John Libbey Eurotext

European Journal of Dermatology

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A prospective, rater-blind, randomized comparison of the effectiveness and tolerability of Belotero ® Basic versus Restylane ® for correction of nasolabial folds Volume 20, numéro 6, November-December 2010

Auteurs
Dermatologikum Hamburg, Stephansplatz 5, D-20354 Hamburg, Germany

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”.