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 203 volunteers with signs of facial aging received a single injection of BtHCROSS®. Follow-up visits were established at 21 days, six months and nine 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 MFVLS and WSRS scores showed a statistically significant improvement at both six and nine 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, six and nine 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 nine months.