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

作者：Prager Welf^*; Steinkraus Volker

来源：European Journal of Dermatology, 2010, 20(6): 748-752.

DOI：10.1684/ejd.2010.1085

• Belotero (R) Basic
• hyaluronic acid dermal fillers
• monophasic
• nasolabial folds
• Restylane (R)

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 (R) Basic (monophasic) and Restylane (R) (biphasic), for correction of nasolabial folds (NLF). Twenty subjects with bilateral, symmetrical NLF were randomized to receive a single injection of Belotero (R) Basic and Restylane (R) 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 (R) Basic resulted in a significantly greater improvement in evenness compared with Restylane (R) at Week 4 (mean intra-individual difference between treatments in PRIMOS measurement: -37.6 mu m; 95% CI: -65.4; -9.9). Subject-rated secondary endpoints demonstrated numerical differences in favour of Belotero (R) Basic when compared with Restylane (R). Both dermal fillers were equally well tolerated, as 85% (Belotero (R) Basic group) and 80% (Restylane (R) group) rated the tolerability of both treatments as "good" to "very good".

• 出版日期2010-12