A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers.

PURPOSE

Age-related changes in skin structure and function can negatively impact skin quality. VYC-12L is a crosslinked hyaluronic acid filler for treating fine lines and improving hydration and elasticity. The goal of this study was to understand skin quality, histologic, and genomic changes underlying long-term clinical benefits of VYC-12L treatment.

PATIENTS AND METHODS

In this prospective, nonrandomized, open-label study, 11 healthy men (n = 2) and women (n = 9) received intradermal VYC-12L treatment on the volar forearm. Clinical probes assessed skin quality at baseline and months 1 and 3 post-treatment. Punch biopsies were collected 1 and 3 months post-treatment to evaluate histologic and genomic changes. Safety was evaluated throughout.

RESULTS

Participants had a mean age of 41 years and Fitzpatrick skin phototypes II (54.5%) and III (45.5%). At months 1 and 3, VYC-12L-treated skin had higher hydration in the stratum corneum than untreated skin. Cutometer measurements indicated treated skin that was firmer and more resistant to deformation. Histology showed increased epidermal AQP3 and Ki67 expression 1 and 3 months post-treatment and a qualitative increase in papillary dermal collagen I at month 3. Genomic analyses demonstrated treatment-related upregulation of genes involved in adipocyte differentiation, lipid metabolism, keratinocyte renewal, and dermal extracellular matrix (ECM) maintenance. Injection site reactions were mild-to-moderate in severity and resolved by month 1. Five participants reported 19 adverse events; most (68.4%) were related to the biopsy and none to VYC-12L.

CONCLUSION

VYC-12L produced changes in hydration, firmness, and ECM density and composition consistent with improved skin properties, demonstrating that VYC-12L can act as a substrate for tissue repair.