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

Abstract

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.

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements

“…22,23 Improved hydration may be due to properties of the HA gel that allow it to occupy space in the tissue and hold water 15,24 and/or due to physical interactions of the HA gel with the surrounding tissue altering how skin regulates the transport of water. 25 The total median injection volume (both cheeks added) for initial and touch-up treatments combined was 4.0 mL for the VYC-12L and DTC groups and was 4.7 mL for the repeat treatment group. Allowable injection volumes were based on a prior study of VYC-12L; 17,18 however, in clinical practice injectors using VYC-12L may inject smaller volumes.…”

“… 22 , 23 Improved hydration may be due to properties of the HA gel that allow it to occupy space in the tissue and hold water 15 , 24 and/or due to physical interactions of the HA gel with the surrounding tissue altering how skin regulates the transport of water. 25 …”

Stabilized composition of 26 mg/mL of high molecular weight HA for subcutaneous injection to improve skin quality

“…-1.6% L-HA + 1.6% H-HA (Profhilo, IBSA, Italy) is a mixture of low molecular weight HA (0.08-0.10 million Daltons) at 16 mg/mL and high molecular weight HA (1.10-1.40 million Daltons) at 16 mg/mL into buffered sodium chloride solution [12] , indicated to be injected in the dermal/subcutaneous levels. This product was used as a comparator for the cohesivity, oscillatory shear stress, and flow tests and the ex vivo study.…”

Wide Use of Hyaluronic Acid in the Process of Wound Healing—A Rapid Review

“…The importance of HA in otorhinolaryngological and oral surgical procedures is steadily growing, despite its main association with dermatology and cosmetic surgery [79][80][81][82][83][84][85].…”