Long-term Safety and Effectiveness of Cold-Crosslinked Hyaluronic Acid Fillers: Multicenter, Randomized, Controlled,...

Area of Science:

• Dermatology
• Aesthetic Medicine
• Biomaterials Science

Background:

• Introduction of EVOLYSSE FORM (EVLF) and EVOLYSSE SMOOTH (EVLS), novel hyaluronic acid fillers utilizing an innovative cold crosslinking process.
• These fillers represent advancements in dermal filler technology for aesthetic applications.

Purpose of the Study:

• To evaluate the safety and effectiveness of new cold-crosslinked hyaluronic acid fillers.
• To gather data supporting US regulatory approval for correcting moderate to severe dynamic facial wrinkles and folds.
• To compare the performance of cold-crosslinked fillers against a traditionally-crosslinked filler.

Main Methods:

• A randomized, controlled, split-face study involving 140 subjects with moderate to severe nasolabial folds.
• One nasolabial fold received a cold-crosslinked filler (EVLF or EVLS), while the contralateral fold received Restylane-L (RESL).
• Follow-up extended to 12 months, including optional retreatment and subsequent safety monitoring.

Main Results:

• The cold-crosslinked fillers demonstrated non-inferiority and statistical superiority in wrinkle severity reduction at 6 months.
• EVLF showed statistically significant improvements over RESL through 12 months; EVLS showed significant improvements at 6 and 9 months.
• High responder rates were observed across all assessment groups (evaluators, investigators, subjects) using the Global Aesthetic Improvement Scale.
• Significant improvements in the FACE-Q Appraisal of Nasolabial Folds were noted for all treatment groups.

Conclusions:

• The novel cold-crosslinked hyaluronic acid fillers (EVLF and EVLS) are safe and effective for nasolabial fold correction.
• Results indicate sustained efficacy for up to one year.
• The cold crosslinking process offers a promising alternative for dermal filler development.