Efficacy and Safety of a New Crosslinked Hyaluronic Acid Dermal Filler for Facial Volume Restoration: A Prospective Clinical Trial.

Background: Hyaluronic acid is commonly used as a dermal filler for aesthetic purposes. Crosslinking allows a better performance once injected into the skin. A new filler, known as BtHCROSS, has been developed using a novel crosslinking technology (SARE technology). Objectives: To clinically assess the efficacy and safety of BtHCROSS for facial volumization. Methods: Two hundred and three volunteers with signs of facial aging received a single injection of BtHCROSS. Follow-up visits were established at 21 days, 6 months, and 9 months. Efficacy assessment included the Mid-Face Volume Loss Scale (MFVLS), Wrinkle Severity Rating Scale (WSRS), and Lip Fullness Grading Scale (LFGS). Global Aesthetic Improvement Scale (GAIS) and Likert's patient satisfaction questionnaires were also registered. Biometric parameters were assessed using Visioscan, Cutometer, Moisturemap, and Visioface tools. Adverse events related to the study treatment were registered throughout the duration of the study. Results: Mid-Face Volume Loss Scale and WSRS scores showed a statistically significant improvement at both 6 and 9 months. Early noticeable results were also observed after 21 days in LFGS and WSRS scales. The specialist MD reported a GAIS improvement in more than 88%, 92%, and 76% of the volunteers at 21 days, 6, and 9 months, respectively, and the satisfaction percentage was above 70% in all cases. Biometric analysis showed a rapid and statistically significant improvement, maintained during the follow-up period. Conclusions: This study demonstrates that a single injection of BtHCROSS is safe and effective for the management of facial volumization for up to 9 months. Level of Evidence 2 Therapeutic: For image description, please refer to the figure legend and surrounding text.