JPWO2021245223A5 - - Google Patents

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JPWO2021245223A5
JPWO2021245223A5 JP2022573504A JP2022573504A JPWO2021245223A5 JP WO2021245223 A5 JPWO2021245223 A5 JP WO2021245223A5 JP 2022573504 A JP2022573504 A JP 2022573504A JP 2022573504 A JP2022573504 A JP 2022573504A JP WO2021245223 A5 JPWO2021245223 A5 JP WO2021245223A5
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botulinum toxin
lines
injection
injected
botulinum
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JP2022573504A
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JP2023529095A (en
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Priority claimed from PCT/EP2021/064986 external-priority patent/WO2021245223A1/en
Publication of JP2023529095A publication Critical patent/JP2023529095A/en
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Claims (14)

対象の顔面領域に注射して顔のシワを治療するための総計で50U~200Uの用量及び総計で0.05ml~0.35mlの体積のボツリヌス毒素注射剤。 A botulinum toxin injection in a total dose of 50 U to 200 U and a total volume of 0.05 ml to 0.35 ml for injection into the facial area of a subject to treat facial wrinkles. 総計で50U~175U、又は60U~150U、又は70U~125U、又は75U~100Uの用量で前記ボツリヌス毒素が注射される、請求項1に記載のボツリヌス毒素注射剤。 10. The botulinum toxin injection of claim 1, wherein the botulinum toxin is injected in a total dose of 50U to 175U, or 60U to 150U, or 70U to 125U, or 75U to 100U. 総計で0.10ml~0.35ml、又は0.10ml~0.30ml、又は0.15ml~0.35ml、又は0.15ml~0.30mlの体積で前記ボツリヌス毒素が注射される、請求項1又は2に記載のボツリヌス毒素注射剤。 3. The botulinum toxin injection of claim 1 or 2, wherein the botulinum toxin is injected in a total volume of 0.10 ml to 0.35 ml, or 0.10 ml to 0.30 ml, or 0.15 ml to 0.35 ml, or 0.15 ml to 0.30 ml. 150U/ml~2000U/ml、又は200U/ml~1500U/ml、又は250U/ml~1000U/ml、又は300U/ml~800U/ml、又は350U/ml~600U/mlの濃度で前記ボツリヌス毒素が注射される、請求項1から3のいずれか1項に記載のボツリヌス毒素注射剤。 4. The botulinum toxin injection of claim 1, wherein the botulinum toxin is injected at a concentration of 150 U/ml to 2000 U/ml, or 200 U/ml to 1500 U/ml, or 250 U/ml to 1000 U/ml, or 300 U/ml to 800 U/ml, or 350 U/ml to 600 U/ml . 3か所~8か所の注射点で前記ボツリヌス毒素が注射され、及び/又は各注射点に6U~50Uの用量で前記ボツリヌス毒素が注射される、請求項1から4のいずれか1項に記載のボツリヌス毒素注射剤。 5. The botulinum toxin injection of claim 1, wherein the botulinum toxin is injected at 3 to 8 injection points and/or each injection point is injected at a dose of 6 U to 50 U. 各注射部位に0.02ml~0.14ml、又は0.03ml~0.10ml、又は0.04ml~0.06mlの体積で前記ボツリヌス毒素が注射される、請求項5に記載のボツリヌス毒素注射剤。 6. The botulinum toxin injection of claim 5, wherein the botulinum toxin is injected at each injection site in a volume of 0.02 ml to 0.14 ml, or 0.03 ml to 0.10 ml, or 0.04 ml to 0.06 ml. 前記ボツリヌス毒素が額の横ジワ、眉間の表情ジワ、目元のシワ、目尻のシワ、鼻柱のシワ、ほうれい線、上唇のシワ、下唇のシワ、口角周囲のシワ、マリオネットライン、口元のシワ、口角、頤唇溝及び顎の梅干しジワの治療、特に額の横ジワ、眉間の表情ジワ、並びに目尻のシワを含む目元のシワの治療に使用される、請求項1から6のいずれか1項に記載のボツリヌス毒素注射剤。 7. The botulinum toxin injection preparation according to claim 1, wherein the botulinum toxin is used for treating horizontal lines on the forehead, lines between the glabellar glabellars, lines around the eyes, lines at the crow's feet, lines on the bridge of the nose, nasolabial folds, lines on the upper lip, lines on the lower lip, lines around the corners of the mouth, marionette lines, lines around the mouth, lines at the corners of the mouth, menthol-labial folds and lines on the chin, in particular for treating horizontal lines on the forehead, lines between the glabellar glabellars and lines around the eyes including lines at the crow's feet. 前記対象が、最大限顔をしかめた際に調査者が顔面シワ尺度(FWS)を用いてした評価に基づく中等度若しくは重度の眉間の表情ジワを有する又は重度の眉間の表情ジワを有する対象である、請求項1から7のいずれか1項に記載のボツリヌス毒素注射剤。 8. The botulinum toxin injection preparation of claim 1, wherein the subject has moderate or severe glabellar lines or severe glabellar lines based on an investigator's assessment using the Facial Wrinkle Scale (FWS) when frowning to the maximum. 前記対象が女性の対象である、請求項1から8のいずれか1項に記載のボツリヌス毒素注射剤。 9. The botulinum toxin injection of claim 1, wherein the subject is a female subject. 前記ボツリヌス毒素が眉間の表情ジワの治療に使用され、且つ、総計で50U~150Uの用量及び総計で0.15ml~0.35mlの体積の前記ボツリヌス毒素が4点、5点、又は6点の筋肉内注射点に注射される、請求項1から9のいずれか1項に記載のボツリヌス毒素注射剤。 10. The botulinum toxin injection of claim 1, wherein the botulinum toxin is used to treat glabellar lines, and a total dose of 50 U to 150 U and a total volume of 0.15 ml to 0.35 ml of the botulinum toxin is injected into 4, 5, or 6 intramuscular injection points . 前記ボツリヌス神経毒が、最大限顔をしかめた際に調査者が顔面シワ尺度(FWS)を用いてした評価に基づく中等度若しくは重度の眉間の表情ジワ又は重度の眉間の表情ジワの治療に使用され、且つ、(i)総計で70U~130Uの用量及び総計で0.15ml~0.35mlの体積、又は(ii)総計で80U~120Uの用量及び総計で0.15ml~0.25mlの体積で前記ボツリヌス毒素が注射される、請求項10に記載のボツリヌス毒素注射剤。 11. The botulinum toxin injection of claim 10, wherein the botulinum neurotoxin is used to treat moderate or severe glabellar lines or severe glabellar lines as assessed by an investigator using the Facial Wrinkle Scale (FWS) during maximum frown, and the botulinum toxin is injected at (i) a total dose of 70 U to 130 U and a total volume of 0.15 ml to 0.35 ml, or (ii) a total dose of 80 U to 120 U and a total volume of 0.15 ml to 0.25 ml . 前記ボツリヌス毒素が、ボツリヌス神経毒複合体又はボツリヌス神経毒複合体の神経毒成分であり、前記神経毒成分が前記ボツリヌス菌(Clostridium botulinum)神経毒複合体の他のあらゆるタンパク質成分を欠いており、好ましくは前記ボツリヌス毒素が血清型Aのボツリヌス毒素である、請求項1から11のいずれか1項に記載のボツリヌス毒素注射剤。 12. The botulinum toxin injection of claim 1, wherein the botulinum toxin is a botulinum neurotoxin complex or a neurotoxic component of a botulinum neurotoxin complex, the neurotoxic component being devoid of any other protein components of the Clostridium botulinum neurotoxin complex, and preferably the botulinum toxin is a botulinum toxin of serotype A. 前記ボツリヌス毒素が2回の連続する治療セッションの間に6~9か月の間隔を空けて投与される、請求項1から12のいずれか1項に記載のボツリヌス毒素注射剤。 13. The botulinum toxin injection preparation of any one of claims 1 to 12, wherein the botulinum toxin is administered with an interval of 6 to 9 months between two successive treatment sessions. 対象の顔面領域に注射して顔のシワを治療するための前記顔のシワを治療するために総計で50U~200Uの用量及び総計で0.05ml~0.35mlの体積のボツリヌス毒素含む、組成物。 A composition comprising a botulinum toxin for injection into a facial area of a subject to treat facial wrinkles , the composition comprising a total dose of 50 U to 200 U and a total volume of 0.05 ml to 0.35 ml to treat said facial wrinkles.
JP2022573504A 2020-06-05 2021-06-04 Treatment of facial wrinkles with high-dose, low-volume botulinum toxin Pending JP2023529095A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20178574.8 2020-06-05
EP20178574 2020-06-05
PCT/EP2021/064986 WO2021245223A1 (en) 2020-06-05 2021-06-04 High dose and low volume botulinum toxin treatment of facial wrinkles

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JP2023529095A JP2023529095A (en) 2023-07-07
JPWO2021245223A5 true JPWO2021245223A5 (en) 2024-06-03

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US (1) US20230329996A1 (en)
EP (1) EP4161562A1 (en)
JP (1) JP2023529095A (en)
KR (1) KR20230020961A (en)
CN (1) CN115666629A (en)
AU (1) AU2021286196A1 (en)
BR (1) BR112022023413A2 (en)
CA (1) CA3177835A1 (en)
IL (1) IL298399A (en)
MX (1) MX2022014564A (en)
TW (1) TW202214211A (en)
WO (1) WO2021245223A1 (en)

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WO2023186016A1 (en) * 2022-04-01 2023-10-05 重庆誉颜制药有限公司 Botulinum toxin protein composition, method for preparing same, and use thereof
WO2024115413A1 (en) * 2022-11-28 2024-06-06 Merz Pharma Gmbh & Co. Kgaa High concentration botulinum toxin treatment for neck rejuvenation

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DE19925739A1 (en) 1999-06-07 2000-12-21 Biotecon Ges Fuer Biotechnologische Entwicklung & Consulting Mbh Therapeutic with a botulinum neurotoxin
US7691394B2 (en) * 2002-05-28 2010-04-06 Botulinum Toxin Research Associates, Inc. High-potency botulinum toxin formulations
DE10333317A1 (en) 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulation for protein medicines without the addition of human serum albumin (HSA)
AU2005274822B2 (en) 2004-07-26 2008-10-30 Merz Pharma Gmbh & Co. Kgaa Therapeutic composition with a botulinum neurotoxin
EP2271670B1 (en) 2008-03-14 2014-09-03 Allergan, Inc. Immuno-based botulinum toxin serotype a activity assays
CN103958747B (en) 2011-09-29 2017-03-01 塞尔斯纳普有限责任公司 Compositionss for toxigenicity test and method
CA2913686C (en) 2013-06-28 2021-08-03 Merz Pharma Gmbh & Co. Kgaa Means and methods for the determination of the biological activity of neurotoxin polypeptides in cells
MX2020005785A (en) * 2017-12-04 2020-10-28 Revance Therapeutics Inc Injectable botulinum toxin formulations and methods of use thereof having high response rate and long effect duration.

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