A prospective, rater-blind, randomized comparison of the effectiveness and tolerability of Belotero ® Basic versus Restylane ® for correction of nasolabial folds.

The aim of this prospective, rater-blind, randomized, intra-individual, 4-week study was to compare the effectiveness and safety of two hyaluronic acid dermal fillers, Belotero® Basic (monophasic) and Restylane® (biphasic), for correction of nasolabial folds (NLF). Twenty subjects with bilateral, symmetrical NLF were randomized to receive a single injection of Belotero® Basic and Restylane® in a split-face design. The primary endpoint measured intra-individual differences of treatment effects in mean depth and evenness of the NLF target area relative to its edges, from baseline to Week 4, as evaluated by the Phase-shift Rapid In-vivo Measurement of Skin (PRIMOS) system. Assessments were undertaken at Visit 2 (baseline) and Visit 3 (study endpoint). Treatment with Belotero® Basic resulted in a significantly greater improvement in evenness compared with Restylane® at Week 4 (mean intra-individual difference between treatments in PRIMOS measurement: -37.6 μm; 95% CI: -65.4; -9.9). Subject-rated secondary endpoints demonstrated numerical differences in favour of Belotero® Basic when compared with Restylane®. Both dermal fillers were equally well tolerated, as 85% (Belotero® Basic group) and 80% (Restylane® group) rated the tolerability of both treatments as "good" to "very good".

RCT Entities:   Population Interventions Outcomes