JP2016539987A - 剥脱性の毛髪保持促進製剤 - Google Patents
剥脱性の毛髪保持促進製剤 Download PDFInfo
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- JP2016539987A JP2016539987A JP2016538005A JP2016538005A JP2016539987A JP 2016539987 A JP2016539987 A JP 2016539987A JP 2016538005 A JP2016538005 A JP 2016538005A JP 2016538005 A JP2016538005 A JP 2016538005A JP 2016539987 A JP2016539987 A JP 2016539987A
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Abstract
Description
本出願は、2013年12月13日に出願された米国仮出願第61/915,988号の優先権の利益を主張するものであり、その内容は、参照により本明細書に援用される。
本発明は、概して、毛髪保持を促進するための製剤に関し、具体的には、毛包健康促進剤のより効率的な使用を提供するための、製剤およびその使用のためのプロセスに関する。
特定の理論に拘束されることを意図せずに、機械的表皮剥脱または化学的ピーリングと関連する剥脱は、頭皮に炎症を生じさせ、それは本発明の剥脱と関連する利益の多くを打ち消すと考えられる。化学的ピーリングの剥脱は、グリコール酸およびレチノイン酸を例示的に含む化合物の使用と関連することが最も多い。その代わりに、本発明は、毛髪保持促進物質が毛髪繊維の周辺を乳頭へ浸透するのを可能にする酵素的な頭皮剥脱剤に依存している。剥脱と関連する炎症の制限は、毛髪保持促進物質の有効性を促進すると考えられる。
本明細書において値の範囲が与えられる場合は、その範囲は、その範囲の末端値だけではなく、その範囲内の個々の中間値および中間範囲も含むことを意図することが理解される。例として、1〜4の例示範囲は、1〜4だけではなく、1、2、3、4、1〜2、1〜3、2〜4、および3〜4も含むことを意図する。
脱イオン水の水溶液において、頭皮活性化処置を形成するためのプロセスが5ステップで提供される。ステップAでは、クエン酸、クエン酸ナトリウム、およびアスコルビン酸グルコシドを、その順番で主容器内の脱イオン水へ、次の成分を添加する前に各成分が混和されるまで水と混合しながら添加する。ステップBでは、水酸化ナトリウム(NaOH)(20%)を添加して、主容器内の第一の混合物のpHを6.5〜6.8に調節する。ステップCでは、グルコシルヘスペリジンおよび紅参抽出物(40重量%の水、60重量%のブチレングリコールおよび0.2重量%のオタネニンジン根抽出物)を主容器へ添加して、全ての固形物が溶解して均一に混和するまで混合する。ステップDでは、1,2−ヘキサンジオール、ペンチレングリコール、および、カプリル/カプリントリグリセリド溶媒中の褐藻類抽出物(抽出物は、100グラムの溶媒和抽出物あたり:パルミチン酸28.2mg、パルミトレイン酸12.4mg、ステアリン酸6.8mg、オレイン酸14.7mg、リノール酸−(オメガ6)7.2mg、リノレン酸9.7mg、オメガ3脂肪酸26.3mg、コレステロール47.2mg、カンペステロール45.9mg、スチグマステロール57.5mg、およびシトステロール142.8mgを含む)が、別容器内で予め混合されてから主容器へ添加されて、混和するまで混合される。ステップEでは、ロイコレクチン(単数または複数)または他のレクチン類、コリオリシン(単数または複数)、およびゾナーゼ(0.00068重量%のロイコレクチン含有量、0.00034重量%のゾナーゼ含有量、0.0000136重量%のコリオリシン含有量)を含む、サケ卵孵化酵素溶液が、主容器へ添加されて混和するまで混合され、最終製剤を形成する。表3は前述の成分をリスト化し、%は総重量%である。
実施例1のプロセスを、溶液中にビタミンB3、B5、B6、CおよびEを含むビタミン複合体を追加して繰り返す。追加されるビタミン複合体溶液の量は、最終総重量の2%であり、脱イオン水の量が対応して減少する。ビタミン類は、100グラムのビタミン複合体溶液あたり、10〜200ミリグラムの変動量で、ビタミン複合体溶液中に存在する。
排水トラップの収集により測定して1日あたり平均52本の毛髪の日々の脱毛に悩む女性対象が、実施例1の製剤の使用を開始した(毎日、日常のシャンプーおよびコンディショナーの使用後に1ミリリットルの溶液を用いて頭にエアロゾルをミストし、その後に、ブロー乾燥の前に5分の休止時間を置く)。毎日使用を8週間した後、日々の脱毛は1日あたり平均4.6本の毛髪に減少した。
実施例3の方法を実施例2の製剤を用いて繰り返すと、1日あたり平均3.4本の毛髪の日々の脱毛をもたらす。
製剤からグルコシルヘスペリジンを省略するが、実施例1の方法を繰り返す。日々の脱毛の減少は、実施例3のものと一致することが示される。
実施例1の製剤を用いて、臨床試験を行なった。以下を含む登録基準で対象を募集した:対象は年齢が25〜55才の女性であり;対象は標準的にシャンプーおよびコンディショナーを使用し;対象はコスメトロジストにより判定される評価に十分な毛髪の長さを有し;皮膚タイプI〜IVであり(白色から、「常に日焼けしている」〜「日焼けしやすい」までの範囲内で太陽に対する皮膚反応による適度に茶色までの範囲);対象は、ベースライン評価において、少なくとも20本の毛髪が抜け落ち;対象は、調整段階および試験持続の間、通常のヘアシャンプーおよびコンディショナーを提供される物質と置き換えることに同意し;対象は、試験持続の間、与えられる頭皮処置を一日おきに1回適用することに同意し;対象は、太陽曝露から頭皮を保護することに同意し;対象は一般に健康良好であり;および、対象は信頼でき、プロトコルに概説される指示に従うことが可能である。
MEDISCOPE(登録商標)は、高解像度のデジタル写真を、ソフトウェアアーカイビングシステムのダイレクトキャプチャー特性と組み合わせ、そうすることにより、写真ドキュメンテーションのプロセスを単純化する。メディスコープは、Canon Powershot G10(14.7 Mega Pixel)を利用する。このカメラは、直ちにオンスクリーンで見ることのできる極めて優れた品質で写真を撮る。全般的なイメージングプロセスは、ソフトウェアにより完全に制御されている。オーバーレイ特性は、ベースラインイメージがライブプレビューイメージの上にオーバーレイされるのを可能にし、したがって、毎回の訪問時にほぼ正確に再配置することを確実にする。各訪問時に、頭皮(頭の頭頂部)の1つのデジタル画像を収集した。各訪問時に、各対象の毛髪が、修正したVisual Analog Scale(VAS)を用いてコスメトロジストにより評価された。コスメトロジストは、毛髪の太さ/量の評価と一致する100mmVASスケール上の位置を、スケール上のラベルされた垂直位に関して選択した。続いて、記録された印および線の左起点の間の距離をミリメートルで測定し、評価されるパラメータの範囲に関する数値スコアの評価を可能にした。
各訪問時に、毛髪は、Free&Clear(商標)シャンプーアンドコンディショナーを用いて、研究所でコスメトロジストによりシャンプー/コンディショナーされた。対象は、掛け布(毛髪の色の濃い対象には白色、および、毛髪の色の薄い対象には黒色)を身に付けた。毛髪は、必要な場合は、コームまたはピックを用いてもつれをほぐした。毛髪を5つの部分に分けた。各部分を、歯が広いコームを用いて5つのストロークに関して根元から末端までとかした。掛け布の上またはシンク中に抜け落ちた毛髪を全て収集して数えた。それから毛髪をフィンガーブローで乾かした。毛髪が渇いた時点で、毛髪を5つの部分に分けた。各部分を、歯が広いコームを用いて5つのストロークに関して根元から末端までとかした。掛け布の上に落ちた毛髪を全て収集して数えた。
各訪問時の、(湿潤および乾燥を合わせた)合計の毛髪数および毛髪の外観の臨床採点に関するスコアを、各対象および処置についてリスト化して、統計的に分析した。2つの因子(固定効果としての時間およびランダム効果としての対象)での分散分析の後にダネット検定を適用して、ベースラインおよび各処置後インターバル(4週、8週、12週、16週、20週、および24週)の間の違いを判定した。分散分析の残余が正規分布しない場合は(1%の閾値でのシャピロ・ウィルク検定)、この分析は順位で(on rank)行なった。
Claims (28)
- 毛髪保持を促進するための製剤であって、
前記製剤は:
毛髪保持促進物質;
ペプチダーゼ、リパーゼまたはそれらの組み合わせから選択される、1つまたは複数の酵素;および
水性担体、を含む、
製剤。 - 請求項1の製剤であって、
前記の毛髪保持促進物質は、紅参の抽出物である、
製剤。 - 請求項1の製剤であって、
前記の毛髪保持促進物質は、ヘスペリジンまたはグルコシルヘスペリジンである、
製剤。 - 請求項1の製剤であって、
前記の毛髪保持促進物質は、ジヒドロ−テストステロン阻害剤である、
製剤。 - 請求項1の製剤であって、
前記の1つまたは複数の酵素は、ペプチダーゼを含む、
製剤。 - 請求項5の製剤であって、
前記ペプチダーゼは、トリプシンまたは卵孵化タンパク質である、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
前記の1つまたは複数の酵素は、コリオリシンである卵孵化タンパク質を含む、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
前記の1つまたは複数の酵素は、ゾナーゼである卵孵化タンパク質を含む、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
レクチンタンパク質またはロイコレクチンタンパク質をさらに含む、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
前記の毛髪保持促進物質でもなく前記の1つまたは複数の酵素でもない抗酸化剤をさらに含む、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
前記の毛髪保持促進物質でもなく前記の1つまたは複数の酵素でもない殺生物剤をさらに含む、
製剤。 - 請求項1から6のいずれか一項の製剤であって、
前記水性担体は、pH4〜8である、
製剤。 - 請求項1の製剤であって、
前記の毛髪保持促進物質でもなく前記の1つまたは複数の酵素でもない抗炎症剤をさらに含む、
製剤。 - 請求項13の製剤であって、
抗炎症剤は、非ステロイド性抗炎症薬である、
製剤。 - 対象の頭皮上の毛髪保持を促進するプロセスであって、
前記プロセスは:
剥脱を促進する酵素;および
前記酵素でない毛髪保持促進物質を、
前記対象の前記頭皮に局所的に投与するステップを含む、
プロセス。 - 請求項15のプロセスであって、
前記の毛髪保持促進物質を投与するステップの前に、前記酵素を投与するステップが生じる、
プロセス。 - 請求項15のプロセスであって、
前記酵素および前記の毛髪保持促進物質は、同時に投与される、
プロセス。 - 請求項15から17のいずれかのプロセスであって、
前記酵素および前記の毛髪保持促進物質は、1週間に少なくとも3回、少なくとも1ヶ月の間、投与される、
プロセス。 - 対象の頭皮上の毛髪保持を促進するためのキットであって、
前記キットは:
ペプチダーゼ、リパーゼ、またはそれらの組み合わせから選択される1つまたは複数の剥脱酵素を含む、第一の製剤;
前記の第一とは別であり、前記の1つまたは複数の酵素ではない毛髪保持促進物質を含む、第二の製剤;および
前記の第一および第二の製剤を、対象の前記頭皮に投与するための説明書、
を含む、パッケージングを含む、
キット。 - 請求項19のキットであって、
前記の第二の製剤は、疎水性相を含む、
キット。 - 請求項19または20のキットであって、
前記の第二の製剤は、水中油または油中水エマルションである、
キット。 - 請求項19または20のキットであって、
前記の第一および第二の製剤の少なくとも1つは、ポンプスプレーを備える容器中にある、
キット。 - 請求項19から20のいずれか一項のキットであって、
前記の第一の製剤は、滅菌容器中にある、
キット。 - 対象の頭皮上の毛髪保持を促進するためのキットであって、
前記キットは:
(a)水性担体中の、ペプチダーゼ、リパーゼ、またはそれらの組み合わせから選択される1つまたは複数の剥脱酵素;および(b)毛髪保持促進物質、を含む製剤;および
対象の前記頭皮に、前記製剤を投与するための説明書、
を含む、パッケージングを含む、
キット。 - 請求項24のキットであって、
前記製剤は、水溶液または懸濁液である、
キット。 - 請求項24のキットであって、
前記製剤は、エマルションである、
キット。 - 請求項24から26のいずれか一項のキットであって、
前記製剤は、ポンプスプレーを備える容器中にある、
キット。 - 請求項24から26のいずれか一項のキットであって、
前記製剤は、滅菌容器中にある、
キット。
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US201361915988P | 2013-12-13 | 2013-12-13 | |
US61/915,988 | 2013-12-13 | ||
PCT/US2014/070126 WO2015089461A1 (en) | 2013-12-13 | 2014-12-12 | Exfoliative hair retention-promoting formulation |
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JP2016539987A5 JP2016539987A5 (ja) | 2017-02-02 |
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US (1) | US9248167B2 (ja) |
EP (1) | EP3091961A4 (ja) |
JP (1) | JP6089152B2 (ja) |
KR (1) | KR20160098294A (ja) |
CN (1) | CN105813627A (ja) |
AU (1) | AU2014361780B2 (ja) |
CA (1) | CA2933367A1 (ja) |
IL (1) | IL246041A (ja) |
MX (1) | MX2016007617A (ja) |
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WO2019027239A3 (ko) * | 2017-08-01 | 2019-03-28 | 주식회사 씨케이바이오텍 | 탈모 방지 또는 발모 촉진용 조성물 |
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Publication number | Priority date | Publication date | Assignee | Title |
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KR20190013575A (ko) * | 2017-08-01 | 2019-02-11 | 주식회사 씨케이바이오텍 | 탈모 방지 또는 발모 촉진용 조성물 |
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CN111093620A (zh) * | 2017-08-01 | 2020-05-01 | Ck生物技术公司 | 用于预防毛发脱落或促进毛发生长的组合物 |
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AU2014361780A1 (en) | 2016-06-02 |
JP6089152B2 (ja) | 2017-03-01 |
MX2016007617A (es) | 2016-10-04 |
AU2014361780A2 (en) | 2016-06-23 |
KR20160098294A (ko) | 2016-08-18 |
PH12016500930A1 (en) | 2016-06-27 |
PH12016500930B1 (en) | 2016-06-27 |
CN105813627A (zh) | 2016-07-27 |
AU2014361780B2 (en) | 2016-11-24 |
IL246041A (en) | 2017-04-30 |
US20150165002A1 (en) | 2015-06-18 |
WO2015089461A1 (en) | 2015-06-18 |
US9248167B2 (en) | 2016-02-02 |
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