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A Randomized, No-Treatment-Controlled Study to Evaluate Effectiveness and Safety of SB-NASHA Injectable Gel for
Amir Moradi1, Sabrina Fabi2, Sachin M Shridharani3
1Moradi MD Cosmetic Surgery, Vista, California.
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.