The following is a summary of “A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements,” published in the July 2023 issue of the Dermatologic Surgery by Alexiades et al.
Smoothness, fine lines, and hydration can be used to evaluate the epidermis quality. VYC-12L is a recently developed hyaluronic acid filler to enhance the epidermis quality. This was a randomized, blinded evaluation of the safety and efficacy of intradermal VYC-12L treatment for enhancing the smoothness, fine lines, and hydration of cheek skin.
Participants (≥22 years) with moderate-to-severe Allergan Cheek Smoothness Scale (ACSS) scores were randomly assigned to receive either VYC-12L or a placebo (no treatment with discretionary treatment). About one month after the last injection (initial or touch-up), the effectiveness was evaluated based on the responder rate (≥1-grade improvement from baseline on both cheekbones) using the investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), as well as tissue dielectric constant probe-measured skin hydration. Safety was evaluated at all times. About 86.1% of participants (n = 131 for VYC-12L; n = 71 for control) were female, with a median age of 58.0 years.
At month 1, the ACSS and AFLS responder rates in the VYC-12L group were statistically significantly higher than in the untreated controls (p<.001). The VYC-12L ACSS and AFLS response rates remained stable throughout the 6-month follow-up. Around 6 participants reported adverse events related to treatment, but none led to study termination. VYC-12L (57.9%, and 58.3%, respectively) is an effective and well-tolerated treatment for the long-term enhancement of the smoothness, fine lines, and hydration of cheek skin.
