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- Positive topline results showed that Restylane Volyme (known as Restylane Contour in the U.S.) was highly effective in the correction of moderate-to-severe temple hollowing, with high responder rates maintained through Month 121
- Restylane Volyme was well tolerated, with no incidences of granulomas. Patient and investigator satisfaction were also high1
- These data support Galderma’s aim to expand the availability of the Restylane portfolio in China – a market undergoing significant expansion, and further strengthen Restylane’s vast clinical evidence base2,3
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ZUG, Switzerland — Galderma (SIX: GALD) today announced positive topline results from a study of Restylane Volyme for the correction of moderate-to-severe temple hollowing in 162 patients in China.1 The study met its primary endpoint, demonstrating the effectiveness and safety of Restylane Volyme versus a no-treatment control, while also achieving high patient and investigator satisfaction.1 These data further reinforce Galderma’s ambition to expand its Restylane hyaluronic acid (HA) injectables portfolio in China, one of the world’s fastest-growing aesthetics markets, through evidence generation that supports broader patient access and additional treatment areas.1-3 Powered by diverse NASHA®, NASHA HD™, and OBT™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.1,4-8 Restylane Volyme is a moderately soft and flexible gel made with OBT that distributes within the tissue to offer natural-looking results, helping to soften temple hollowing, restore facial balance, and create a refreshed appearance.1,4,9 With a dual-layer patent-pending technique leveraging both needle and cannula, Restylane Volyme enables healthcare professionals to provide precise, customized, and safe product placement in line with each patient’s aesthetic goals10-12 The volume of the temples can diminish with age, which can disrupt facial balance and harmony, and contribute to a tired, sunken, and aged appearance.12-14 These facial changes can be accelerated in people undergoing medication-driven weight loss, a phenomenon which has increased rapidly in recent years.12-14 Following the launch of Restylane Volyme in China for the treatment of the mid-face region, this study provides new evidence supporting its effectiveness and safety for correction of temple hollowing, in a market where there are currently limited options.1 “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.”
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PROF. ZHAO HONGYI
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STUDY PRINCIPAL INVESTIGATOR,
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DIRECTOR & CHIEF OF THE DEPARTMENT OF PLASTIC SURGERY, BEIJING HOSPITAL, CHINA
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In this randomized, evaluator-blinded study, 162 adults were recruited across six sites in China and were split 2:1 into two groups; the Restylane Volyme treatment group or the no treatment control group.1 Results showed that for patients in the Restylane Volyme group:
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- Strong effectiveness
- 94.4% of patients demonstrated at least 1-grade improvement in temple hollowing, from baseline, in both temples at Month 6 after last treatment, compared to just 2.0% in the control group at Month 6 after baseline.1
- Blinded-evaluator Galderma Temple Volume Deficit Scale responder rates remained high through Month 121
- 91.3% of patients showed improvement on the Global Aesthetic Improvement Scale for both temples through Month 12, according to the treating investigator1
- High satisfaction
- Patient satisfaction was high at Month 3 and remained consistently high, with more than 84% of patients satisfied with both the natural look and natural feel of their temples through Month 121
- More than 90% said they would recommend the treatment to a friend, and over 86% would have the treatment again1
- Half of the participants felt comfortable returning to social engagement within 24 hours after initial treatment1
- Robust safety
- Restylane Volyme was generally well tolerated, with no treatment-related serious adverse events and no granulomas1
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“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.”
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BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
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GLOBAL HEAD OF R&D
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GALDERMA
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With over 30 years of innovation and more than 77 million treatments administered worldwide, the Restylane portfolio offers a versatile range of HA gels that remain highly relevant in responding to today’s most significant aesthetic trends and needs.15-16 China is one of the fastest growing aesthetics markets worldwide and HA fillers are among the top 10 most-sold aesthetics products.2,3 This study highlights Galderma’s commitment to expand the availability of its Restylane portfolio to more patients and practitioners in China and exemplifies its continuing expansion in a growing and strategically significant market.
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