Restylane Volyme Study in China Shows Durable Correction of Temple Hollowing Through 12 Months

# Study highlights

At the primary endpoint (month six after final treatment), 94.4% of patients in the treatment arm showed at least a one-grade bilateral improvement on the Galderma Temple Volume Deficit Scale. The untreated control group showed a 2.0% responder rate at the same time point. Blinded-evaluator responder rates remained high through month 12.

# Outcomes and patient-reported results

Investigators reported additional measures of benefit through month 12. Treating investigators judged 91.3% of participants to have bilateral improvement on the Global Aesthetic Improvement Scale through month 12.

Patient-reported outcomes demonstrated high satisfaction beginning at month three and lasting to the end of the evaluation. More than 84% of participants reported they were satisfied with both the natural look and the natural feel of their temples at month 12. Over 90% said they would recommend the treatment to a friend and more than 86% expressed willingness to repeat the procedure. Half of treated participants reported feeling comfortable resuming social activities within 24 hours of their initial treatment.

# Safety and product delivery

The release notes no reports of granulomas or treatment-related serious adverse events in the study cohort. Restylane Volyme is formulated as a flexible gel using Galderma's OBT technology, designed to distribute within tissue to balance facial contours. The company describes a patent-pending dual-layer technique that combines needle and cannula delivery to enable precise, customized placement.

# Trial design specifics

• Design: randomized, evaluator-blinded
• Sample: 162 adults across six sites in China
• Allocation: 2:1 (treatment: untreated control)
• Primary endpoint: one-grade bilateral improvement on the Galderma Temple Volume Deficit Scale at six months

# Regulatory and market context

In the US, the FDA cleared Restylane Contour (the US name for Restylane Volyme) for correction of temple hollowing in adults over age 21 in March 2026. Galderma indicated these China results are intended to support regulatory expansion for the Restylane portfolio in China, a market the company identified as among the fastest-growing in aesthetics.

# What this means for clinicians and patients

For clinicians: the trial provides blinded-evaluator and investigator-assessed evidence that a hyaluronic acid flexible-gel product can produce durable bilateral improvement in temple volume through one year with a high patient-satisfaction profile.

# Bottom line

The study reports a strong efficacy signal and a favorable safety profile for Restylane Volyme in treating temple hollowing in a Chinese clinical population, and Galderma plans to use the data to support broader regulatory indications in China following earlier US clearance.