Worldwide clinical program of an innovative HA technology
Objectives: Symatese is pleased to present its new technology, used in the therapeutic as well as in the aesthetic field. Especially, the HA filler range based on this technology has been assessed through a strong international clinical program, in Europe, US, and China.
Introduction: All five reference products of this range have been clinically assessed in Europe (total number of patients: 317) and are now undergoing clinical trials in the US and China.
Materials / method: LIFT Filler allows a durable result in the treatment of nasolabial folds, with a gain of 3 months in terms of WSRS score vs the Control.
In a second study, LIPS Filler showed a natural and long-lasting effect in lips augmentation and/or contouring (12 months without touch-up). This result has been reinforced by the use of SMOOTH Filler in perioral lines and nasolabial folds. The range is completed by the SCULPT Filler, the most projecting filler of the range and a last product dedicated to infraorbital hollows.
Results: This program is expanding with 2 ongoing US clinical investigations, with SMOOTH and LIFT in the nasolabial folds vs Control (6 centers, 140 patients), and SCULPT vs Control (11 centers - 308 patients) to restore the volume of the cheeks. 2 studies are planned in 2024 for eye and lips indications with LIPS and EYE.
China is also a major territory for this program, with a clinical study underway on the LIFT vs Control in nasolabial folds (6 centers – 314 patients).
Conclusion: Two other clinical studies have been launched to assess the SCULPT (6 centers – 356 patients) to restore midface volume and contouring, and SMOOTH (8 centers – 138 patients) in perioral lines treatment in Chinese population. The two other products of the range, dedicated to lips and eye, are also planned to be evaluated in China within the next months.
The new Symatese’s technology has been evaluated though a large-scale international clinical program. This is a unique schedule in the industry involving 1 435 patients worldwide to date.