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)--Galderma (SWX:GALD) announces positive first results from a trial designed to explore the benefits of Restylane

)--Galderma（SWX:GALD）宣布了一项旨在探索Restylane益处的试验的初步积极结果

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Lyft™ or Contour™ in combination with Sculptra

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in patients with medication-driven weight loss with associated facial volume loss.

在药物驱动的体重减轻并伴有面部体积减少的患者中。

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Initial three-month interim data from this first-of-its-kind trial suggest that this treatment combination effectively improved facial aesthetic appearance with high patient satisfaction.

这项首次同类试验的最初三个月中期数据表明，这种治疗组合有效改善了面部美学外观，患者满意度高。

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The results will be presented later today at the 43

结果将于今天晚些时候在43

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Annual J.P. Morgan Healthcare Conference in San Francisco, California.

在加利福尼亚州旧金山举行的摩根大通医疗保健年度会议。

Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with facial alterations of variable magnitude.

近年来，药物驱动的体重减轻率迅速增加，并且可能与不同程度的面部改变有关。

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Patients can find that their skin is less radiant, drier or saggy, and can also observe changes in their facial structure and balance.

患者可以发现他们的皮肤不那么容光焕发、干燥或下垂，还可以观察到面部结构和平衡的变化。

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Some even find that they appear older than their age.

有些人甚至发现他们看起来比实际年龄大。

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There are several reasons for these facial alterations including loss of fat, collagen, elastin and essential nutrients such as fatty acids.

这些面部改变有几个原因，包括脂肪，胶原蛋白，弹性蛋白和必需营养素（如脂肪酸）的损失。

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“We initiated this trial because we have the unique expertise, capability, and products needed to rapidly respond to the evolving needs of patients and healthcare professionals. It is encouraging to see these early results, which demonstrate the potential of our existing Injectable Aesthetics portfolio in addressing the effects of medication-driven weight loss on the skin, and we’re looking forward to presenting the nine-month data in due course.”.

“我们启动这项试验是因为我们拥有独特的专业知识、能力和产品，可以快速响应患者和医疗保健专业人员不断变化的需求。看到这些早期结果令人鼓舞，这证明了我们现有的注射美学组合在解决药物驱动的体重减轻对皮肤的影响方面的潜力，我们期待着在适当的时候提供9个月的数据。”。

FLEMMING ØRNSKOV, M.D., MPH

FLEMMENT纸箱，M.D.，MPH

CHIEF EXECUTIVE OFFICER

首席执行官

GALDERMA

硬皮病

Three-month interim data provide response to one of the most predominant aesthetic concerns of patients taking prescription weight loss medicines

In a phase IV clinical trial conducted in the U.S., Galderma investigated the efficacy, safety, and patient satisfaction of Restylane Lyft™ or Contour™ in combination with Sculptra for cheek augmentation and correction of contour deficiencies in patients with medication-driven weight loss with associated facial volume loss..

在美国进行的一项IV期临床试验中，Galderma研究了Restylane Lyft™或Contour™与Sculptra联合用于脸颊增强和矫正药物驱动的体重减轻伴面部体积减少患者的轮廓缺陷的疗效，安全性和患者满意度。。

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Informed by insights gained from pivotal trials of Sculptra and the Restylane portfolio, the trial took place across two sites and used the SHAPE Up Holistic Individualized Treatment (HIT™) as a treatment methodology.

根据从Sculptra和Restylane投资组合的关键试验中获得的见解，该试验在两个地点进行，并使用SHAPE-Up整体个性化治疗（HIT™）作为治疗方法。

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HIT™ is an individualized treatment approach which enables injectors to leverage their expertise with the renowned Galderma Restylane portfolio to optimize aesthetic outcomes while prioritizing patient satisfaction.

HIT™是一种个性化治疗方法，使注射器能够利用其与著名的Galderma Restylane产品组合的专业知识来优化美学效果，同时优先考虑患者满意度。

Patients were treated with Sculptra and either Restylane Lyft™ or Contour™ for their first treatment, a second treatment of Sculptra with an optional touch-up of Restylane Lyft™ or Contour™ at Week 4, and an optional third treatment of Sculptra at Week 8.

患者第一次接受Sculptra和Restylane Lyft™或Contour™治疗，第二次接受Sculptra治疗，第4周可选择对Restylane Lyft™或Contour™进行润色，第8周可选择第三次接受Sculptra治疗。

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Follow-up visits took place at Week 20 for those who received the third Sculptra treatment and at Week 16 for those who did not, corresponding to three months after their final treatment.

接受第三次Sculptra治疗的患者在第20周进行随访，未接受第16周的患者在第16周进行随访，相当于最终治疗后三个月。

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Results at three months demonstrated that the combination of Sculptra and Restylane Lyft™ or Contour™ effectively improved the facial aesthetic appearance of patients experiencing significant medication-driven weight loss with associated facial volume loss, further supporting the benefits of the SHAPE Up HIT™:.

三个月的结果表明，Sculptra和Restylane Lyft™或Contour™的组合有效地改善了经历显着药物驱动的体重减轻并伴有面部体积减少的患者的面部美学外观，进一步支持了SHAPE-Up HIT™的益处。

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Three months after their final treatment, subjects showed improved mid-face shape and contouring along with improvements in cheek wrinkles and an overall improvement in facial appearance

最终治疗三个月后，受试者面部中部形状和轮廓得到改善，脸颊皱纹得到改善，面部外观整体得到改善

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Skin quality findings, which were assessed and reported in the Sculptra/Restylane Lyft™ regimen, demonstrated improvements beyond visual improvement; with Sculptra significantly improving skin radiance and skin thickness three months after final injection treatment

在Sculptra/Restylane Lyft™方案中评估和报告的皮肤质量发现表明，除了视觉改善之外，皮肤质量也有所改善；在最终注射治疗后三个月，Sculptra显着改善皮肤光泽和皮肤厚度

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Additionally, results showed Restylane Lyft™ significantly improved skin hydration as early as Week 4, which was maintained at the three-month follow-up visit

此外，结果显示，早在第4周，Restylane Lyft™就显着改善了皮肤水合作用，这在三个月的随访中得以维持

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Subjects reported high satisfaction as early as four weeks after their first treatment session, which was maintained through to three months after their treatment

受试者早在第一次治疗后四周就报告了很高的满意度，这种满意度一直维持到治疗后三个月

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At Week 4, 85% said their face looked more refreshed, and almost 80% noticed their facial balance was improved, and said the SHAPE Up HIT™ enhanced their face’s structural harmony

在第4周，85%的人说他们的脸看起来更加清爽，近80%的人注意到他们的面部平衡得到了改善，并且说SHAPE Up HIT™增强了他们面部的结构和谐

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89% felt more attractive and happier with their appearance and agreed it provided natural looking results at three months post follow-up

89%的人觉得自己的外表更具吸引力和幸福感，并同意在随访三个月后，它提供了自然的结果

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Safety was in line with previous pivotal trial data for all products, with no treatment-related adverse events reports.

安全性与之前所有产品的关键试验数据一致，没有与治疗相关的不良事件报告。

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“As medication-driven weight loss becomes more prolific around the world, so do the associated impacts of facial volume loss and other unwanted cosmetic effects like shadowing and hollowness. This innovative study is going to be invaluable in exploring how best to address these facial alterations, with results so far being very promising.”.

“随着药物减肥在世界范围内变得越来越多，面部体积减少和其他不必要的美容效果（如阴影和空洞）的相关影响也越来越多。这项创新性研究对于探索如何最好地解决这些面部改变将是非常有价值的，到目前为止，结果非常有希望。”。

MICHAEL SOMENEK, MD

迈克尔·索梅内克，医学博士

CLINICAL TRIAL INVESTIGATOR

临床试验调查员

WASHINGTON DC, UNITED STATES

美国华盛顿特区

Galderma’s broad portfolio addresses key patient and healthcare professional needs

高德玛的广泛投资组合满足了关键患者和医疗保健专业需求

Galderma is well-positioned to address these alterations, given its expertise and experience in dermatology, specialized range of injectable treatments and skincare products, and its patient-centric approach, developed in close collaboration with leading healthcare professionals. While Sculptra - the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation - can help to restore skin integrity, our portfolio of Restylane hyaluronic acid injectables can help refine areas of the face that may have been altered during the weight loss journey..

鉴于高德玛在皮肤病学方面的专业知识和经验，以及与领先的医疗保健专业人员密切合作开发的以患者为中心的方法，高德玛在解决这些变化方面处于有利地位。虽然Sculptra是第一个经过验证的具有独特聚L-乳酸（PLLA-SCA™）配方的再生生物刺激剂，可以帮助恢复皮肤完整性，但我们的Restylane透明质酸注射剂组合可以帮助改善减肥过程中可能改变的面部区域。。

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A six-month extension is now ongoing to confirm the long-term effects, a full nine months after final Sculptra treatment, to further confirm the benefits of the combination approach.

目前正在进行为期六个月的延期，以确认最终Sculptra治疗后整整九个月的长期效果，以进一步确认组合方法的益处。

About the study

关于这项研究

This phase IV trial was a multi-center, open-label study to evaluate the synergistic effects of Restylane

这项IV期试验是一项多中心，开放标签的研究，旨在评估Restylane的协同作用

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Lyft™ or Contour™ in combination with Sculptra

Lyft™或Contour™结合Sculptra

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for cheek augmentation and correction of contour deficiencies, in patients experiencing facial volume loss following treatment with one of four brands of glucagon-like peptide-1 (GLP-1) receptor agonists.

对于用四种品牌的胰高血糖素样肽-1（GLP-1）受体激动剂之一治疗后面部体积减少的患者，用于脸颊增大和轮廓缺陷的矫正。

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Conducted in the U.S., the trial took place across two sites, and used the SHAPE Up Holistic Individualized Treatment (HIT™) as a treatment methodology, with patients treated with Sculptra and either Restylane Lyft™ or Contour™ for their first treatment, a second treatment of Sculptra with an optional touch-up of Restylane Lyft™ or Contour™ at Week 4, and an optional third treatment of Sculptra at Week 8..

该试验在美国进行，在两个地点进行，并使用SHAPE-Up整体个性化治疗（HIT™）作为治疗方法，患者接受Sculptra和Restylane Lyft™或Contour™治疗，第一次治疗，第二次治疗Sculptra，第4周可选择对Restylane Lyft™或Contour™进行润色，第8周可选择第三次治疗Sculptra。。

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Follow-up visits took place at Week 20 for those who received the third Sculptra treatment and at Week 16 for those who did not.

接受第三次Sculptra治疗的患者在第20周进行随访，未接受第16周治疗的患者在第16周进行随访。

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Skin quality findings were assessed in the Sculptra/Restylane Lyft™ regimen.

在Sculptra/Restylane Lyft™方案中评估了皮肤质量发现。

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About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

Galderma（六：GALD）是纯粹的皮肤病学类别的领导者，目前在大约90个国家/地区。我们通过注射美学、皮肤科皮肤护理和治疗性皮肤病学，提供创新、科学的优质旗舰品牌和服务组合，涵盖快速增长的皮肤病学市场的所有领域。

Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story.

自1981年成立以来，我们一直专注于人体最大的器官-皮肤-与医疗保健专业人员合作，以优异的效果满足个人消费者和患者的需求。因为我们了解我们所处的皮肤塑造了我们的生活，所以我们正在为每一个皮肤故事推进皮肤病学。

For more information: .

有关详细信息：。

www.galderma.com

www.galderma.com

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References

参考文献

Galderma. Data on file. Somenek M and Lorenc P. A multi-center, open-label study to evaluate the synergistic effects of biostimulator and dermal fillers for cheek augmentation and correction of contour deficiencies.

高德玛。文件中的数据。Somenek M和Lorenc P.一项多中心开放标签研究，旨在评估生物刺激剂和皮肤填充剂对脸颊增大和轮廓缺陷矫正的协同作用。

Mansour MR, et al. The rise of “Ozempic Face”: Analyzing trends and treatment challenges associated with rapid facial weight loss induced by GLP-1 agonists.

Mansour MR等人，“Ozempic脸”的兴起：分析GLP-1激动剂引起的面部快速减肥的趋势和治疗挑战。

JPRAS

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2024年；96:225-227。两个： 10.1016/j.bjps.2024.07.051

Tay JQ. Ozempic face: A new challenge for facial plastic surgeons.

泰伊JQ。臭脸：面部整形外科医生面临的新挑战。

JPRAS

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2023年；81:97-98。两个： 10.1016/j.bjps.2023.04.057

Humphrey CD and Lawrence AC. Implications of Ozempic and other GLP-1 receptor agonists for facial plastic surgeons.

Humphrey CD和Lawrence AC.臭氧和其他GLP-1受体激动剂对面部整形外科医生的影响。

Facial Plast Surg

面部整形外科

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Sculptra

雕塑

®

®

. EU Instructions for Use. 2021. Available

.欧盟使用说明。2021年。可用

online

在线

. Accessed January 2025

.2025年1月访问

Widgerow A, et al. A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress, February 1-3, 2024, Paris, France

Widgerow A等人，一项描述聚L-乳酸（PLLA-SCA）和羟基磷灰石钙（CaHA）治疗鼻唇沟的基因特征的随机比较研究。2024年2月1日至3日在法国巴黎举行的IMCAS世界大会上发布的海报

Galderma. Data on File (MA-60875)

一个问题数据文件 (MA-60875)

Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres.

张毅，等。体内诱导生物可降解聚合物微球的胶原再生。

Regen Biomater

雨生物母

. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042

2021年；8（5）：rbab042。两个： 10.1093/rb/rbab042

Huth S, et al. Molecular Insights into the effects of PLLA_SCA on Gene Expression.

Huth S等人。PLLA\u SCA对基因表达影响的分子见解。

J Drugs Dermatol

J药物皮肤病

. 2024;23(4):285-288. doi: 10.36849/JDD.779

2024年；23（4）：285-288。两个： 10.36849/JDD.779