JP2010200971A - Method for predicting/estimating abnormal hair loss, precaution/prevention method for abnormal hair loss, and method for evaluating abnormal hair loss preventive agent - Google Patents

Method for predicting/estimating abnormal hair loss, precaution/prevention method for abnormal hair loss, and method for evaluating abnormal hair loss preventive agent Download PDF

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JP2010200971A
JP2010200971A JP2009049759A JP2009049759A JP2010200971A JP 2010200971 A JP2010200971 A JP 2010200971A JP 2009049759 A JP2009049759 A JP 2009049759A JP 2009049759 A JP2009049759 A JP 2009049759A JP 2010200971 A JP2010200971 A JP 2010200971A
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hair
hair loss
erythema
abnormal
scalp
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Yuki Maruhashi
佑基 丸橋
Emi Kamiya
江美 神谷
Masaaki Sakura
正明 佐倉
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Hoyu Co Ltd
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Hoyu Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a means of simply predicting/estimating hair loss where a substantially conical matter adheres to the hair root with good reliability, and to provide a method for predicting/estimating abnormal hair loss utilizing the means, a precaution/prevention method for abnormal hair loss, and a method for evaluating abnormal hair loss preventive agent. <P>SOLUTION: In this method, the degree and area of erythema appearing on the scalp is evaluated in numerical terms to calculate a erythema score, which is used to predict hair loss whether there is a development where a substantially conical matter adheres to the hair root appears, or to estimate whether the appearing hair loss mainly includes abnormal hair loss. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

本発明は、異常脱毛予測/推定方法、異常脱毛予防/防止方法及び異常脱毛防止剤評価方法に関する。更に詳しくは本発明は、毛根に略円錐形状の物質が付着した状態で脱毛が起こるという異常脱毛を頭皮観察に基いて簡易に予測あるいは推定する異常脱毛予測/推定方法と、この方法に基き予測あるいは推定された特定の異常脱毛に対して有効な脱毛防止剤を好適な製剤組成下に適用する異常脱毛予防/防止方法と、上記の異常脱毛予測/推定方法を応用した合理的で簡易な異常脱毛防止剤評価方法に関する。   The present invention relates to an abnormal hair loss prediction / estimation method, an abnormal hair loss prevention / prevention method, and an abnormal hair loss prevention agent evaluation method. More specifically, the present invention relates to an abnormal hair loss prediction / estimation method that easily predicts or estimates abnormal hair loss based on observation of the scalp, in which hair loss occurs when a substance having a substantially conical shape is attached to the hair root, and prediction based on this method. Alternatively, an abnormal hair loss prevention / prevention method in which an anti-hair loss agent effective against the estimated specific abnormal hair loss is applied under a suitable pharmaceutical composition, and a rational and simple abnormality applying the abnormal hair loss prediction / estimation method described above The present invention relates to a method for evaluating a hair loss inhibitor.

なお、本発明において、単に「毛髪」というときは、特段のことわりがない限り、頭髪を意味する。   In the present invention, “hair” simply means hair unless otherwise specified.

人間の毛髪は、それぞれがヘアサイクルに従って、成長期、退行期、休止期を経て、最終的に脱毛する。そして、正常な状態では1日あたり100本程度が自然に脱毛する。このような正常な脱毛に加え、何らかの要因によってヘアサイクルに異常を来たし、それ以上に脱毛が進行する異常脱毛が知られている。   Human hair finally undergoes hair loss through a growth phase, a regression phase, and a resting phase according to the hair cycle. In a normal state, about 100 hairs per day are naturally removed. In addition to such normal hair loss, abnormal hair loss has been known in which abnormalities have occurred in the hair cycle due to some factor, and hair loss proceeds further.

異常脱毛としては、主として男性ホルモンであるテストステロンが誘発する男性型脱毛、皮脂分泌の異常に基き生じる脂漏性脱毛、強いストレスにより自立神経のバランスが崩れたときに起こる神経性脱毛、乾燥したフケによる毛穴の閉塞に基く粃糠性脱毛等が代表的に例示される。   Abnormal hair loss includes androgenetic hair loss mainly caused by the male hormone testosterone, seborrheic hair loss caused by abnormal sebum secretion, nervous hair loss that occurs when the balance of the independent nerves is disrupted by strong stress, and dry dandruff A typical example is dwarf hair removal based on the blockage of pores due to the above.

以上の多様な異常脱毛に対して、脱毛の抑制あるいは毛成長の促進等を目的とする養毛・育毛剤が数多く提案され、かつ市販されている。これらの養毛・育毛剤は、主に頭皮を清潔に保ったり、頭皮の血行を促進して毛乳頭を刺激することにより、毛髪の成長を促進すること等を狙いとするものである。   In response to the various abnormal hair loss described above, many hair nourishing / hair-growth agents aimed at suppressing hair loss or promoting hair growth have been proposed and marketed. These hair nourishing / hair-growth agents are aimed mainly at promoting hair growth by keeping the scalp clean or stimulating blood circulation of the scalp by stimulating blood circulation of the scalp.

以下に、代表的な従来技術に係る幾つかの特許文献を挙げる。これらの特許文献に開示された発明はいずれも、一般的な毛髪成長の促進あるいは脱毛抑制等を目的とする評価方法に関するものである。又、いずれの特許文献も育毛剤等の評価方法(スクリーニング方法)の発明を含むが、スクリーニングに供する試料としては、評価対象成分を含有するアルコール系の組成物を用いている。   Listed below are some patent documents related to typical prior art. The inventions disclosed in these patent documents all relate to an evaluation method for the purpose of promoting general hair growth or suppressing hair loss. Moreover, although all patent documents include invention of the evaluation method (screening method), such as a hair restorer, the alcoholic composition containing the evaluation object component is used as a sample used for screening.

特許第3227400号公報。この特許文献1は、マウスに育毛剤を塗布することで育毛剤を評価する方法の発明を開示する。その評価対象となる効果は毛成長期の早期誘導及び生長期間の延長であり、効果の判定指標としてメラニン顆粒による皮膚色の変化を採用している。Japanese Patent No. 3227400. This Patent Document 1 discloses an invention of a method for evaluating a hair growth agent by applying the hair growth agent to a mouse. The effects to be evaluated are the early induction of hair growth period and the extension of the growth period, and the change in skin color due to melanin granules is adopted as an index for determining the effect.

特開2005−308730号公報。この特許文献2では、頭皮におけるマトリックスメタロプロテアーゼ11の発現状態を指標として、頭皮の抜け易さあるいは細毛化を判断する頭皮検査方法と、その方法による育毛剤のスクリーニング方法の発明を開示している。JP 2005-308730 A. This Patent Document 2 discloses an invention of a scalp inspection method for determining the ease of scalp removal or thinning using the expression state of matrix metalloproteinase 11 in the scalp as an index, and a method for screening a hair-growth agent by that method. .

特開2005−304491号公報。この特許文献3では、成長期毛包において発現の亢進する遺伝子群の発現状態を指標として、それらの遺伝子の発現量により脱毛や細毛化を予知する方法と、その方法による育毛剤等のスクリーニング方法の発明を開示している。JP-A-2005-304491. In this patent document 3, a method for predicting hair loss and hair thinning based on the expression level of a gene group whose expression is enhanced in a growth stage hair follicle as an index, and a screening method for a hair growth agent or the like by the method The invention is disclosed.

養毛・育毛剤は、上記の特許文献1〜特許文献3にも見られるように、有効成分の製剤上の理由や、頭皮に適用した際の爽快感、アルコールの殺菌効果等を期待して、アルコール系の製剤とすることが一般的である。   As seen in the above-mentioned Patent Literature 1 to Patent Literature 3, the hair nourishing / hair restoring agent is expected for reasons of formulation of the active ingredient, a refreshing feeling when applied to the scalp, an alcohol bactericidal effect, etc. Generally, an alcohol-based preparation is used.

ところが、頭皮の乾燥が原因となって生じるとされる「毛根に略円錐形状の物質が付着した毛髪の脱毛」(その重度あるいは典型的なものが「粃糠性脱毛」である)に対しては、養毛・育毛剤に含有される有効成分の効果以前の問題として、アルコール系の製剤を適用すること自体が頭皮の乾燥を促進し、脱毛を悪化させる恐れがある。ここに、「毛根に付着した略円錐形状の物質」とは、皮膚組織に由来する未知の物質であって、未角化物であるという推定も可能であるが、そうではない可能性もある。   However, against "hair loss with hair of a substantially conical shape attached to the hair root" (severe or typical is "hair loss"), which is said to be caused by dryness of the scalp. As a problem before the effect of the active ingredient contained in the hair nourishing / hair-growing agent, the application of the alcohol-based preparation itself promotes the drying of the scalp and may worsen the hair loss. Here, the “substantially conical substance attached to the hair root” is an unknown substance derived from the skin tissue, and it can be estimated that it is an unkeratinized substance, but it may not be.

なお、本明細書において、以下、「毛根に略円錐形状の物質が付着した毛髪」を「円錐形状物質付着毛髪」と呼び、「毛根に略円錐形状の物質が付着した毛髪の脱毛」を「円錐形状物質付着脱毛」と呼ぶことがある。   In the present specification, hereinafter, “hair having a substantially cone-shaped substance attached to the hair root” is referred to as “cone-shaped substance-attached hair”, and “hair removal of a hair having a substantially cone-shaped substance attached to the hair root” is referred to as “ It may be called “cone-shaped substance-attached hair loss”.

以上の点を考慮すれば、異常脱毛の予防又は防止措置を講ずるに当たり、その異常脱毛が主としてどのような種類の脱毛であるのかを予め知る必要がある。養毛・育毛や脱毛防止のための有効成分をスクリーニングするに当たっても、アルコール系製剤適用下の評価では、粃糠性脱毛を含めた円錐形状物質付着脱毛に対する有効成分を合理的に評価できない恐れがある。   In consideration of the above points, it is necessary to know in advance what kind of hair loss the abnormal hair loss is when taking preventive or preventive measures for abnormal hair loss. Even when screening for active ingredients for hair restoration, hair growth prevention and hair loss prevention, there is a possibility that the evaluation of the active ingredients against conical-shaped substance-attached hair loss, including dwarf hair removal, may not be rationally evaluated in the evaluation under the application of alcohol-based preparations. is there.

上記の理由から異常脱毛の主原因を調査しようとする際、通常の着想としては、脱毛の原因によって毛髪の毛根の形状が異なる、という技術常識の利用が考えられる。例えば、図1に示すような正常に脱毛した毛髪の毛根と異なり、図2のように、毛根部に略細円錐形状の、未角化物とも推定される皮膚組織由来の未知物質が付着した特異的な形状の異常脱毛が優勢に起こる場合は、粃糠性脱毛又はその軽度あるいは予備的な段階にあると推定されることが知られている。従って、脱毛した毛髪を全て収集し、これらの毛髪の毛根の形状を観察して、全体として如何なる脱毛原因が優勢であるかを判定する方法が考えられる。しかし、このような方法は極めて大きな労力を必要とする困難な作業である。   When trying to investigate the main cause of abnormal hair loss for the above reasons, the usual idea is to use the common technical knowledge that the shape of the hair root differs depending on the cause of hair loss. For example, unlike the hair root of hair that has been normally depilated as shown in FIG. 1, as shown in FIG. 2, an unusual substance derived from skin tissue, which is presumed to be an unkeratinized substance, has a substantially fine cone shape at the hair root. It is known that if abnormal hair loss of a typical shape occurs predominantly, it is presumed that it is dwarf hair loss or its mild or preliminary stage. Therefore, it is conceivable to collect all the hair that has been removed and to observe the shape of the roots of these hairs to determine what cause of hair loss is dominant as a whole. However, such a method is a difficult task requiring a great deal of labor.

そこで本発明は、円錐形状物質付着脱毛を良好な信頼性のもとに簡易に予測/推定できる手段を提示すると共に、この手段を利用して合理的に構成された異常脱毛予測/推定方法と、異常脱毛予防/防止方法と、異常脱毛防止剤の評価方法とを提供することを、解決すべき技術的課題とする。   Therefore, the present invention presents a means for easily predicting / estimating conical-shaped substance-attached hair loss with good reliability, and an abnormal hair loss prediction / estimation method rationally constructed using this means, It is a technical problem to be solved to provide a method for preventing / preventing abnormal hair loss and a method for evaluating an abnormal hair loss inhibitor.

本願発明者は、頭皮の皮膚状態と脱毛の関係に注目して調査を行う過程で、頭皮の皮膚トラブルを有する人が徐々に増加しており、同時に脱毛の悩みを抱える人が多くなってきていることを知った。そして更に研究を進めた結果、頭皮における紅斑の発現度と、全脱毛中における円錐形状物質付着毛髪の割合との間に相関があることを突き止め、本発明を完成した。   The inventor of the present application has gradually increased the number of people who have skin troubles of the scalp in the process of investigating the relationship between the skin condition of the scalp and hair loss, and at the same time, the number of people who suffer from hair loss has increased. I knew that As a result of further research, the present inventors completed the present invention by ascertaining that there is a correlation between the degree of erythema on the scalp and the proportion of conical substance-attached hair during total hair loss.

(第1発明)
上記課題を解決するための本願第1発明の構成は、頭皮上に発現した紅斑の度合いを数値化して紅斑スコアを算出し、この紅斑スコアに基いて毛根に略円錐形状の物質が付着した毛髪の脱毛の発現の有無を予測し、あるいは既に発現している脱毛が毛根に略円錐形状の物質が付着した毛髪を主体とするものであるか否かを推定する、異常脱毛予測/推定方法である。
(First invention)
The configuration of the first invention of the present application for solving the above problem is to calculate the erythema score by quantifying the degree of erythema expressed on the scalp, and hair having a substantially conical substance attached to the hair root based on this erythema score An abnormal hair loss prediction / estimation method that predicts the presence or absence of hair loss of hair, or estimates whether the hair loss that has already occurred is mainly hair with a substantially conical substance attached to the hair root is there.

ここで頭皮の「紅斑」とは、頭皮の皮膚の色が正常な部分と比較して常時赤みを帯びた状態となっているか、又は軽く押さえつける程度の物理的な刺激によって容易に赤みを生じる状態になっていることを指す。第1発明においては、頭皮における紅斑の発現度と全脱毛中における円錐形状物質付着毛髪の割合との間に正の相関があるという知見を利用している。実施例において後述するように、この相関は信頼性があるので、円錐形状物質付着脱毛を良好な信頼性のもとに簡易に予測できる手段となる。従って、頭皮における紅斑の発現度(紅斑の度合い)を数値化して定量的・客観的な紅斑スコアを算出すれば、この紅斑スコアに基いて円錐形状物質付着脱毛の発現の有無を予測したり、既に発現している脱毛が円錐形状物質付着毛髪を主体とするか否かの推定を行ったりすることが簡易に可能である。   Here, the “erythema” of the scalp is a state in which the skin color of the scalp is always reddish compared to the normal part, or a state in which redness is easily caused by a physical stimulus enough to lightly press. It means that it is. In the first invention, the knowledge that there is a positive correlation between the degree of erythema on the scalp and the proportion of conical substance-attached hair during total hair removal is used. As will be described later in Examples, since this correlation is reliable, it provides a means for easily predicting conical substance-attached hair loss with good reliability. Therefore, if the degree of erythema on the scalp (the degree of erythema) is quantified and a quantitative and objective erythema score is calculated, the presence or absence of cone-shaped substance-attached hair loss can be predicted based on this erythema score, It is possible to easily estimate whether the hair loss that has already occurred is mainly conical-shaped substance-attached hair.

なお、前記の特許文献1〜特許文献3を含む従来の公知技術において、アルコール系製剤を適用することに対する配慮が認められる記載はなく、紅斑の発現度と円錐形状物質付着脱毛との相関を明示又は示唆する記載もない。   In addition, in the conventional well-known techniques including the above-mentioned Patent Document 1 to Patent Document 3, there is no description that considers application of an alcohol-based preparation, and the correlation between the degree of erythema expression and conical substance-attached hair loss is clearly indicated. There is also no suggestion.

(第2発明)
上記課題を解決するための本願第2発明の構成は、前記第1発明に係る紅斑スコアの算出方法が、頭皮を複数のエリアに分け、その各エリアごとに紅斑の度合いを2段階又は3段階以上にランク付けして点数評価し、これらの点数の合計点を紅斑スコアとするものである、異常脱毛予測/推定方法である。
(Second invention)
The configuration of the second invention of the present application for solving the above problem is that the method for calculating the erythema score according to the first invention divides the scalp into a plurality of areas, and the degree of erythema is divided into two or three stages for each area. It is an abnormal hair loss prediction / estimation method that ranks as described above, evaluates the score, and uses the total score of these scores as the erythema score.

紅斑スコアの算出方法は、頭皮上に発現した紅斑の度合いを数値化したものである限りにおいて限定されないが、第2発明に規定した算出方法を好ましく例示することができる。   The calculation method of the erythema score is not limited as long as it is a numerical value of the degree of erythema expressed on the scalp, but the calculation method defined in the second invention can be preferably exemplified.

第2発明において、「頭皮を複数のエリアに分ける」とは、略半球状に観念される頭皮の全エリアを、例えば前頭部、中頭部、後頭部のように前後方向に三つのエリアに分け、かつ、右頭部、中頭部、左頭部のように左右方向に三つのエリアに分けることをいう。その場合、頭皮を合計九つのエリアに分けることになる。又、「紅斑の度合いを2段階又は3段階以上にランク付けして点数評価する」とは、例えば「紅斑を認めない」と「紅斑を認める」の2段階にランク分けして前者を1点、後者を2点とするような点数評価を意味する。3段階以上にランク付けする場合には、例えば「紅斑を認めない」場合を1点とすると共に、「紅斑を認める」場合を紅斑の色の強さに応じて薄い紅斑から濃色の紅斑までを2点〜4点の3ランクに分けたり、2点〜5点の4ランクに分けたりすることができる。その他の方法としては、エリアの全面積を10とした場合に、紅斑が占める面積の割合に応じて0〜10の11段階で評価を行う、全エリアの評価点を合計することもできる。以上に例示した紅斑スコアの算出方法においては、高スコアであるほど円錐形状物質付着脱毛が強く推定される。   In the second aspect of the invention, “dividing the scalp into a plurality of areas” means that the entire area of the scalp, which is roughly hemispherical, is divided into three areas in the front-rear direction such as the frontal, middle, and occipital areas. It is divided into three areas in the left-right direction such as right head, middle head and left head. In that case, the scalp is divided into a total of nine areas. “Evaluate the score by ranking the degree of erythema to 2 or 3 levels”, for example, rank it into 2 levels, “No erythema” and “Accept erythema”. , Meaning the score evaluation so that the latter is 2 points. When ranking in three or more levels, for example, “no erythema” is scored as one point, and “erythema is recognized” is classified from light erythema to dark erythema according to the strength of erythema color. Can be divided into 3 ranks of 2 to 4 points, or 4 ranks of 2 to 5 points. As another method, when the total area of the area is set to 10, the evaluation points of all the areas that are evaluated in 11 stages of 0 to 10 according to the ratio of the area occupied by erythema can be totaled. In the method for calculating the erythema score exemplified above, the higher the score, the stronger the estimation of conical substance-attached hair loss.

(第3発明)
上記課題を解決するための本願第3発明の構成は、第1発明又は第2発明に記載された紅斑スコアに基き、毛根に略円錐形状の物質が付着した毛髪の脱毛の発現が予測され、あるいは既に発現している脱毛が毛根に略円錐形状の物質が付着した毛髪を主体とするものであると推定された場合は、毛根に略円錐形状の物質が付着した毛髪の脱毛に対する抑制効果が認められる有効成分を含有する低アルコール系の製剤を頭皮に適用する、異常脱毛予防/防止方法である。
(Third invention)
The configuration of the third invention of the present application for solving the above problems is based on the erythema score described in the first invention or the second invention, and it is predicted that hair loss occurs in a hair with a substantially conical substance attached to the hair root, Alternatively, when it is estimated that the hair loss that has already occurred is mainly composed of hair having a substantially conical substance attached to the hair root, the hair removal having a substantially conical substance attached to the hair root has an inhibitory effect on hair loss. This is a method for preventing / preventing abnormal hair loss, in which a low-alcohol preparation containing an recognized active ingredient is applied to the scalp.

第3発明においては、信頼性のある紅斑スコアに基いて円錐形状物質付着脱毛の発現の有無を予測し、あるいは既に発現している脱毛が円錐形状物質付着毛髪を主体とするか否かを推定し、その結果に応じて、アルコール系製剤を適用すること自体が脱毛を悪化させる恐れがある場合には低アルコール系の製剤を適用するので、有効成分による異常脱毛の的確な予防/防止を図ることができる。   In the third invention, the presence or absence of the occurrence of conical substance-attached hair loss is predicted based on a reliable erythema score, or whether or not the already-developed hair loss is mainly composed of cone-shaped substance attached hair is estimated. However, depending on the result, when the alcohol-based preparation itself may deteriorate hair loss, a low-alcohol-based preparation is applied. be able to.

(第4発明)
上記課題を解決するための本願第4発明の構成は、毛根に略円錐形状の物質が付着した毛髪の脱毛に対する抑制効果が認められる有効成分をスクリーニングするための評価方法であって、評価の対象物質を含有する低アルコール系の製剤を調製して紅斑が認められる人の頭皮に適用し、第1発明又は第2発明に記載された紅斑スコアの改善により前記対象物質を評価する、異常脱毛防止剤評価方法である。
(Fourth invention)
The configuration of the fourth invention of the present application for solving the above-mentioned problem is an evaluation method for screening an active ingredient having an inhibitory effect on hair loss of hair having a substantially conical substance attached to the hair root, and is subject to evaluation Preparation of a low-alcohol-based preparation containing a substance, applying it to the scalp of a person with erythema, and evaluating the target substance by improving the erythema score described in the first or second invention, preventing abnormal hair loss It is an agent evaluation method.

第4発明においては、アルコール系製剤の適用下では合理的に評価できない円錐形状物質付着脱毛抑制成分のスクリーニングに当たり、評価の対象物質を含有する低アルコール系の製剤を調製して紅斑が認められる人の頭皮に適用し、かつ信頼性のある紅斑スコアに基いて評価するので、合理的かつ信頼性のある簡易な評価が可能である。   In the fourth aspect of the invention, in screening for a conical-shaped substance adhesion hair loss inhibitor that cannot be reasonably evaluated under the application of an alcohol-based preparation, a person who has erythema observed by preparing a low-alcohol-type preparation containing the substance to be evaluated Since it is applied to the scalp and evaluated based on a reliable erythema score, a reasonable and reliable simple evaluation is possible.

本発明によれば、円錐形状物質付着脱毛を良好な信頼性のもとに簡易に予測/推定できる手段が提示されると共に、この手段を利用して合理的に構成された異常脱毛予測/推定方法、異常脱毛予防/防止方法及び異常脱毛防止剤評価方法が提供される。   According to the present invention, a means for easily predicting / estimating conical-shaped substance-attached hair loss is provided with good reliability, and abnormal hair loss prediction / estimation rationally configured using this means is provided. A method, a method for preventing / preventing abnormal hair loss, and a method for evaluating an abnormal hair loss inhibitor are provided.

正常に脱毛した毛髪の毛根を示す拡大写真である。It is an enlarged photograph which shows the hair root of the hair which carried out normal hair removal. 毛根部に略細円錐形状の物質が付着した異常脱毛を示す拡大写真である。It is an enlarged photograph which shows the abnormal hair loss which the substance of the substantially thin cone shape adhered to the hair root part. 紅斑スコアと円錐形状物質付着毛髪の割合との間の正の相関を示す図である。It is a figure which shows the positive correlation between an erythema score and the ratio of cone-shaped substance adhesion hair.

次に、本発明を実施するための形態を、その最良の形態を含めて説明する。   Next, modes for carrying out the present invention will be described including the best mode.

〔紅斑スコア〕
本発明において紅斑スコアとは、頭皮上に発現した紅斑の度合いを定量的・客観的な評価のために数値化したものである。紅斑スコアは、全脱毛中における円錐形状物質付着毛髪の割合との間に信頼できる正の相関があることが判明している。紅斑スコアの算出方法は、頭皮上に発現した紅斑の度合いを数値化したものである限りにおいて限定されないが、例えば第2発明の算出方法が好ましく例示される。
[Erythema score]
In the present invention, the erythema score is a value obtained by quantifying the degree of erythema expressed on the scalp for quantitative and objective evaluation. It has been found that there is a reliable positive correlation between the erythema score and the proportion of conical shaped substance-attached hair during total hair loss. The calculation method of the erythema score is not limited as long as the degree of erythema expressed on the scalp is digitized, but for example, the calculation method of the second invention is preferably exemplified.

即ち、頭皮を複数のエリアに分け、その各エリアごとに紅斑の度合いを2段階又は3段階以上にランク付けして点数評価し、これらの点数の合計点を紅斑スコアとすることができる。即ち、紅斑スコアは頭皮全体としての判断のために用いられるスコアである。スコアリングに当たっては、頭皮の紅斑の度合いが高いほど高スコアとなる方式でも、頭皮の紅斑の度合いが高いほど低スコアとなる方式でも良い。   That is, it is possible to divide the scalp into a plurality of areas, rank the degree of erythema into two or three or more levels for each area, evaluate the score, and make the total score of these scores the erythema score. That is, the erythema score is a score used for judgment as the whole scalp. In scoring, a higher score may be used as the degree of scalp erythema increases, or a lower score may be used as the degree of scalp erythema increases.

頭皮のエリア分けにおける線引きの方法やエリアの区分数は限定されないが、エリアの区分数が、例えば2区分や3区分にとどまるような場合でも、次に述べる紅斑の度合を例えば50段階にするというように細分化することで信頼性を確保することは可能である。   The method of drawing the scalp area and the number of area divisions are not limited, but even if the number of area divisions is, for example, 2 or 3 divisions, the degree of erythema described below is set to 50 levels, for example. Thus, it is possible to ensure reliability by subdividing.

各エリアごとの紅斑の度合いは、少なくとも2段階に、即ち「紅斑を認めない」と「紅斑を認める」にランク分けして点数評価するが、好ましくは3段階以上にランク付けして点数評価する。3段階以上にランク付けする場合、紅斑の色の強さも評価の対象としてもよい。紅斑の有無やエリア内に占める紅斑面積、その色の強さの評価は、肉眼的視覚による官能評価により行っても良いが、適宜な機械的測定手段により行っても良い。   The degree of erythema for each area is scored in at least two stages, ie, “no erythema is recognized” and “accepts erythema”, and is scored preferably, but is ranked in three or more stages and scored. . When ranking in three or more levels, the intensity of erythema color may also be an object of evaluation. The presence / absence of erythema, the area of erythema occupying the area, and the intensity of the color may be evaluated by sensory evaluation by visual observation, but may be performed by an appropriate mechanical measurement means.

上記の評価における紅斑の認定に関しては、「(a)頭皮の皮膚の色が常時赤みを帯びた状態となっている」ことを基準として認定しても良いし、「(b)軽く押さえつける程度の物理的な刺激によって容易に赤みを生じる」ことを基準として認定しても良い。更に、紅斑の認定において上記の(a)と(b)に同等の重み付けをしても良いし、(b)による認定に比較して(a)による認定をより大きく重み付けするようなランク付けを導入することもできる。   Regarding the recognition of erythema in the above evaluation, it may be recognized based on “(a) the skin color of the scalp is always reddish” or “(b) It may be recognized on the basis that “redness is easily caused by physical stimulation”. Furthermore, in the recognition of erythema, the same weighting may be applied to the above (a) and (b), or the ranking that weights the recognition by (a) more than the recognition by (b). It can also be introduced.

〔異常脱毛予測/推定方法〕
本発明に係る異常脱毛予測/推定方法は、上記した紅斑スコアに基いて円錐形状物質付着脱毛の発現の有無を予測し、あるいは既に発現している脱毛が円錐形状物質付着毛髪を主体とするものであるか否かを推定する方法である。
[Abnormal hair loss prediction / estimation method]
The abnormal hair loss prediction / estimation method according to the present invention predicts the presence or absence of cone-shaped substance-attached hair loss based on the above-mentioned erythema score, or the hair loss that has already occurred is mainly composed of cone-shaped substance-attached hair This is a method for estimating whether or not.

この異常脱毛予測/推定方法において、紅斑スコアがどの程度であれば円錐形状物質付着脱毛を予測あるいは推定するかという紅斑スコアの境界値は、紅斑スコアの具体的な算出方法に応じて異なるので、一律に規定することができない。   In this abnormal hair loss prediction / estimation method, the boundary value of the erythema score indicating how much the erythema score is to predict or estimate cone-shaped substance-attached hair loss depends on the specific calculation method of the erythema score, It cannot be defined uniformly.

〔異常脱毛予防/防止方法〕
本発明に係る異常脱毛予防/防止方法は、上記した紅斑スコアに基き、以下(1)を行う方法である。更に、以下(2)の措置を行うことも可能である。
(1)紅斑スコアに基いて円錐形状物質付着脱毛の発現が予測され、あるいは既に発現している脱毛が円錐形状物質付着毛髪を主体とするものであると推定された場合は、円錐形状物質付着脱毛の抑制効果が認められる有効成分を含有する低アルコール系の製剤を頭皮に適用する。
(2)紅斑スコアに基いて円錐形状物質付着脱毛の発現が予測されず、あるいは既に発現している脱毛が円錐形状物質付着毛髪を主体とするものではないと推定された場合には、適宜な有効成分を含有するアルコール系又は低アルコール系の製剤を頭皮に適用する。
[Method of preventing / preventing abnormal hair loss]
The method for preventing / preventing abnormal hair loss according to the present invention is a method of performing (1) below based on the erythema score described above. Furthermore, the following measure (2) can be performed.
(1) When conical-shaped substance-attached hair loss is predicted based on the erythema score, or when it is estimated that the already-developed hair loss is mainly composed of conical-shaped substance-attached hair A low-alcohol preparation containing an active ingredient that is effective in suppressing hair loss is applied to the scalp.
(2) When the occurrence of conical-shaped substance-attached hair loss is not predicted based on the erythema score, or when it is estimated that the already-developed hair loss is not mainly composed of conical-shaped substance-attached hair, An alcoholic or low alcoholic formulation containing the active ingredient is applied to the scalp.

ここにおいて、「円錐形状物質付着脱毛の抑制効果が認められる有効成分」の種類は限定されない。一般的な養毛・育毛剤が数多く市販されており、その中には円錐形状物質付着脱毛に対して有効な成分が含まれている可能性がある。前記した男性型脱毛、脂漏性脱毛、神経性脱毛、粃糠性脱毛等の各種の異常脱毛に対して有効な成分は、必ずしも同じであるとは限らない。円錐形状物質付着脱毛に対する有効成分として、例えば植物抽出液や酵母抽出液等を例示することができる。   Here, the kind of "active ingredient with which the inhibitory effect of conical-shaped substance adhesion hair loss" is recognized is not limited. Many general hair nourishing and hair-growing agents are commercially available, and some of them may contain an effective ingredient for conical substance-attached hair removal. Ingredients effective for various types of abnormal hair loss such as male pattern hair loss, seborrheic hair loss, neurological hair loss and sputum hair loss are not necessarily the same. Examples of active ingredients for conical substance-attached hair removal include plant extracts and yeast extracts.

アルコール系の製剤とは、炭素数1〜3の1価低級アルコールを製剤中10質量%以上含有するものを言う。一方、低アルコール系の製剤とは、上記「アルコール系の製剤」の要件を満たさないもの、つまり、炭素数1〜3の1価低級アルコールを含有しないノンアルコールのものであるか、あるいは炭素数1〜3の1価低級アルコールを含有しても、その含有量が10質量%未満であるものを言う。   The alcohol-based preparation refers to a preparation containing 10% by mass or more of a monovalent lower alcohol having 1 to 3 carbon atoms in the preparation. On the other hand, a low-alcohol formulation is one that does not satisfy the requirements of the above-mentioned “alcohol formulation”, that is, a non-alcohol that does not contain a monovalent lower alcohol having 1 to 3 carbon atoms, or a carbon number. Even if it contains 1-3 monohydric lower alcohols, the content is less than 10% by mass.

〔異常脱毛防止剤評価方法〕
本発明に係る異常脱毛防止剤評価方法は、円錐形状物質付着脱毛の抑制効果が認められる有効成分をスクリーニングするための評価方法であって、評価の対象物質を含有する低アルコール系の製剤を調製して紅斑が認められる人の頭皮に適用し、その適用に伴って前記の紅斑スコアが改善するか否かにより対象物質を評価する方法である。
[Abnormal hair loss prevention agent evaluation method]
The method for evaluating an abnormal hair loss inhibitor according to the present invention is an evaluation method for screening an active ingredient in which a conical-shaped substance-adhesion inhibitory effect is observed, and prepares a low-alcohol preparation containing the substance to be evaluated. Then, the method is applied to the scalp of a person who has erythema, and the target substance is evaluated based on whether or not the erythema score improves with the application.

以下に本発明の実施例を比較例と共に説明する。本発明の技術的範囲は以下の実施例及び比較例によって限定されない。   Examples of the present invention will be described below together with comparative examples. The technical scope of the present invention is not limited by the following examples and comparative examples.

(試験A)
まず適切な被験者を選抜するため、20歳〜39歳の健康な男性82名を被験候補者として、これらの者の頭皮を観察した。頭皮観察は、被験候補者を25℃、50%RHの恒温恒湿条件の部屋で30分間待機させた後に観察を実施した。全頭を前後2エリア、左右4エリアの全8エリアに分け、エリア内の面積を10とした場合に紅斑が占める面積の割合を、「紅斑の占める面積がゼロである」場合の「0」から「紅斑が全面積を占める」場合の「10」までの0〜10の11段階の評価として目視で判断し、そのエリアのランクとした。全8エリアのランク合計を紅斑スコアとしたため、被験候補者の紅斑スコアは0〜80の81段階での評価となった。
(Test A)
First, in order to select appropriate subjects, 82 healthy men aged 20 to 39 years were used as test candidates, and their scalp was observed. The scalp was observed after waiting 30 minutes in a room with a constant temperature and humidity condition of 25 ° C. and 50% RH. Divide the whole head into 2 areas in the front and back and 8 areas in the left and right, and the area in the area is 10, the ratio of the area occupied by erythema is “0” when “the area occupied by erythema is zero” To “10” when “erythema occupies the entire area” was visually evaluated as 11 grades from 0 to 10, and the area was ranked. Since the rank total of all 8 areas was used as the erythema score, the test candidate's erythema score was evaluated in 81 levels from 0 to 80.

次いで、紅斑スコアの結果を表1のとおり10スコアごとに区分し、グループI〜グループIXの9グループに分けた。次に、表2中の「被験者」欄及び「紅斑スコアのグループ」欄に示すように、各グループから、年齢分布が偏らないように、被験者A〜Rの18名を選抜した。なお、グループV、VIIには適切な該当者がいなかったため、これらのグループからは被験者を選抜できなかった。   Next, the results of the erythema score were divided into 10 groups as shown in Table 1, and divided into 9 groups, Group I to Group IX. Next, as shown in the “subject” column and “erythema score group” column of Table 2, 18 subjects A to R were selected from each group so that the age distribution was not biased. In addition, since there were no appropriate persons in groups V and VII, subjects could not be selected from these groups.

次に、選抜された上記被験者A〜Rの脱毛を収集した。各被験者が1日1回洗髪する際、排水口にガーゼを設け、洗髪時に脱毛する毛髪を全て採取し、この作業を3日間繰り返し、一人当たり合計数百本の脱毛毛髪を収集することが出来た。この全脱毛毛髪についてマイクロスコープにより毛根を観察し、正常な脱毛毛髪、毛根に略円錐形状の物質が付着した毛髪の脱毛(円錐形状物質付着脱毛)、円錐形状物質付着脱毛以外の異常脱毛毛髪に分類した。 Next, the hair loss of the selected subjects A to R was collected. When each subject performs hair washing once a day, a gauze is provided at the drain, and all the hair to be removed at the time of washing is collected, and this operation is repeated for 3 days, and a total of several hundred hair removals per person can be collected. It was. This hair removal hair is observed with a microscope and the hair root is observed. For normal hair removal, hair removal with hair having a substantially cone-shaped substance attached to the hair root (cone-shaped substance attachment hair removal), abnormal hair removal other than cone-shaped substance attachment hair removal Classified.

正常な脱毛毛髪の判定は、図1のように毛根が略半球状か否かを基準とした。円錐形状物質付着毛髪は、図2のような形状であって、かつ毛根端部に付着している略細円錐状物質の長さが20μm以上であることを基準とした。前記2種以外と分類された毛髪は、上記以外の異常脱毛毛髪として取り扱ったが、全被験者に関してこのタイプの毛髪は全脱毛毛髪の1〜2%程度しか確認されなかった。   The determination of normal hair removal was based on whether the root of hair was substantially hemispherical as shown in FIG. The cone-shaped substance-attached hair was shaped as shown in FIG. 2 and the length of the substantially fine cone-shaped substance attached to the end of the hair root was 20 μm or more. Although the hair classified as other than the above two types was treated as abnormal hair loss other than the above, only about 1 to 2% of this type of hair was confirmed for all subjects.

表2において、各被験者ごとに全体の脱毛毛髪の本数を示すと共に、その内訳として、正常な毛根であった脱毛毛髪の本数、円錐形状物質付着毛髪の本数、及びそれ以外の異常脱毛毛髪の本数を示す。又、各被験者の全脱毛毛髪の本数中に占める円錐形状物質付着毛髪の本数の割合をパーセンテージで算出して、小数点以下を四捨五入した整数値で示した。   In Table 2, the total number of hair removal hairs is shown for each subject, and the breakdown includes the number of hair removal hairs that were normal hair roots, the number of hairs attached to a cone-shaped substance, and the number of other abnormal hair removal hairs. Indicates. Further, the ratio of the number of conical-shaped substance-attached hairs in the total number of hair removal hairs of each subject was calculated as a percentage, and the whole number after the decimal point was rounded off.

各被験者の上記パーセンテージを頭皮紅斑スコアと比較した結果、被験者全体について、図3のとおりに、頭皮紅斑スコアと上記パーセンテージ(円錐形状物質付着毛髪の割合)の間には正の相関があった。なお、統計計算はStatViewt5.0を用い、One−Way ANOVAで実施した。その結果、p=0.0459となり、p<0.05であるので統計学的に有意差があると判定した。
(試験B)
前記試験Aにおいて紅斑スコアのグループVI及びIXに属した被験者M,Qに対し、表3に記載の処方の通りに調製された実施例1の頭皮用ローションを1日当たり1回、1ヶ月間適用した後、試験Aと同じ方法で、紅斑スコア及び全脱毛毛髪に占める円錐形状物質付着毛髪の割合を算出した。他方、グループVIの被験者Nに対しては比較例1の頭皮用ローションを上記と同様に適用し、紅斑スコア及び全脱毛毛髪に占める円錐形状物質付着毛髪の割合を算出した。結果を表4の「ローション適用後」の欄に示す。「ローション適用前」の欄は表2の転記である。
As a result of comparing the above-mentioned percentage of each subject with the scalp erythema score, as shown in FIG. 3, there was a positive correlation between the scalp erythema score and the above-mentioned percentage (percentage of conical-shaped substance-attached hair) for all subjects. Statistical calculation was performed using One-Way ANOVA using StatView 5.0. As a result, p = 0.0459, and since p <0.05, it was determined that there was a statistically significant difference.
(Test B)
For the subjects M and Q belonging to groups VI and IX of the erythema score in the test A, the lotion for scalp of Example 1 prepared according to the formulation described in Table 3 is applied once a day for one month. After that, the erythema score and the proportion of conical-shaped substance-attached hair in the total hair loss were calculated in the same manner as in Test A. On the other hand, for the subject N of group VI, the lotion for scalp of Comparative Example 1 was applied in the same manner as described above, and the erythema score and the proportion of conical substance-attached hair in the total hair loss were calculated. The results are shown in the column “After application of lotion” in Table 4. The column “Before application of lotion” is a transcription of Table 2.

表4から分かるように、実施例1の頭皮用ローションを適用した被験者M,Qの紅斑スコア及び全脱毛毛髪における円錐形状物質付着毛髪の割合がそれぞれ低下し、「紅斑スコアのグループ」の項に示すようにグループ分けのカテゴリーも番号の若いグループ(紅斑スコアが低いグループ)へ移行した。一方、被験者Nについては、紅斑スコア及び全脱毛毛髪における円錐形状物質付着毛髪の割合が、それぞれローション適用前と比べて改善が見られなかった。 As can be seen from Table 4, the erythema score of subjects M and Q to which the scalp lotion of Example 1 was applied and the proportion of conical-shaped substance-attached hair in the total hair loss decreased, respectively, in the “Erythema score group” section. As shown, the grouping category also moved to the younger numbered group (the group with the lower erythema score). On the other hand, for subject N, the erythema score and the ratio of the conical-shaped substance-attached hair in the total hair loss were not improved as compared to before application of the lotion.

Claims (4)

頭皮上に発現した紅斑の度合いを数値化して紅斑スコアを算出し、この紅斑スコアに基いて毛根に略円錐形状の物質が付着した毛髪の脱毛の発現の有無を予測し、あるいは既に発現している脱毛が毛根に略円錐形状の物質が付着した毛髪を主体とするものであるか否かを推定することを特徴とする異常脱毛予測/推定方法。 The degree of erythema expressed on the scalp is quantified to calculate the erythema score, and based on this erythema score, the presence or absence of hair loss is predicted or already expressed on the hair root with a substantially conical substance attached to the hair root. An abnormal hair loss prediction / estimation method characterized in that it is estimated whether or not the hair loss is mainly hair having a substantially conical substance attached to the hair root. 前記紅斑スコアの算出方法が、頭皮を複数のエリアに分け、その各エリアごとに紅斑の度合いを2段階又は3段階以上にランク付けして点数評価し、これらの点数の合計点を紅斑スコアとするものであることを特徴とする請求項1に記載の異常脱毛予測/推定方法。 The calculation method of the erythema score divides the scalp into a plurality of areas, ranks the degree of erythema in each of the two or more stages, and evaluates the score. The total score of these scores is the erythema score. The abnormal hair loss prediction / estimation method according to claim 1, wherein: 請求項1又は請求項2に記載された紅斑スコアに基き、毛根に略円錐形状の物質が付着した毛髪の脱毛の発現が予測され、あるいは既に発現している脱毛が毛根に略円錐形状の物質が付着した毛髪を主体とするものであると推定された場合は、毛根に略円錐形状の物質が付着した毛髪の脱毛に対する抑制効果が認められる有効成分を含有する低アルコール系の製剤を頭皮に適用することを特徴とする異常脱毛予防/防止方法。 3. Based on the erythema score according to claim 1 or claim 2, the appearance of hair loss is predicted when hair having a substantially conical shape is attached to the hair root, or the hair loss that has already occurred is a material having a substantially conical shape at the hair root. If the hair is presumed to be mainly composed of hair, a low-alcohol preparation containing an active ingredient that has an inhibitory effect on hair loss with a substantially conical substance attached to the hair root is applied to the scalp. An abnormal hair loss prevention / prevention method characterized by applying. 毛根に略円錐形状の物質が付着した毛髪の脱毛に対する抑制効果が認められる有効成分をスクリーニングするための評価方法であって、評価の対象物質を含有する低アルコール系の製剤を調製して紅斑が認められる人の頭皮に適用し、請求項1又は請求項2に記載された紅斑スコアの改善により前記対象物質を評価することを特徴とする異常脱毛防止剤評価方法。 An evaluation method for screening an active ingredient having an inhibitory effect on hair loss with hair having a substantially conical shape attached to a hair root, and preparing a low-alcohol-based preparation containing the target substance to evaluate erythema An abnormal hair loss prevention agent evaluation method, which is applied to a recognized human scalp and evaluates the target substance by improving the erythema score according to claim 1 or 2.
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