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

Abstract
Background: Hyaluronic acid (HA) fillers are quite commonly used since several years
for soft tissue augmentation.
Aim: The purpose of this study was to evaluate primarily the safety and secondarily
the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24 mg with Lidocaine
3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles
and lip augmentation.
Method: Patients between the age groups of 18 and 75 years, 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 6 months after baseline. Clinical efficacy
was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic
Improvement Scale (GAIS).

Results: The mean pain score was found to be 2.57 ± 2.06 immediately after injec-
tion which was reduced to 0.1 ± 0.675 at 15 min and this further subsided to “No

Pain” in any of the participants at 60 min post the injection. WSRS mean score before
treatment was 2.76, which were significantly reduced to 2.14, at 3 months. Majority

of participants found an improvement in the marionette line severity. Also, signifi-
cant improvements were seen in the perioral and lip areas. The Study filler was well-
tolerated and no side effects were reported.

Conclusion: The study indicates that this particular filler, HA+L, is useful for cosmetic
improvements in the nasolabial folds and for enhancement of the lips.

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