Abstract / Summary
BACKGROUND SB-NASHA is an injectable hyaluronic acid product for aesthetic treatment, shown to improve skin-quality parameters (such as hydration) and fine lines. OBJECTIVE The aim of this randomized, evaluator-blinded, no-treatment–controlled, multicenter study was to evaluate the effectiveness and safety of SB-NASHA for the correction of décolletage wrinkles. PATIENTS AND METHODS Subjects with moderate-to-severe wrinkles on the Galderma Décolletage Scale (GDS) were randomized 3:1 to the SB-NASHA group or no-treatment group. The study was divided into 2 stages with similar treatment and follow-up periods. RESULTS In total, over both stages, 192 subjects were randomized to the SB-NASHA group ( n = 144) or no-treatment group ( n = 48). An additional 19 subjects with Fitzpatrick skin type (FST) V-VI were treated without randomization and included only in the safety population. The GDS responder rate was statistically significantly higher with SB-NASHA versus no treatment at Week 12 (73.6% vs 18.8%, respectively; primary end point), Week 24 (86.9% vs 34.9%), and Week 32 (80.8% vs 40.9%); all p < .001. GAIS improvement rates assessed by the treating investigator were higher for SB-NASHA versus no treatment at Week 12, Week 24, and Week 32 in both stages. All AEs related to study product or injection procedure were mild/moderate in intensity. CONCLUSION Treatment of the wrinkles in décolletage area with SB-NASHA was effective and well tolerated.