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澳大利亚轮廓研究:颏下丰满状况及使用Belkyra的治疗结果登记研究

CONTOUR Australia: Condition of Submental Fullness and Treatment Outcomes with Belkyra Registry.

作者信息

Boxley Sarah G, Lin Frank, Lee See Neville, St Rose Suzanne, Battucci Simona, Simonyi Susan

机构信息

From SkinBox Clinics, Perth, WA, Australia.

Eastern Plastic Surgery, Box Hill North, VIC, Australia.

出版信息

Plast Reconstr Surg Glob Open. 2023 Jul 18;11(7):e5123. doi: 10.1097/GOX.0000000000005123. eCollection 2023 Jul.

DOI:10.1097/GOX.0000000000005123
PMID:37469476
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10353711/
Abstract

UNLABELLED

Submental fat (SMF) contributes to an aged or overweight appearance that may negatively impact an individual's psychological well-being. Deoxycholic acid (ATX-101) is an injectable formulation of deoxycholic acid approved to treat SMF. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) Australia study was designed to understand treatment patterns and outcomes with ATX-101 in Australia.

METHODS

CONTOUR Australia was a phase 4, prospective, observational, multicenter registry that enrolled adults considering treatment for SMF reduction.

RESULTS

The registry enrolled 86 patients from six sites. Significant changes from baseline through the end of treatment indicated improvement in mild to moderate fullness associated with SMF on the Clinician-Reported SMF Rating Scale and the Patient-Reported SMF Rating Scale, improvement in SMF-associated psychological impact after treatment on the Patient-Reported SMF Impact Scale, no overall worsening in skin laxity based on Submental Skin Laxity Grade, and increased patient satisfaction with the face/chin on the Subject Self-Rating Scale after receiving treatment. Adverse events were all mild and mostly related to the injection site (ie, bruising and swelling).

CONCLUSION

CONTOUR Australia observed clinically meaningful and significant outcomes and further supports ATX-101 as a well-tolerated and effective treatment for SMF reduction.

摘要

未标注

颏下脂肪(SMF)会导致人显得衰老或超重,可能对个人心理健康产生负面影响。脱氧胆酸(ATX-101)是一种已获批准用于治疗颏下脂肪的可注射脱氧胆酸制剂。澳大利亚颏下丰满状况与治疗结果登记研究(CONTOUR)旨在了解ATX-101在澳大利亚的治疗模式和效果。

方法

澳大利亚CONTOUR研究是一项4期前瞻性观察性多中心登记研究,纳入了考虑接受减少颏下脂肪治疗的成年人。

结果

该登记研究从6个地点招募了86名患者。从基线到治疗结束的显著变化表明,在临床医生报告的SMF评分量表和患者报告的SMF评分量表上,与SMF相关的轻至中度丰满度有所改善;在患者报告的SMF影响量表上,治疗后与SMF相关的心理影响有所改善;根据颏下皮肤松弛分级,皮肤松弛度总体没有恶化;在接受治疗后,患者在主观自评量表上对脸部/下巴的满意度有所提高。不良事件均为轻度,主要与注射部位有关(即瘀伤和肿胀)。

结论

澳大利亚CONTOUR研究观察到了具有临床意义的显著结果,进一步支持ATX-101作为一种耐受性良好且有效的减少颏下脂肪的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/d6c73337a1dc/gox-11-e5123-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/b15c021c849a/gox-11-e5123-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/a52f83b3226f/gox-11-e5123-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/0b4931589e77/gox-11-e5123-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/3848f994e539/gox-11-e5123-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/d6c73337a1dc/gox-11-e5123-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/b15c021c849a/gox-11-e5123-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/a52f83b3226f/gox-11-e5123-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/0b4931589e77/gox-11-e5123-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/3848f994e539/gox-11-e5123-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1322/10353711/d6c73337a1dc/gox-11-e5123-g005.jpg

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本文引用的文献

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Aesthet Surg J. 2021 Sep 14;41(10):1107-1119. doi: 10.1093/asj/sjaa339.
2
Development and Validation of the Patient-Reported Submental Fat Rating Scale and the Patient-Reported Submental Fat Impact Scale.患者报告颏下脂肪分级量表和患者报告颏下脂肪影响量表的制定与验证。
Dermatol Surg. 2021 Apr 1;47(4):522-525. doi: 10.1097/DSS.0000000000002908.
3
ATX-101 (Deoxycholic Acid Injection) Leads to Clinically Meaningful Improvement in Submental Fat: Final Data From CONTOUR.
ATX-101(脱氧胆酸注射剂)可显著改善颏下脂肪:CONTOUR 的最终数据。
Dermatol Surg. 2020 May;46(5):639-645. doi: 10.1097/DSS.0000000000002092.
4
Histological Analysis of the Effect of ATX-101 (Deoxycholic Acid Injection) on Subcutaneous Fat: Results From a Phase 1 Open-Label Study.ATX-101(脱氧胆酸注射液)对皮下脂肪影响的组织学分析:一项 1 期开放标签研究结果。
Dermatol Surg. 2020 Jan;46(1):70-77. doi: 10.1097/DSS.0000000000001851.
5
Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR).颏下丰满状况与治疗结果登记处(CONTOUR)的最终数据。
J Drugs Dermatol. 2019 Jan 1;18(1):40-48.
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Personal (Self) Perceptions of Submental Fat Among Adults in the United States.美国成年人对颏下脂肪的个人(自我)认知。
Dermatol Surg. 2019 Jan;45(1):124-130. doi: 10.1097/DSS.0000000000001648.
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