Objectives: To evaluate the effectiveness and safety of VYC-12, a hyaluronic acid injectable gel, for the treatment of superficial cutaneous depressions such as fine lines and the improvement of skin quality attributes such as hydration and elasticity of the full face (cheeks and forehead) and neck (optional) in a 6-month, prospective study.
Introduction: VYC-12 hyaluronic acid injectable gel was designed to treat superficial cutaneous depressions such as fine lines and to improve skin quality attributes such as hydration and elasticity. This prospective, single-arm study aimed to evaluate the safety and effectiveness of VYC-12 treatment on the full face (cheeks and forehead) and neck (optional).
Materials / method: Adults with moderate-to-severe cheek skin roughness on the Allergan Skin Roughness Scale (ASRS) received intradermal VYC-12 injections; touch-up treatment, if needed, was provided ~30 days later. The primary endpoint was the proportion of cheeks with ≥1-point improvement (responder) from baseline ASRS score at month (M) 1 after last treatment. Other assessments included instrument measures of skin smoothness, hydration, firmness, and thickness; investigator-assessed severity of fine lines (Allergan Fine Lines Scale [AFLS]); adverse events; and injection-site responses (ISRs).
Results: Of 131 subjects (261 cheeks), 31 (23.7%) required touch-up (46 cheeks; 17.6%). The ASRS responder rate was 96.2% at M1, 76.3% at M4, and 34.9% at M6. Skin smoothness, hydration, firmness, and thickness significantly improved from baseline to M1 (P<0.05). For 189 cheeks with moderate to severe fine lines (AFLS: 2 or 3) at baseline, the responder rate was 89.4% at M1, 66.7% at M4, and 40.5% at M6. All treatment-related adverse events were mild or moderate. ISRs typically lasted for ≤1 week, as expected. A day after initial treatment, 95% of subjects returned to normal social activities.
Conclusion: VYC-12 was observed to be safe and effective for treating superficial skin depressions and improving skin quality, with effects lasting for 4 to 6 months.
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