Galderma announced Wednesday that its dermal filler Restylane Volyme demonstrated high efficacy and tolerability in a clinical study targeting temple hollowing, meeting its primary endpoints.
Of 162 adults enrolled across six sites in China, participants were randomized 2:1 into treatment or untreated control groups and observed for twelve months. After six months, the investigator's assessment showed improvement of at least one grade in 94.4% of treated patients, compared with 2.0% in the control group. More than 84% of those who received the filler reported satisfaction with the natural appearance and feel of their temples, and no treatment-related serious adverse events were recorded.
Restylane Volyme currently holds regulatory approval in China for mid-face correction. This trial provides the first clinical evidence supporting its use for temple hollowing, an indication for which few treatment options exist in the country. Galderma said it intends to expand the Restylane portfolio in China, a move that could open a new market segment for the product line.
