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Clinical Trials
7
1 active
Approvals
0
Total approvals
Agencies
Regulatory bodies
Founded
N/A
Active, not recruiting
1
14.3%
Completed
3
42.9%
Recruiting
2
28.6%
Unknown
No approval data available
- Evolus Inc. has submitted its final Premarket Approval application to the FDA for Evolysse Sculpt, an injectable hyaluronic acid gel designed to restore mid-face volume. - The application is supported by a pivotal 24-month study of 304 patients comparing Evolysse Sculpt to Restylane-Lyft in a multicenter, double-blinded, controlled trial. - Evolysse Sculpt utilizes novel Cold-X technology that preserves the natural structure of hyaluronic acid molecules for longer-lasting, natural-looking results. - FDA approval is expected in the second half of 2026, positioning the product among the few dermal fillers currently indicated for the mid-face area.
