KR102601614B1 - A composition comprising Aster yomena callus culture medium as an effective element for preventing hair loss and promoting hair growth - Google Patents
A composition comprising Aster yomena callus culture medium as an effective element for preventing hair loss and promoting hair growth Download PDFInfo
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- KR102601614B1 KR102601614B1 KR1020210037420A KR20210037420A KR102601614B1 KR 102601614 B1 KR102601614 B1 KR 102601614B1 KR 1020210037420 A KR1020210037420 A KR 1020210037420A KR 20210037420 A KR20210037420 A KR 20210037420A KR 102601614 B1 KR102601614 B1 KR 102601614B1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/42—Amides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/67—Vitamins
- A61K8/673—Vitamin B group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/67—Vitamins
- A61K8/673—Vitamin B group
- A61K8/675—Vitamin B3 or vitamin B3 active, e.g. nicotinamide, nicotinic acid, nicotinyl aldehyde
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q5/00—Preparations for care of the hair
- A61Q5/02—Preparations for cleaning the hair
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q7/00—Preparations for affecting hair growth
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Birds (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Dermatology (AREA)
- Cosmetics (AREA)
Abstract
본 발명은 쑥부쟁이캘러스배양액을 유효성분으로 포함하는, 탈모를 예방하고 발모를 촉진하는 외용제 조성물이다. 또한, 나이아신아마이드, 판테놀, 바이오틴 및 멘톨을 추가로 포함하는 것을 특징으로 하는 탈모를 예방하고 발모를 촉진하는 외용제 조성물이다.The present invention is a composition for external use that prevents hair loss and promotes hair growth, containing callus culture medium as an active ingredient. In addition, it is an external composition that prevents hair loss and promotes hair growth, further comprising niacinamide, panthenol, biotin, and menthol.
Description
본 발명은 탈모를 예방하고 발모를 촉진하는 외용제 조성물에 관한 것이다. 본 발명은 연구과제 결과물로서, 연구과제 정보는 다음과 같다. The present invention relates to a composition for external use that prevents hair loss and promotes hair growth. This invention is the result of a research project, and the research project information is as follows.
과제번호 : P0006185, 부처명 : 산업통상자원부Project number: P0006185, Ministry name: Ministry of Trade, Industry and Energy
과제관리전문기관명 : 제주지역사업평가단 Name of project management specialist organization: Jeju Regional Project Evaluation Team
연구사업명 : 광역협력권산업육성사업(지역주도형 R&D)Research project name: Metropolitan cooperation industry development project (region-led R&D)
연구과제명 : 천연 특화자원을 이용한 프리미엄 뷰티 향장 제품 개발 Research project name: Development of premium beauty cosmetic products using natural specialized resources
과제수행기관명 : 제너럴바이오(주) / 참여기관 : 한국생명공학연구원Name of project carrying out organization: General Bio Co., Ltd. / Participating organization: Korea Research Institute of Bioscience and Biotechnology
연구기간 : 2018.10.01~2021.03.31 Research period: 2018.10.01~2021.03.31
탈모증은 사춘기 이후 성인에서 시작되는 비교적 흔한 질환 중의 하나로서 생활 수준의 향상과 피부 미용에 대한 사회적인 관심이 증대됨에 따라 점차적으로 그 치료와 예방책에 대한 관심도 높아지고 있는 질환이다. Alopecia is a relatively common disease that begins in adults after puberty. As living standards improve and social interest in skin care increases, interest in its treatment and prevention is gradually increasing.
탈모의 원인에는 유전적 요인, 잘못된 식생활, 스트레스, 지루성 비듬, 내분비 이상 등이 알려져 있으며 탈모 증상 완화 등을 목적으로 사용하는 외용제는 기능성 화장품으로서 식약처에서 품목별로 안전성 및 효능을 심사하여 허가하고 있다.The causes of hair loss are known to include genetic factors, poor diet, stress, seborrheic dandruff, and endocrine abnormalities. Topical products used for the purpose of alleviating hair loss symptoms are functional cosmetics and are approved by the Ministry of Food and Drug Safety after reviewing the safety and efficacy of each item. .
남성호르몬과 유전에 의해 발생하는 안드로겐 탈모증은 남자와 여자 모두의 약 50%에서 발생하며, 일반적으로 40~50대에 시작하는 경우가 흔하지만 심한 경우는 사춘기 직후에 시작하여 수십 년간 지속되기도 한다. 남자와 여자 모두 탈모는 주로 두정부에서 시작하여 점차 머리전체로 진행하게 되는데, 남자의 경우에는 양측 측두부의 머리선의 후퇴와 두정부에서 탈모가 우세하게 나타나고, 여자의 경우에는 얼굴 두피 모발의 경계선은 일반적으로 잘 보존되며, 크리스마스 나무형태를 보이는 것이 흔하고 완전한 탈모반이 형성되는 것은 드물다. Androgenic alopecia, which is caused by male hormones and genetics, occurs in approximately 50% of both men and women, and generally begins in the 40s or 50s, but in severe cases, it begins immediately after puberty and can last for decades. For both men and women, hair loss mainly starts in the parietal region and gradually progresses to the entire head. In men, receding hair lines on both sides of the head and hair loss predominates in the parietal region, and in women, the boundary line of hair on the facial scalp is It is generally well preserved, and it is common to have a Christmas tree shape, and it is rare for a complete bald spot to form.
탈모의 원인으로 알려져 있는 남성호르몬을 감소시키는 제품들이 개발되어 탈모치료 효과가 기대되었으나 체내 향상성의 불균형으로 인하여 알레르기, 우울증, 국소염증 등의 부작용이 발생하여 그 적용 위험성이 점점 커지고 있는 실정이다. 또, 약물요법의 경우에는 외관상 발모가 가장 필요한 두피부위에 대한 효과가 기대되는 수준에 이르지 못하고 있다. 따라서, 생체에 안전하고 효과가 뛰어날 뿐만 아니라 안정적이고 제조시 경제성이 있는 발모촉진 및 탈모예방 제품의 개발이 절실하게 요구되고 있다.Products that reduce male hormones, which are known to cause hair loss, have been developed and are expected to be effective in treating hair loss. However, due to imbalance in the enhancement properties in the body, side effects such as allergies, depression, and local inflammation occur, and the risk of their application is increasing. In addition, in the case of drug therapy, the effect on the scalp area where hair growth is most needed does not reach the expected level. Therefore, there is an urgent need for the development of hair growth promotion and hair loss prevention products that are not only safe and effective for the living body, but also stable and economical in manufacturing.
선행기술문헌으로는, 대한민국 등록특허공보 10-1229762에 '육모촉진 및 탈모예방 개선용 외용제조성물'이, 대한민국 등록특허공보 10-1445967에 '겨우살이 추출물 및 편백나무 추출물을 유효성분으로 함유하는 탈모예방 및 발모촉진용 샴푸 조성물'이 기재되어 있다. Prior art documents include Korea Patent Publication No. 10-1229762, ‘Composition for external use for promoting hair growth and hair loss prevention,’ and Korea Patent Publication No. 10-1445967, ‘Hair loss prevention containing mistletoe extract and cypress extract as active ingredients. and 'shampoo composition for hair growth promotion' are described.
해결과제는 탈모를 예방하고 발모를 촉진하는 외용제 조성물을 제공하는 것이다.The problem is to provide a composition for external use that prevents hair loss and promotes hair growth.
해결수단은, 쑥부쟁이 캘러스의 배양액을 유효성분으로 포함하는, 탈모를 예방하고 발모를 촉진하는 외용제 조성물이다. 또한, 나이아신아마이드, 판테놀, 바이오틴 및 멘톨을 추가로 포함하는 것을 특징으로 하는, 탈모를 예방하고 발모를 촉진하는 외용제 조성물이다.The solution is an external composition that prevents hair loss and promotes hair growth, containing the culture fluid of Aster callus as an active ingredient. In addition, it is an external composition that prevents hair loss and promotes hair growth, characterized in that it additionally contains niacinamide, panthenol, biotin, and menthol.
본 발명에 따른 조성물은 인체적용시험을 통해 탈모를 예방하고 발모를 촉진하는 효과를 보유하고 있음이 확인되었다.It was confirmed that the composition according to the present invention has the effect of preventing hair loss and promoting hair growth through human application tests.
도 1 내지 도 7은 인체적용시험 결과를 그래프 또는 사진으로 나타낸 도면이다.Figures 1 to 7 are diagrams showing the results of human application tests in graphs or photographs.
본 명세서 및 청구범위에 사용된 용어나 단어는 통상적이거나 사전적인 의미로 한정하여 해석되어서는 아니되며, 발명자가 발명의 용어와 개념을 가장 최선의 방법으로 설명하기 위하여 본 발명의 기술적 사상에 부합하는 의미와 개념에 입각하여 기재한 것으로 해석하여야 한다.Terms or words used in this specification and claims should not be construed as limited to their ordinary or dictionary meanings, and the inventor should use the terms and concepts of the invention in the best possible way to explain them in accordance with the technical idea of the invention. It must be interpreted as written based on meaning and concept.
따라서, 본 발명은 제시되는 실시예에 한정되지 않으며, 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자에 의하여 본 발명의 기술 사상과 아래에 기재될 특허청구범위에 기재된 기술사상의 균등한 범위 내에서 다양한 수정 및 변경이 가능하다.Accordingly, the present invention is not limited to the presented embodiments, and the equivalent scope of the technical idea of the present invention and the technical idea described in the patent claims below can be recognized by those skilled in the art to which the present invention pertains. Various modifications and changes are possible within.
본 발명은 첨부된 도면을 참조하여 바람직한 실시예를 중심으로 기술되었지만 당업자라면 이러한 기재로부터 기술적 범주를 벗어남이 없이 다양한 변형이 가능하다는 것은 명백하다. 따라서 본 발명의 범주는 이러한 많은 변형예 들을 포함할 수 있다.Although the present invention has been described with a focus on preferred embodiments with reference to the accompanying drawings, it is clear to those skilled in the art that various modifications can be made without departing from the technical scope of this description. Accordingly, the scope of the present invention may include many such modifications.
실시예. 탈모를 예방하고 발모를 촉진하는 외용제 조성물Example. A composition for external use that prevents hair loss and promotes hair growth
본 발명에 따른 탈모 예방 및 발모 촉진용 조성물은 주요 유효성분으로서 쑥부쟁이 캘러스의 배양액을 포함하다. 또하, 나이아신아마이드, 판테놀, 바이오틴 및 멘톨을 추가로 포함한다. 본 발명에 따른 조성물은 토닉, 샴푸 및 폼 제품에 이용될 수 있으며, 그 외 두발 및 두피에 적용되는 제품에 모두 이용될 수 있다.The composition for preventing hair loss and promoting hair growth according to the present invention contains a culture medium of Aster callus as a main active ingredient. Additionally, it additionally contains niacinamide, panthenol, biotin, and menthol. The composition according to the present invention can be used in tonic, shampoo, and foam products, and can be used in all other products applied to the hair and scalp.
또한 본 발명에 따른 탈모 예방 및 발모 촉진용 조성물은 하기의 표 1에 기재된 성분을 모두 포함할 수 있다. Additionally, the composition for preventing hair loss and promoting hair growth according to the present invention may include all of the ingredients listed in Table 1 below.
쑥부쟁이 캘러스의 배양액
(Aster Yomena Callus Conditioned Media): 20.58%,
메틸프로판다이올 (Methylpropanediol) : 3%,
다이프로필렌글라이콜 (Dipropylene Glycol): 1.167%,
글리세레스-25피씨에이아이소스테아레이트
(Glycereth-25 PCA Isostearate): 0.8%,
1,2-헥산다이올 (1,2-Hexanediol): 0.453%,
하이드록시아세토페논 (하이드록시아세토페논): 0.402%,
나이아신아마이드 (Niacinamide): 0.3%,
하이드롤라이즈드인삼사포닌 (Hydrolyzed Ginseng Saponins):
0.25%, 판테놀 (Panthenol): 0.25%,
베타인살리실레이트 (Betaine Salicylate): 0.2%,
트로메타민 (Betaine Salicylate): 0.18%,
부틸렌글라이콜 (Butylene Glycol): 0.15%,
멘톨 (Menthol): 0.1%,
구주소나무잎오일 (Pinus Sylvestris Leaf Oil): 0.1%,
아미노레불리닉애씨드에이치씨엘
(Aminolevulinic Acid HCl): 0.1%,
바이오틴 (Biotin): 0.05%, 프로판다이올 (Propanediol): 0.048%,
카프릴릴글라이콜(Caprylyl Glycol): 0.04%,
윈터체리뿌리추출물
(Withania Somnifera Root Extract) : 0.039%,
시카카이열매추출물 (Acacia Concinna Fruit Extract): 0.039%,
님잎추출물 (Acacia Concinna Fruit Extract): 0.039%,
인디안구스베리열매추출물
(Acacia Concinna Fruit Extract): 0.039%,
하수오뿌리추출물
(Polygonum Multiflorum Root Extract): 0.039%,
약모밀추출물 (Houttuynia Cordata Extract) : 0.039%,
울금뿌리추출물
(Curcuma Longa (Turmeric) Root Extract): 0.039%,
병풀추출물 (Curcuma Longa (Turmeric) Root Extract): 0.039%,
주아나무껍질추출물 (Ziziphus Joazeiro Bark Extract): 0.0065%,
카퍼트라이펩타이드-1 (Copper Tripeptide-1): 0.0005%,
헥사펩타이드-2 (Hexapeptide-2): 0.001%,
에스에이치-올리고펩타이드-1 (sh-Oligopeptide-1): 0.000005%,
에스에이치-폴리펩타이드-1 (sh-Polypeptide-1): 0.000001%Purified water: 47.75%, Ethanol: 23.75%,
Culture medium of Aster callus
(Aster Yomena Callus Conditioned Media): 20.58%,
Methylpropanediol: 3%,
Dipropylene Glycol: 1.167%,
Glycereth-25PCA Isostearate
(Glycereth-25 PCA Isostearate): 0.8%,
1,2-Hexanediol: 0.453%,
Hydroxyacetophenone (Hydroxyacetophenone): 0.402%,
Niacinamide: 0.3%,
Hydrolyzed Ginseng Saponins:
0.25%, Panthenol: 0.25%,
Betaine Salicylate: 0.2%,
Tromethamine (Betaine Salicylate): 0.18%,
Butylene Glycol: 0.15%,
Menthol: 0.1%,
Pinus Sylvestris Leaf Oil: 0.1%,
Aminolevulinic Acid HCL
(Aminolevulinic Acid HCl): 0.1%,
Biotin: 0.05%, Propanediol: 0.048%,
Caprylyl Glycol: 0.04%,
Winter cherry root extract
(Withania Somnifera Root Extract): 0.039%,
Acacia Concinna Fruit Extract: 0.039%,
Acacia Concinna Fruit Extract: 0.039%,
Indian gooseberry fruit extract
(Acacia Concinna Fruit Extract): 0.039%,
Hawthorn root extract
(Polygonum Multiflorum Root Extract): 0.039%,
Houttuynia Cordata Extract: 0.039%,
Turmeric root extract
(Curcuma Longa (Turmeric) Root Extract): 0.039%,
Curcuma Longa (Turmeric) Root Extract: 0.039%,
Ziziphus Joazeiro Bark Extract: 0.0065%,
Copper Tripeptide-1: 0.0005%,
Hexapeptide-2: 0.001%,
SH-Oligopeptide-1 (sh-Oligopeptide-1): 0.000005%,
SH-Polypeptide-1 (sh-Polypeptide-1): 0.000001%
상기 표 1은 두피 토닉의 일 예이고, 이 성분들은 샴푸 및 폼 형태의 제품에도 사용될 수 있는데 이때는 제품 제형에 필요한 성분이 추가되고 각 성분의 용량이 일부 조정될 수 있음은 물론이다. Table 1 above is an example of a scalp tonic, and these ingredients can also be used in products in the form of shampoo and foam. In this case, of course, ingredients necessary for the product formulation can be added and the dosage of each ingredient can be partially adjusted.
시험예. 인체적용시험Test example. Human application test
다음은 본 발명에 따른 실시예를 인체적용시험 전문기관에 의뢰하여 도출한 결과를 요약한 것이다.The following is a summary of the results obtained by requesting an example according to the present invention to a human application testing agency.
1) 시험개요1) Exam outline
"케어셀라 나디모 스칼프 토닉 (시험군)" 의 안전성과 탈모 증상 완화에 대한 유효성을 평가하기 위한 시험으로서, 탈모증상이 있는 자를 대상으로 하는 연구로서, 총 24주간의 기간 동안 탈모 증상 완화 유효성 및 안전성을 이중맹검, 대조시료, 무작위 배정 인체 적용 시험을 통해 평가하였다. This is a test to evaluate the safety and effectiveness of "CareCella Nadimo Scalp Tonic (Test Group)" in alleviating hair loss symptoms. This is a study targeting people with hair loss symptoms, and the efficacy and effectiveness in alleviating hair loss symptoms over a total period of 24 weeks. Safety was evaluated through double-blind, controlled sample, randomized human trials.
2) 시험방법2) Test method
시험군 및 대조군의 시료를 이용하였고, 시험인원은 41명으로서 시험군 시료사용 21명 및 대조군 시료사용 20명으로 하였으며, 매일 아침, 저녁 2회 두피에 적당량 분사하여 마사지 하듯 도포하였다.Samples from the test and control groups were used, and the number of people tested was 41, with 21 people using the test group samples and 20 people using the control group samples. An appropriate amount was sprayed on the scalp twice every morning and evening and applied as if massaging.
3) 시험군 및 대조군3) Test group and control group
에탄올 : 23.75%,
쑥부쟁이 캘러스의 배양액 : 20.58%,
메틸프로판다이올 : 3%,
다이프로필렌글라이콜: 1.167%,
글리세레스-25피씨에이아이소스테아레이트: 0.8%,
1,2-헥산다이올: 0.453%,
하이드록시아세토페논 : 0.402%,
나이아신아마이드: 0.3%,
하이드롤라이즈드인삼사포닌 : 0.25%,
판테놀 : 0.25%,
베타인살리실레이트: 0.2%,
트로메타민 : 0.18%,
부틸렌글라이콜 : 0.15%,
멘톨 : 0.1%,
구주소나무잎오일 : 0.1%,
아미노레불리닉애씨드에이치씨엘 : 0.1%,
바이오틴 : 0.05%,
프로판다이올 : 0.048%,
카프릴릴글라이콜 : 0.04%,
윈터체리뿌리추출물 : 0.039%,
시카카이열매추출물 : 0.039%,
님잎추출물 : 0.039%,
인디안구스베리열매추출물 : 0.039%,
하수오뿌리추출물 : 0.039%,
약모밀추출물 : 0.039%,
울금뿌리추출물 : 0.039%,
병풀추출물 : 0.039%,
주아나무껍질추출물 : 0.0065%,
카퍼트라이펩타이드-1 : 0.0005%,
헥사펩타이드-2 : 0.001%,
에스에이치-올리고펩타이드-1: 0.000005%,
에스에이치-폴리펩타이드-1: 0.000001%
Purified water: 47.75% ,
Ethanol: 23.75%,
Culture medium of Aster callus: 20.58%,
Methylpropanediol: 3%,
Dipropylene glycol: 1.167%,
Glycereth-25PCA isostearate: 0.8%,
1,2-hexanediol: 0.453%,
Hydroxyacetophenone: 0.402%,
Niacinamide: 0.3%,
Hydrolyzed ginseng saponin: 0.25%,
Panthenol: 0.25%,
Betaine salicylate: 0.2%,
Tromethamine: 0.18%,
Butylene glycol: 0.15%,
Menthol: 0.1%,
Kuju pine leaf oil: 0.1%,
Aminolevulinic Acid HCL: 0.1%,
Biotin: 0.05%,
Propanediol: 0.048%,
Caprylyl glycol: 0.04%,
Winter cherry root extract: 0.039%,
Shikakai fruit extract: 0.039%,
Neem leaf extract: 0.039%,
Indian gooseberry fruit extract: 0.039%,
Hawthorn root extract: 0.039%,
Medicinal buckwheat extract: 0.039%,
Turmeric root extract: 0.039%,
Centella asiatica extract: 0.039%,
Jua bark extract: 0.0065%,
Copper tripeptide-1: 0.0005%,
Hexapeptide-2: 0.001%,
SH-Oligopeptide-1: 0.000005%,
SH-polypeptide-1: 0.000001%
에탄올: 23.75%,
메틸프로판다이올: 3%,
다이프로필렌글라이콜 : 1.167%,
글리세레스-25피씨에이아이소스테아레이트: 0.8%,
1,2-헥산다이올: 0.453%,
하이드록시아세토페논 : 0.402%,
나이아신아마이드: 0.3%,
하이드롤라이즈드인삼사포닌 : 0.25%,
판테놀: 0.25%,
베타인살리실레이트 : 0.2%,
트로메타민: 0.18%,
부틸렌글라이콜 : 0.15%,
멘톨 : 0.1%,
구주소나무잎오일: 0.1%,
아미노레불리닉애씨드에이치씨엘 : 0.1%,
바이오틴 : 0.05%,
프로판다이올 : 0.048%,
카프릴릴글라이콜: 0.04%,
윈터체리뿌리추출물 : 0.039%,
시카카이열매추출물 : 0.039%,
님잎추출물: 0.039%,
인디안구스베리열매추출물: 0.039%,
하수오뿌리추출물 : 0.039%,
약모밀추출물 : 0.039%,
울금뿌리추출물 : 0.039%,
병풀추출물 : 0.039%,
주아나무껍질추출물 : 0.0065%,
카퍼트라이펩타이드-1: 0.0005%,
헥사펩타이드-2 : 0.001%,
에스에이치-올리고펩타이드-1 : 0.000005%,
에스에이치-폴리펩타이드-1 : 0.000001%
Purified water: 68.33%,
Ethanol: 23.75%;
Methylpropanediol: 3%,
Dipropylene glycol: 1.167%,
Glycereth-25PCA isostearate: 0.8%,
1,2-hexanediol: 0.453%,
Hydroxyacetophenone: 0.402%,
Niacinamide: 0.3%,
Hydrolyzed ginseng saponin: 0.25%,
Panthenol: 0.25%,
Betaine salicylate: 0.2%,
Tromethamine: 0.18%;
Butylene glycol: 0.15%,
Menthol: 0.1%,
Kuju pine leaf oil: 0.1%,
Aminolevulinic Acid HCL: 0.1%,
Biotin: 0.05%,
Propanediol: 0.048%,
Caprylyl glycol: 0.04%,
Winter cherry root extract: 0.039%,
Shikakai fruit extract: 0.039%,
Neem leaf extract: 0.039%,
Indian gooseberry fruit extract: 0.039%,
Hawthorn root extract: 0.039%,
Medicinal buckwheat extract: 0.039%,
Turmeric root extract: 0.039%,
Centella asiatica extract: 0.039%,
Jua bark extract: 0.0065%,
Copper tripeptide-1: 0.0005%,
Hexapeptide-2: 0.001%,
SH-oligopeptide-1: 0.000005%,
SH-polypeptide-1: 0.000001%
4) 시험 대상자 선정기준4) Criteria for selecting test subjects
- 18~54세의 안드로겐성 탈모증으로 진단된 남녀 시험 대상자- Male and female test subjects diagnosed with androgenetic alopecia aged 18 to 54 years
- Norwood Hamiton 분류에 의해 2 또는 2A이상으로 진단된 남성 대상자, Ludwig 분류에 의해 1이상으로 진단된 여성 대상자 - Male subjects diagnosed as 2 or 2A or higher according to the Norwood Hamiton classification, female subjects diagnosed as 1 or higher according to the Ludwig classification
- 연구기간 동안 특별한 모발용품이나 모발관리 및 조작을 하지 않을 대상자 - Subjects who will not use special hair products or hair care or manipulation during the study period
- 연구기간 동안 첫 방문 시점의 머리모양 및 색을 동일하게 유지할 대상자 - Subjects who will maintain the same hairstyle and color as at the first visit during the study period
- 본 시험의 목적을 이해하고 대상자로서 동의서에 서면 동의한 대상자 - Subjects who understand the purpose of this test and agree in writing to the consent form.
5) 평가방법5) Evaluation method
a. Folliscope Phototrichogram을 이용한 모발 수 분석a. Hair Count Analysis Using Folliscope Phototrichogram
평가하고자 하는 탈모부위의 모발을 자른 후 직경 1mm의 작은 점 문신을 하거나 일정 좌표를 기록하여 매번 점 문신 또는 일정 좌표를 중심으로 포토트리코그램을 시행한다. 전체모발수(Total hair counts; number/cm2 ) 1 cm2 원내에 있는 모발수After cutting the hair in the hair loss area to be evaluated, tattoo a small dot with a diameter of 1 mm or record certain coordinates and perform a phototricogram centered on the dot tattoo or certain coordinates each time. Total hair counts (number/cm 2 ) Number of hairs in 1 cm 2 circle
b. 사진 촬영에 의한 시험대상자 평가 b. Subject evaluation by taking photos
인체 사진 촬영 : 고해상도 디지털 카메라(DSLR)를 이용하여 45도 (앞머리선), 90도 (정수리) 두 부위를 평가 시점마다 동일한 조건, 구도 및 위치에서 동일한 부위를 촬영하고 시험 시료 사용 전과 후를 비교한다.Photographing the human body: Using a high-resolution digital camera (DSLR), take pictures of the same area at 45 degrees (frontal line) and 90 degrees (top of head) under the same conditions, composition, and location at each evaluation time, and compare before and after using the test sample. do.
사진 평가 : 육안 평가는 2명의 연구자가 7단계 척도로 육안 평가를 실시하고, 2명의 육안 평가 결과의 평균을 유효성 평가 변수로 활용한다Photo evaluation: Visual evaluation is conducted by two researchers on a 7-level scale, and the average of the two visual evaluation results is used as the validity evaluation variable.
c. 피부과 전문의에 의한 육안 평가c. Visual evaluation by a dermatologist
d. 시험 대상자에 의한 주관적 평가d. Subjective evaluation by test subject
e. 피부과 전문의에 의한 안전성 평가e. Safety evaluation by dermatologists
6) 시험 결과 요지6) Summary of test results
총 24주 동안 시험군 시료를 사용한 시험군의 시험 부위는 1차 유효성 평가 지표인 모발수(N/㎠)가 시험 8주 후부터 시험 전에 비해 통계적으로 유의한 수준 (p<005)으로 증가하였다. 또한 모발수의 그룹간 비교 대조 결과, 주차별 모발수 변화 양상을 그룹간 비교한 교호작용 분석에서 시험군과 대조군 모발수의 주차별 변화양상이 통계적으로 유의한 수준(p<005)의 차이를 가지는 것을 확인하였고, 모발수 변화량 비교에서도 8주 경과 이후 시험군과 대조군 간의 모발수 변화량이 통계적으로 유의한 수준(p<005)의 차이를 가지는 것을 확인할 수 있었다. 따라서 본 시험에 사용된 시험 시료가 탈모 증상 완화에 도움을 주는 것으로 판단된다.In the test area of the test group where test group samples were used for a total of 24 weeks, the number of hairs (N/cm2), the primary efficacy evaluation indicator, increased to a statistically significant level (p<005) from 8 weeks after the test compared to before the test. In addition, as a result of comparing and contrasting the hair count between groups, the interaction analysis comparing the weekly hair count change pattern between groups showed a statistically significant difference (p<005) in the weekly change pattern between the test group and the control group hair count. It was confirmed that there was a statistically significant difference (p<005) in the amount of change in hair count between the test group and the control group after 8 weeks in the comparison of the amount of change in hair count. Therefore, it is judged that the test sample used in this test helps alleviate hair loss symptoms.
7) 시험 결과7) Test results
도 1 내지 도 7은 인체적용시험 결과를 그래프 또는 사진으로 나타낸 도면이다.Figures 1 to 7 are diagrams showing the results of human application tests in graphs or photographs.
7-1) 연구 대상자 기본 정보 통계 값7-1) Basic information and statistical values of research subjects
7-2) 시험 진행 현황7-2) Test progress status
7-3) 1차 유효성 평가 - 모발수 (도 1 : 주차별 모발수, 도 2 : 모발수 개선율, 도 4 : 시험군 대상자 일부의 사진, 도 5 : 대조군 대상자 일부의 사진, 도 6 : 시험군 대상자 일부의 Folliscope Phtotrichogram, 도 7 : 대조군 대상자 일부의 Folliscope Phtotrichogram)7-3) Primary effectiveness evaluation - Hair count (Figure 1: Weekly hair count, Figure 2: Hair count improvement rate, Figure 4: Photographs of some of the test group subjects, Figure 5: Photos of some of the control group subjects, Figure 6: Test Folliscope Phtotrichogram of some of the group subjects, Figure 7: Folliscope Phtotrichogram of some of the control subjects)
[평균 모발 수(N/㎠) 변화 양상][Average hair count (N/㎠) change pattern]
[모발수 (N/㎠) 측정값 정규성 검정, Ryan-Joiner Normality Test][Hair count (N/㎠) measurement value normality test, Ryan-Joiner Normality Test]
추정치of difference
estimate
[모발수 (N/㎠) 측정값 시험 전 동질성 확인, Welch's t-test][Check homogeneity before testing hair count (N/㎠) measurements, Welch's t-test]
모발수(N/㎠) 측정 결과의 정규성(normality) 여부를 확인한 결과, 모든 측정값의 정규성을 추정할 수 있었다. 또한 시험 시작 전, 시험군과 대조군 연구 대상자 모발수의 동질성을 확인한 결과, 두 그룹간 모발수가 통계적으로 유의한 수준 (p<0.05)의 차이를 갖지 않는 것을 확인하였다. 따라서, 시험군 및 대조군 모발수 측정값의 시험 전후 및 그룹 간 비교는 모수적으로 반복측정분산분석을 통해 분석하였다.As a result of checking the normality of the hair count (N/cm2) measurement results, it was possible to estimate the normality of all measurement values. In addition, before starting the test, the homogeneity of the number of hairs in the test group and the control group was confirmed, and it was confirmed that there was no statistically significant difference (p<0.05) in the number of hairs between the two groups. Therefore, comparisons between the test group and control group hair count measurements before and after the test and between groups were parametrically analyzed using repeated measures analysis of variance.
(N/㎠)hair count
(N/㎠)
[모발수 (N/㎠) 측정값 전후 비교 통계, 반복측정분산분석][Hair count (N/㎠) comparison statistics before and after measurement, repeated measures analysis of variance]
[모발수 (N/㎠) 측정값 통계, 사후검정 (Tukey)] [Hair count (N/㎠) measurement value statistics, post hoc test (Tukey)]
(* 문자를 공유하지 않는 평균들은 통계적으로 유의한(p <0.05) 차이를 가진다)(*Means that do not share a letter have statistically significant (p <0.05) differences)
모발수(N/㎠) 측정 결과의 시험 전후, 변화 정도를 분석한 결과, 시험군의 경우 시험 전과 비교하여 8주차부터 통계적으로 유의한 수준 (p<0.05)으로 모발수가 증가하였다. 이러한 결과는 사후검정 (Tukey)을 통해서도 유의한 것을 확인할 수 있었다.As a result of analyzing the degree of change in the hair count (N/cm2) measurement results before and after the test, the number of hairs in the test group increased at a statistically significant level (p<0.05) from the 8th week compared to before the test. These results were confirmed to be significant through a post hoc test (Tukey).
(Group * week)interaction
(Group * week)
[모발수 (N/㎠) 그룹간 비교 대조 통계, 반복측정분산분석][Hair count (N/㎠) comparison and contrast statistics between groups, repeated measures analysis of variance]
모발수(N/㎠) 측정 결과의 그룹 간 차이를 확인하기 위해, 주차별 모발수에 그룹 간 유의한 차이가 있는지 반복측정분산분석을 통해 검증하였다. 분석결과, 시험군과 대조군의 주차별 모발수 변화 양상을 비교한 그룹간 분석에서 통계적으로 유의한 수준(p<005)의 차이를 확인할 수 있었다. In order to confirm differences between groups in hair count (N/cm2) measurement results, repeated measures analysis of variance was used to verify whether there was a significant difference between groups in weekly hair counts. As a result of the analysis, a statistically significant level (p<005) difference was confirmed in the inter-group analysis comparing the weekly hair count change pattern of the test group and the control group.
[시점 별 모발수 (N/㎠) 측정값의 변화량(△) 정규성 검정, [Test for normality of change (△) in the measured value of hair count (N/㎠) at each time point,
Ryan-Joiner Normality Test]Ryan-Joiner Normality Test]
추정치of difference
estimate
[시점 별 모발수 (N/㎠) 측정값의 변화량(△) 군간 통계 분석, Welch's t-test][Statistical analysis between groups of change in hair count (N/㎠) measurement value (△) at each time point, Welch's t-test]
점추정치of difference
point estimate
[시점 별 모발수 (N/㎠) 측정값의 변화량(△) 군간 통계 분석, [Statistical analysis between groups of change in hair count (N/㎠) measurement value (△) at each time point,
Mann-Whitney U test]Mann-Whitney U test]
시점별 모발수 측정값의 변화량(△)의 시험군과 대조군 간 통계적 유의성을 검정하기 위하여 군간 추가 통계 분석을 실시한 결과, 8주차, 16주 차 및 24주 차 모두 시험군과 대조군간의 변화량이 통계적으로 유의한 수준(p<0.05)의 차이가 있음을 확인할 수 있었다.As a result of conducting additional statistical analysis between groups to test the statistical significance between the test group and the control group in the amount of change (△) in the hair count measurement value at each time point, the change between the test group and the control group at all 8 weeks, 16 weeks, and 24 weeks was statistically significant. It was confirmed that there was a difference at a significant level (p<0.05).
총괄정리하면, 시험 전 시험 시료를 사용할 시험군 및 대조 시료를 사용할 대조군 모발수 간의 초기값 동질성을 분석한 결과, 군간의 통계적으로 유의한 수준(p<0.05)의 차이를 확인할 수 없어, 시험군 및 대조군 간의 동질성을 확인할 수 있었다. Phototrichogram을 통한 모발수(N/㎠) 측정을 통해 시험 전후 변화 정도를 분석한 결과, 시험군의 경우 8주차부터 통계적으로 유의한 수준(p<0.05)으로 모발수가 증가하였다. 또한 그룹간 차이를 확인한 결과, 주차별 모발수 변화 양상을 비교한 그룹간 분석에서 시험군과 대조군 모발수의 주차별 변화양상이 통계적으로 유의한 수준(p<0.05)의 차이를 가지는 것을 확인하였고, 주차별 모발수 변화량 비교에서도 8주 경과 이후 시험군과 대조군 간 모발수 변화량이 통계적으로 유의한 수준(p<0.05)의 차이를 가지는 것을 확인할 수 있었다.In summary, as a result of analyzing the initial value homogeneity between the test group that will use the test sample before the test and the control group that will use the control sample, no statistically significant difference (p<0.05) between the groups could be confirmed, so the test group and homogeneity between the control groups could be confirmed. As a result of analyzing the degree of change before and after the test by measuring the number of hairs (N/cm2) using a phototrichogram, the number of hairs in the test group increased at a statistically significant level (p<0.05) from the 8th week. In addition, as a result of checking the differences between groups, in the inter-group analysis comparing the weekly changes in hair count, it was confirmed that there was a statistically significant difference (p<0.05) between the weekly changes in the test and control group hair counts. , in comparing the amount of change in hair count by week, it was confirmed that there was a statistically significant difference (p<0.05) in the amount of change in hair count between the test group and the control group after 8 weeks.
7-4) 2차 유효성 평가 - 시험자 육안 평가 (도 3)7-4) Secondary effectiveness evaluation - visual evaluation by the tester (Figure 3)
[모발 개선 정도 시험자 육안 평가 평균점수 변화][Change in the average score of the tester’s visual evaluation of the degree of hair improvement]
(3: 매우 좋아짐, 2: 좋아짐, 1: 조금 좋아짐,(3: very much better, 2: better, 1: slightly better,
0: 변화 없음, -1: 조금 나빠짐, -2: 나빠짐, -3: 매우 나빠짐)0: No change, -1: Slightly worse, -2: Worse, -3: Very worse)
시험자 육안 평가 점수의 시험 전후 변화 정도를 분석한 결과, 시험군과 대조군 모두 통계적으로 유의한 수준 (p<0.05)의 차이를 확인할 수 없었다. 그룹 간 경향을 비교한 결과에서도 시험군과 대조군 간 통계적으로 유의한 수준(p<0.05)의 차이를 확인할 수 없었다.As a result of analyzing the degree of change in the examiner's visual evaluation score before and after the test, no statistically significant difference (p<0.05) could be confirmed in both the test and control groups. As a result of comparing trends between groups, no statistically significant difference (p<0.05) was found between the test group and the control group.
7-5) 2차 유효성 평가 - 시험 대상자 설문 평가7-5) Secondary effectiveness evaluation - test subject questionnaire evaluation
풍성해짐hair
enriched
모발수
줄어듦leaving out
hair count
decrease
좋아짐bangs line
getting better
[시험 대상자 설문 평가 정리][Summary of test subject survey evaluation]
연구 대상자 설문에 의한 호전도 평가점수는 정수리 모발의 풍성함, 모발 탈락 정도, 앞머리선 개선 항목으로 평가되었다. 시험군의 경우, 연구 대상자의 평가 결과 모든 지표에서 24주차부터 통계적으로 유의한 수준(p<0.05)의 개선된 변화를 확인할 수 있었다. 대조군의 경우, 모발의 풍성함 개선, 모발 탈락 정도 개선은 24주차부터, 앞머리선 개선은 16주차부터 통계적으로 유의한 수준(p<0.05)의 변화를 확인할 수 있었으나, 육안평가 점수가 감소하는 경향을 보였다. 그룹간 변화 양상을 확인한 결과, 시험군과 대조군 모두 평가 점수에서 통계적으로 유의한 수준(p<0.05)의 차이를 확인할 수 있었고 시점 별 군간 통계 분석을 통해 확인한 결과에서도 모발의 풍성함, 모발의 탈락 정도 및 앞머리선 개선 항목 모두 16주차와 24주차에서 통계적으로 유의한 수준(p<0.05)의 차이를 확인할 수 있었다.The improvement evaluation score based on the survey of research subjects was evaluated in terms of the abundance of crown hair, the degree of hair loss, and the improvement of the frontal hairline. In the case of the test group, as a result of the study subjects' evaluation, statistically significant (p<0.05) improved changes were confirmed from week 24 in all indicators. In the case of the control group, statistically significant changes (p<0.05) were observed in the improvement of hair abundance and hair loss from the 24th week, and in the improvement of the frontal hairline from the 16th week, but the visual evaluation score tended to decrease. It seemed. As a result of checking the pattern of change between groups, a statistically significant level (p<0.05) difference was confirmed in the evaluation scores for both the test group and the control group, and the results confirmed through statistical analysis between groups at each time point also showed the abundance of hair and the degree of hair loss. In both the frontal line improvement items, statistically significant differences (p<0.05) were confirmed between the 16th and 24th weeks.
지금까지 본 발명에 대하여 바람직한 실시예를 중심으로 살펴보았다.So far, the present invention has been examined with a focus on preferred embodiments.
본 명세서에 기재된 실시예와 도면에 도시된 구성은 본 발명의 가장 바람직한 하나의 실시예에 관련된 것이고, 본 발명의 기술적 사상을 모두 대변하는 것은 아니므로, 이들을 대체할 수 있는 다양한 균등물과 변형된 예들이 있을 수 있음을 이해하여야 한다.The embodiments described in this specification and the configurations shown in the drawings are related to one of the most preferred embodiments of the present invention, and do not represent the entire technical idea of the present invention, so various equivalents and modifications can be used to replace them. It should be understood that there may be examples.
따라서 본 발명은 제시되는 실시예에 한정되지 않으며, 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자에 의하여 본 발명의 기술 사상과 아래에 기재될 특허청구범위에 기재된 기술사상의 균등한 범위 내에서 다양한 수정 및 변경이 가능한 실시예가 있을 수 있다.Therefore, the present invention is not limited to the presented embodiments, and is within the equivalent scope of the technical idea of the present invention and the technical idea described in the patent claims below, as will be recognized by those skilled in the art to which the present invention pertains. There may be embodiments in which various modifications and changes are possible.
Claims (4)
나이아신아마이드, 판테놀, 바이오틴 및 멘톨을 추가로 포함하는 것을 특징으로 하는, 탈모 예방 및 발모 촉진을 위한 외용제 조성물.In claim 1,
A composition for external application for preventing hair loss and promoting hair growth, characterized in that it additionally contains niacinamide, panthenol, biotin and menthol.
상기 쑥부쟁이 캘러스의 배양액은 20.58중량부, 나이아신아마이드은 0.3 중량부, 판테놀은 0.25 중량부, 바이오틴은 0.05 중량부 및 멘톨 0.1 중량부로 포함되는 것을 특징으로 하는, 탈모 예방 및 발모 촉진을 위한 외용제 조성물.In claim 2,
An external composition for preventing hair loss and promoting hair growth, characterized in that it contains 20.58 parts by weight of the callus culture medium, 0.3 parts by weight of niacinamide, 0.25 parts by weight of panthenol, 0.05 parts by weight of biotin, and 0.1 part by weight of menthol.
메틸프로판다이올, 다이프로필렌글라이콜, 글리세레스-25피씨에이아이소스테아레이트, 1,2-헥산다이올, 하이드록시아세토페논, 하이드롤라이즈드인삼사포닌, 베타인살리실레이트, 트로메타민, 부틸렌글라이콜, 구주소나무잎오일, 아미노레불리닉애씨드에이치씨엘, 프로판다이올, 카프릴릴글라이콜, 윈터체리뿌리추출물, 시카카이열매추출물, 님잎추출물, 인디안구스베리열매추출물, 하수오뿌리추출물, 약모밀추출물, 울금뿌리추출물, 병풀추출물, 주아나무껍질추출물, 카퍼트라이펩타이드-1, 헥사펩타이드-2, 에스에이치-올리고펩타이드-1 및 에스에이치-폴리펩타이드-1을 추가로 포함하는 것을 특징으로 하는, 탈모 예방 및 발모 촉진을 위한 외용제 조성물.
In claim 2,
Methylpropanediol, dipropylene glycol, glycereth-25PCA isostearate, 1,2-hexanediol, hydroxyacetophenone, hydrolyzed ginseng saponin, betaine salicylate, tromethamine, Butylene glycol, Kuju pine leaf oil, Aminolevulinic Acid HCL, propanediol, caprylyl glycol, winter cherry root extract, Shikakai fruit extract, neem leaf extract, Indian gooseberry fruit extract, Haushu root extract, Hair loss, characterized in that it further comprises medicinal wheat extract, turmeric root extract, centella asiatica extract, jua bark extract, copper tripeptide-1, hexapeptide-2, SH-oligopeptide-1 and SH-polypeptide-1. A composition for external use for prevention and hair growth promotion.
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