JP5775658B2 - セルライト処置用コラゲナーゼ - Google Patents
セルライト処置用コラゲナーゼ Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
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- A61P3/00—Drugs for disorders of the metabolism
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- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/06—Preparations for care of the skin for countering cellulitis
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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Description
本願は、2006年2月22日に米国特許商標庁に出願された出願番号60/775,690号に対して優先権を主張する。
本発明は、国立衛生研究所からの助成金M01RR10710によって、一部支持された。米国政府は、本発明に対して一定の権利を有する。
大腿部および臀部の皮膚の陥凹形成、すなわち「マットレス現象」は、一般的にセルライトといわれる。この状態は共通であり、そうでなければ健康な個体に現れ、男性よりはるかに高い頻度で女性が罹患する。セルライト除去のための、処方箋が不要な局所療法が多くある。これらの製品および処方箋が不要な局所への適用は、役に立たず、費用がかかり、実際に、適切なプラセボコントロールされた臨床試験を経たことがない。局所レチノールならびにカフェインおよびルスコゲニン(ruscogenine)を含むレチノールの、最近のランダム化されたプラセボコントロールされた試験(trail)はまた、セルライトの除去に関する価値を示せなかった。
本発明は、コラゲナーゼ注射が、ヒトのセルライトのコラーゲンセプタエネットワークを溶解し、セルライトを処置し、および平坦な皮膚の外観を回復するのに有効であるという発見に関する。本発明は、処置を必要とする被験体においてセルライトを処置する方法に関し、該方法は、セルライトを処置するための医薬の製造において有効量の精製されたコラゲナーゼを注入する工程を含む。コラゲナーゼは、好ましくは、精製されており、プロテアーゼおよび/またはヒアルロニダーゼ等の他の酵素を実質的に含まない。
本発明は、コラゲナーゼ注射が、ヒトのセルライトのコラーゲンセプタエネットワークを溶解し、セルライトを処置し、および平坦な皮膚の外観を回復するのに有効であるという発見に関する。本発明は、処置を必要とする被験体においてセルライトを処置する方法に関し、該方法は、大腿部および/または臀部に有効量のコラゲナーゼを注入する工程を含む。本発明はまた、セルライトを処置するための医薬の製造におけるコラゲナーゼの使用に関する。
切断されるペプチド結合の数は、ニンヒドリンとの反応によって測定される。可溶化消化コントロールによって放出されるアミノ基は、減算される。正味の1ABC単位のコラゲナーゼは、1分あたり1.09ナノモルのロイシンに等価なニンヒドリン反応性物質を可溶化する。1SRC単位は、約6.3ABC単位と等しい。
方法
十名の患者が研究プロトコールに参加した。全てが女性で、平均年齢は41歳=10歳。平均ボディマス指数(BMI)は28であった。
全ての患者が、コラゲナーゼの注入後に標的大腿部のセルライトの減少を体験した。表1は、処置された患者の大腿部の四半部におけるセルライトが減少するという結果を示す。注入された領域(are)のセルライトの出現の有意な減少があった。セルライト領域(are)は、1日目までにベースラインと比較して77%減少した。この結果はより長期間維持された。ベースラインと比較して、セルライトの領域は1週間で74%、1ヶ月で89%、3ヶ月で86%、そして6ヶ月で76%減少した。
Claims (12)
- 治療を必要としている被験体においてセルライトを治療するための医薬の製造における、精製されたコラゲナーゼの使用であって、該医薬は、セルライトのコラーゲン性隔壁ネットワーク(collagenous septa network)に投与され、該コラゲナーゼは、他の酵素を含まず、精製されたコラゲナーゼが、単回処置当たり少なくとも10,000ABC単位を含む用量で、一回以上の注射で投与される、使用。
- コラゲナーゼ(クロストリジオペプチダーゼA)が、細菌クロストリジウム・ヒストリチカム(Clostridium histolyticum)に由来する、請求項1記載の使用。
- 精製されたコラゲナーゼが単独で投与される、請求項1記載の使用。
- 精製されたコラゲナーゼが、トリアムシノロンまたは他のコルチコステロイドの非存在下で投与される、請求項1記載の使用。
- 精製されたコラゲナーゼが、1.0mLの体積で注射される、請求項1記載の使用。
- 精製されたコラゲナーゼが複数の部位に注射される、請求項1記載の使用。
- 精製されたコラゲナーゼが、コラゲナーゼIおよびコラゲナーゼIIで構成される、請求項1記載の使用。
- 注射が、皮膚の陥凹形成を特徴とするセルライトの領域に送達される、請求項5記載の使用。
- 被験体がヒト患者である、請求項1記載の使用。
- 治療が4〜6週間後に繰り返される、請求項1記載の使用。
- コラゲナーゼの少なくとも一回の投与を受けた1ヵ月後に、被験体はセルライトの外見に目視による有意な減少を達成する、請求項1記載の使用。
- 精製されたコラゲナーゼが、500SRC単位/mg〜15,000SRC単位/mgの比活性を有し、該コラゲナーゼは、一回以上の注射で投与される、請求項1記載の使用。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US77569006P | 2006-02-22 | 2006-02-22 | |
US60/775,690 | 2006-02-22 | ||
US11/703,269 | 2007-02-07 | ||
US11/703,269 US20070224184A1 (en) | 2006-02-22 | 2007-02-07 | Method for treating cellulite |
PCT/US2007/004752 WO2007100675A2 (en) | 2006-02-22 | 2007-02-22 | Collagenase for treating cellulite |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015095704A Division JP2015134840A (ja) | 2006-02-22 | 2015-05-08 | セルライト処置用コラゲナーゼ |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2009527570A JP2009527570A (ja) | 2009-07-30 |
JP5775658B2 true JP5775658B2 (ja) | 2015-09-09 |
Family
ID=38325147
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US6958150B2 (en) | 1994-12-15 | 2005-10-25 | Advance Biofactures Of Curacao, N.V. | Reduction of adipose tissue |
US20070224184A1 (en) * | 2006-02-22 | 2007-09-27 | The Research Foundation Of The State University Of New York | Method for treating cellulite |
JP4967081B2 (ja) * | 2005-01-21 | 2012-07-04 | ザ リサーチ ファウンデーション オブ ステート ユニバーシティ オブ ニューヨーク | 癒着性関節包炎の処置方法 |
US20090233885A1 (en) * | 2006-07-14 | 2009-09-17 | Duncan Diane I | Compositions and Methods for Fat Reduction |
US10071143B1 (en) | 2007-05-03 | 2018-09-11 | The Research Foundation For The State University Of New York | Methods for non-surgical treatment of carpal tunnel syndrome |
TWI395593B (zh) | 2008-03-06 | 2013-05-11 | Halozyme Inc | 可活化的基質降解酵素之活體內暫時性控制 |
CA2754461A1 (en) * | 2009-03-06 | 2010-09-10 | Halozyme, Inc. | Temperature sensitive mutants of matrix metalloprotease 1 and uses thereof |
JP5284239B2 (ja) * | 2009-10-07 | 2013-09-11 | 株式会社メタコ | スクリーン装置 |
FR2966734B1 (fr) * | 2010-10-29 | 2014-07-18 | Max Rombi | Composition comprenant au moins une enzyme proteolytique pour son utilisation pour empecher la synthese des triglycerides |
JP2014530873A (ja) * | 2011-10-21 | 2014-11-20 | オーキシリウム インターナショナル ホールディングス,インコーポレイテッド | Efpの治療または低減方法 |
HUE046160T2 (hu) | 2012-01-12 | 2020-02-28 | Endo Global Ventures | Clostridium histolyticum enzim |
WO2014066622A2 (en) | 2012-10-24 | 2014-05-01 | The Research Foundation For The State University Of New York | Use of collagenase to treat glaucoma |
WO2014107745A1 (en) | 2013-01-07 | 2014-07-10 | Halozyme, Inc. | Metal sensitive mutants of matrix metalloproteases and uses thereof |
DK2968484T3 (da) | 2013-03-15 | 2021-02-22 | Biospecifics Tech Corporation | Behandlingsfremgangsmåde og produkt til uterus fibromer, som anvender oprenset kollagenase |
US10117892B2 (en) | 2013-08-29 | 2018-11-06 | Allergan, Inc. | Devices and methods for reducing the appearance of cellulite |
CN103751102A (zh) | 2014-01-15 | 2014-04-30 | 上海交通大学 | 一种胶原酶温敏水凝胶及其制备方法和应用 |
JP2020511284A (ja) * | 2017-03-01 | 2020-04-16 | エンド ベンチャーズ リミテッド | セルライトを評価及び処置するための装置及び方法 |
US11473074B2 (en) | 2017-03-28 | 2022-10-18 | Endo Global Aesthetics Limited | Method of producing collagenase |
WO2020021330A2 (en) * | 2018-07-12 | 2020-01-30 | Endo Global Aesthetics Limited | Injection techniques for the treatment of cellulite |
WO2020021332A2 (en) * | 2018-07-12 | 2020-01-30 | Endo Global Aesthetics Limited | Injection techniques for the treatment of cellulite |
AU2019341663A1 (en) * | 2018-09-18 | 2021-04-22 | Endo Global Aesthetics Limited | Compositions and methods for treating cellulite |
KR20210113271A (ko) * | 2019-01-06 | 2021-09-15 | 엔도 글로벌 에스테틱스 리미티드 | 콜라게나제 제형 및 이의 제조 방법 |
AU2020366008A1 (en) | 2019-10-15 | 2022-06-02 | Biospecifics Technologies Corp. | Treatment of uterine fibroids using purified collagenase |
BR112022010042A2 (pt) * | 2019-11-26 | 2022-08-16 | Standard Of Care Corp | Composições de hialuronidase e métodos de uso da mesma para tratar celulite |
WO2023218384A1 (en) * | 2022-05-10 | 2023-11-16 | Endo Global Aesthetics Limited | Methods of reducing collagenase-mediated bruising in a subject having cellulite |
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US4338300A (en) * | 1981-02-05 | 1982-07-06 | The Regents Of The University Of California | Use of purified clostridial collangenase in the treatment of Peyronie's disease |
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US5393792A (en) * | 1991-11-20 | 1995-02-28 | Advance Biofactures Of Curacao, N.V. | High dosage topical forms of collagenase |
US5332503A (en) * | 1993-04-16 | 1994-07-26 | Baxter International Inc. | Process for purifying collagenase |
WO1996000283A1 (en) * | 1994-06-24 | 1996-01-04 | Boehringer Mannheim Corporation | A purified mixture of collagenases and two other proteases obtained from clostridium histolyticum |
US5589171A (en) * | 1994-08-22 | 1996-12-31 | Advance Biofactures Of Curacao | Treatment of Dupuytren's disease with collagenase |
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US5830741A (en) * | 1996-12-06 | 1998-11-03 | Boehringer Mannheim Corporation | Composition for tissue dissociation containing collagenase I and II from clostridium histolyticum and a neutral protease |
US6086872A (en) * | 1997-03-27 | 2000-07-11 | Advance Biofactures Of Curacao, Nv | Amelioration of dupuytren's disease |
CA2317066A1 (en) * | 1997-10-03 | 1999-04-15 | Lavipharm Laboratories, Inc. | A prolamine-plant polar lipid composition, its method of preparation and applications thereof |
US6022539A (en) * | 1999-06-03 | 2000-02-08 | Advance Biofactures Of Curacao | Amelioration of peyronie's disease |
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JP4967081B2 (ja) * | 2005-01-21 | 2012-07-04 | ザ リサーチ ファウンデーション オブ ステート ユニバーシティ オブ ニューヨーク | 癒着性関節包炎の処置方法 |
US20070224184A1 (en) * | 2006-02-22 | 2007-09-27 | The Research Foundation Of The State University Of New York | Method for treating cellulite |
US7811560B2 (en) * | 2006-01-30 | 2010-10-12 | Auxilium Us Holdings, Llc | Compositions and methods for treating collagen-mediated diseases |
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