SCIENCE-BOOK 29.04.2025 - Flipbook - Page 5
FILLERS
Safety pro昀椀le
Summary of the publication:
01
Efficacy and Safety of Neauvia Intense in Correcting
Moderate-to-Severe Nasolabial Folds: A Post-Market,
Prospective, Open-Label, Single-Centre Study
Authors: Zerbinati N. et al. I Published on 10.06.2024
INTRODUCTION
This prospective, single-center, open-label study aimed to evaluate the safety
and effectiveness of Neauvia Intense, a PEG cross-linked polymeric hydrogel,
in correcting moderate-to-severe nasolabial folds (NLF). The study investigated
aesthetic outcomes, patient satisfaction, and adverse events associated with this
injectable filler.
RESULTS
70 patients were enrolled, 60 completed the study. All received a single
treatment session with Neauvia Intense (1 ml per NLF side).
Responder rates by MFWS (Modified Fitzpatrick Wrinkle Scale):
• 96.6% immediately post-treatment
• 76.6% at 1 month
• 48.3% at 3 months
• 28.3% at 6 months
GAIS (Global Aesthetic Improvement Scale) scores showed:
• 95% rated as “improved”, “much improved”,
or “very much improved” at 1 month
• 91.7% at 3 months
• 26.7% at 6 months
a
b
c
Fig. (a and b) Participant prior to receiving treatment as part of the study and immediately after. (c) Improvement of NLF
with 3D facial reconstructions generated by QuantifiCare® software immediately following treatment.
KEY MESSAGES
The study demonstrated a statistically significant improvement in tissue
depression immediately post-injection (p < 0.001), with sustained effects up to
6 months.
Patient and physician satisfaction, measured by VAS, remained stable over
time, with fluctuations at 4 and 24 weeks after treatment.
Throughout the entire follow-up duration no adverse effects related to the use
of the product were observed.
CONCLUSION
The findings from our study confirm that Neauvia Intense is an effective solution
for correcting moderate-to-severe nasolabial folds, offering significant and lasting
improvements in both tissue depression and overall aesthetic appearance.
Despite statistically significant fluctuations over the observation period, both
medical practitioners and patients expressed heightened satisfaction immediately
after the treatment, with a gradual but sustained decline at the 6-month milestone.
Reference: Zerbinati N, Płatkowska A, Guida S, Stabile G, Mocchi R, Barlusconi C, Sommatis S, Garutti L, Rauso R, Cipolla G, Bettolini L,
Bighetti S. Efficacy and Safety of Neauvia Intense in Correcting Moderate-to-Severe Nasolabial Folds: A Post-Market, Prospective,
Open-Label, Single-Centre Study. Clin Cosmet Investig Dermatol. 2024;17:1351-1363 https://doi.org/10.2147/CCID.S460973
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