A prospective, open-label, multicentric, single-arm, post-marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation.

Abstract

Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation. The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation. Patients between the age groups of 18 and 75years, who were seeking soft tissue augmentation treatment on the face and with wrinkle severity score (WSS) ≥2 for bilateral Nasolabial Folds (NLF), were included in the study. The appropriate quantity of the filler was injected at the treatment site. Clinical efficacy assessments were conducted independently at 3 and 6months after baseline. Clinical efficacy was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic Improvement Scale (GAIS). The mean pain score was found to be 2.57±2.06 immediately after injection which was reduced to 0.1±0.675 at 15min and this further subsided to "No Pain" in any of the participants at 60min post the injection. WSRS mean score before treatment was 2.76, which were significantly reduced to 2.14, at 3months. Majority of participants found an improvement in the marionette line severity. Also, significant improvements were seen in the perioral and lip areas. The Study filler was well-tolerated and no side effects were reported. The study indicates that this particular filler, HA+L, is useful for cosmetic improvements in the nasolabial folds and for enhancement of the lips.