The injectable, known as Restylane Contour in the US, achieved a 94.4% responder rate at six months, with improvements sustained through 12 months.
Galderma announced positive topline results from a clinical study evaluating Restylane Volyme for the correction of moderate-to-severe temple hollowing in China, meeting its primary endpoint with a 94.4% responder rate at six months. The hyaluronic acid injectable, known as Restylane Contour in the US, demonstrated sustained response rates through month 12 with no reports of granulomas or treatment-related serious adverse events, the company stated.
In the US, the US Food and Drug Administration cleared Restylane Contour for the correction of temple hollowing in adults over age 21 in March 2026. The clearance expanded the injectable’s use beyond cheek augmentation and correction of midface contour deficiencies.
The latest findings are intended to support regulatory expansion for the Restylane portfolio in China, which Galderma identified as one of the fastest-growing aesthetics markets globally.
Trial Design and Clinical Findings
The randomized, evaluator-blinded study recruited 162 adults across six sites in China, allocating participants 2:1 to either the Restylane Volyme treatment arm or an untreated control group.
At month six following final treatment, 94.4% of patients in the treatment group showed at least a one-grade improvement from baseline in temple hollowing across both temples, compared to 2.0% in the control group, according to the trial data. Blinded-evaluator responder rates measured by the Galderma Temple Volume Deficit Scale remained high through month 12, the company reported. Additionally, treating investigators determined that 91.3% of participants achieved bilateral improvement on the Global Aesthetic Improvement Scale through month 12, according to the release.
“Temple hollowing is a common concern among patients seeking facial rejuvenation, particularly for those experiencing medication-driven weight loss, yet treatment options in China remain limited. These results demonstrate that Restylane Volyme can provide effective, natural-looking correction with high levels of patient satisfaction and a robust safety profile. As demand for individualized aesthetic treatments continues to grow in China, expanding the range of evidence-based solutions available will be increasingly important,” says Zhao Hongyi, study principal investigator, and director and chief of the department of plastic surgery at Beijing Hospital in China, in a release.
Patient Outcomes and Delivery Method
Patient-reported outcomes showed high satisfaction rates starting at month three and continuing through the end of the evaluation period. According to the release, more than 84% of participants reported satisfaction with both the natural look and the natural feel of their temples through month 12. Furthermore, more than 90% stated they would recommend the treatment to a friend, over 86% expressed willingness to repeat the procedure, and 50% felt comfortable resuming social engagements within 24 hours of initial treatment.
Galderma noted that Restylane Volyme is formulated as a flexible gel using OBT technology, engineered to distribute within tissue to balance facial contours. Product administration utilizes a patent-pending dual-layer technique that combines both needle and cannula delivery to facilitate precise, customized placement, according to the manufacturer.
Aesthetic Indications and Regional Growth
According to Galderma, temple volume depletion occurs naturally with aging and has also become more prevalent due to the rise of medication-driven weight loss. While Restylane Volyme previously launched in China for mid-face applications, Galderma plans to leverage these clinical data to broaden cleared treatment areas for healthcare professionals in the country.
“These positive topline results further strengthen the clinical evidence supporting Restylane Volyme and mark an important step in our strategy to expand the Restylane portfolio in China. As one of the world’s fastest-growing aesthetics markets, China presents a significant opportunity to address evolving patient needs with science-backed, differentiated solutions. This study supports our ambition to broaden the indications available to practitioners and patients, while reinforcing Galderma’s leadership in Injectable Aesthetics through continued investment in innovation and clinical research,” says Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma, in a release.
Photo caption: Before and after photo of a patient treated with Restylane Volyme for the correction of moderate-to-severe temple hollowing.
Photo credit: Galderma
