Evolus’ Evolysse Form and Evolysse Smooth are safe and effective for the correction of nasolabial folds, with results lasting for one year, according to research published in the Aesthetic Surgery Journal.

Evolysse Form and Evolysse Smooth are hyaluronic acid (HA)-based fillers that are made with  Cold-X Technology, a cold crosslinking process that utilizes near-freezing temperatures to preserve the natural HA structure for a natural look.

The multicenter, randomized, controlled, double-blind study followed 140 patients through 12 months and evaluated the long-term safety and effectiveness of Evolysse Form and Evolysse Smooth for the correction of moderate to severe dynamic facial wrinkles and folds.

Study Findings

Findings include:

• Statistical Superiority: Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority, the study showed.
• Durability of Results: As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at 6 and 9 months – even as 20% more Restylane-L was used.
• High Patient Satisfaction: More than 80% of subjects reported they would undergo treatment again and recommend it to a friend. FACE-Q and Global Aesthetic Improvement Scale (GAIS) assessments confirmed sustained improvements and high satisfaction through 12 months.
• Favorable Safety Profile: In the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed in the Evolysse™ arm, compared to 1.4% in the control arm.

“One key feature of the Evolysse injectable HA gels that this study and publication highlight is the efficiency of their performance,” says Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus, in a news release. “In the case of Evolysse Form, the same amount of product was used as the control, yet it achieved more correction with statistical significance at every time point over 12 months.”

Similarly, Evolysse Smooth delivered more correction, reaching statistical significance at 6 and 9 months, despite 20% less product being used, he says. “This speaks to the differentiation of the Evolysse collection and its ability to not only meet the evolving needs of both practitioners and patients but outperform one of the market-leading HA gels available today.”