Safety And Efficacy Of Princess^® FILLER Lidocaine In The Correction Of Nasolabial Folds

Abstract

Purpose

Nasolabial folds (NLFs) are one of the most noticeable signs of facial aging. NLFs negatively affect self-confidence and social acceptance often leading to a person’s desire to improve their appearance using dermal fillers. The hyaluronic acid injectable gel implant Princess^® FILLER Lidocaine (PFL) is a minimally invasive easy to administer the product. In this investigation, we assessed the safety and efficacy of PFL to correct moderate to severe NLFs over a 36-week period.

Methods

Adult women and men with moderate to severe NLFs received one injection of PFL to both NLFs. After 2 weeks, a touch-up treatment could be performed, if deemed necessary by the investigator. The change in NLF severity was assessed using the Nasolabial Fold Severity Rating Scale (NFL-SRS) developed by Croma-Pharma and the Global Aesthetic Improvement Scale (GAIS).

Results

Out of 60 analyzed subjects, 59 (98.3%) had improved their NLF severity by at least 1 grade on the NFL-SRS at week 4, 58 subjects (96.7%) at weeks 24 and 36. All subjects showed aesthetic improvement (GAIS), at weeks 4 and 24. The investigator judged the aesthetics as very much improved (score of 1) in 45 (75.0%) at week 4, 48 (80.0%) at week 24, and in 39 of 60 subjects, respectively (65.0%) at week 36. Thirty-six weeks post-initial treatment, 56 of 60 subjects (93.3%) were very satisfied or satisfied with the treatment. Adverse device effects (ADEs) were mild or moderate and resolved at latest 25 days post-onset. The most commonly reported ADEs were injection site hematoma and injection site pain.

Conclusion

PFL was safe and effective in reducing the severity of NLFs. Most subjects were (very) satisfied with the treatment outcome throughout a 36 weeks investigation period.

Keywords:

• hyaluronic acid
• dermal filler
• lidocaine hydrochloride
• mid to deep dermis
• facial wrinkles
• injection

Data sharing statement

The authors do not intend to share individual’s de-identified participant data, nor other study-related documents.

Disclosure

DG and MS were principal investigators in this investigation. SH and MP are employees of Croma-Pharma GmbH. ZIS and SCR are former employees of Croma-Pharma GmbH. MP is partial owner of Croma-Pharma. The authors report no other conflicts of interest in this work.