was met (comparator responder rate > 70%). TMVDS responder rate following RHA4 treatment remained above 65.6% for 52 weeks, while subject‐assessed aesthetic improvement and satisfaction remained above 81.3% and 82.8%, respectively. RHA4 exhibited a good safety profile similar to the comparator.
Conclusions
RHA4 was shown to be as effective as the active comparator for correction of MVD, providing sustained aesthetic outcomes, high satisfaction, and good tolerability.