BR102017003313B1 - ANTI-DANDRUFF COMPOSITION AND METHOD FOR THE PREVENTION, REDUCTION OR TREATMENT OF DANDRUFF - Google Patents
ANTI-DANDRUFF COMPOSITION AND METHOD FOR THE PREVENTION, REDUCTION OR TREATMENT OF DANDRUFF Download PDFInfo
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- BR102017003313B1 BR102017003313B1 BR102017003313-9A BR102017003313A BR102017003313B1 BR 102017003313 B1 BR102017003313 B1 BR 102017003313B1 BR 102017003313 A BR102017003313 A BR 102017003313A BR 102017003313 B1 BR102017003313 B1 BR 102017003313B1
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- Prior art keywords
- composition
- dandruff
- antidandruff
- scalp
- extract
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- 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
- A61Q5/006—Antidandruff preparations
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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
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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
- A61K8/36—Carboxylic acids; Salts or anhydrides thereof
- A61K8/368—Carboxylic acids; Salts or anhydrides thereof with carboxyl groups directly bound to carbon atoms of aromatic rings
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- A—HUMAN NECESSITIES
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
- A61K8/85—Polyesters
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- A—HUMAN NECESSITIES
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
- A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
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- A—HUMAN NECESSITIES
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- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
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Abstract
a invenção refere-se uma composição cosmética anticaspa compreendendo um complexo seborregulador que tem uma combinação de pelo menos um extrato de epilobium fleischeri, um 4-terpineol, uma goma de caesalpinia spinosa, um extrato de casca de salix alba e um bisabolol. apresenta ainda composições tópicas compreendendo um complexo seborregulador, preferencialmente em combinação com outros ativos para tratamento de pele, como um ácido salicílico, um polisorbato ou uma mistura de ambos. a invenção também prevê o uso de composições por meio da aplicação tópica, à pele, preferencialmente, ao couro cabeludo.The invention relates to an anti-dandruff cosmetic composition comprising a sebum-regulating complex that has a combination of at least one epilobium fleischeri extract, a 4-terpineol, a caesalpinia spinosa gum, a salix alba bark extract and a bisabolol. It also presents topical compositions comprising a sebum-regulating complex, preferably in combination with other active ingredients for skin treatment, such as salicylic acid, polysorbate or a mixture of both. The invention also provides for the use of compositions through topical application to the skin, preferably the scalp.
Description
[1] A presente invenção refere-se uma composição cosmética anticaspa compreendendo um complexo seborregulador que tem uma combinação de pelo menos um extrato de Epilobium fleischeri, um 4-terpineol, uma goma de Caesalpinia spinosa, um extrato de casca de Salix alba e um Bisabolol. Apresenta ainda composições tópicas compreendendo um complexo seborregulador, preferencialmente em combinação com outros ativos para tratamento de pele, como um ácido salicílico, um polisorbato ou uma mistura de ambos. A invenção também prevê o uso de composições por meio da aplicação tópica, à pele, preferencialmente, ao couro cabeludo.[1] The present invention relates to a cosmetic antidandruff composition comprising a seborregulatory complex which has a combination of at least an extract of Epilobium fleischeri, a 4-terpineol, a gum of Caesalpinia spinosa, a bark extract of Salix alba and a Bisabolol. It also presents topical compositions comprising a seborregulatory complex, preferably in combination with other actives for skin treatment, such as salicylic acid, a polysorbate or a mixture of both. The invention also provides for the use of compositions by topical application to the skin, preferably to the scalp.
[2] É sabido que a caspa está associada a alterações no estado da pele do couro cabeludo. Constatou-se que a pele do couro cabeludo com caspa apresenta alterações no estado do couro cabeludo e tem um caráter multifatorial.[2] It is known that dandruff is associated with changes in the condition of the skin on the scalp. It was found that the scalp skin with dandruff presents changes in the condition of the scalp and has a multifactorial character.
[3] A principal, se não for a única estratégia de intervenção utilizada atualmente no mercado para o tratamento da caspa é a aplicação tópica de antifúngicos tais como piritiona de zinco (ZnPTO), octopirox e quetoconazol que são normalmente aplicados a partir de um xampu. Esses agentes antifúngicos removem (ou pelo menos reduzem o nível de) Malassezia do couro cabeludo, e conferem um tratamento eficaz da caspa.[3] The main, if not the only intervention strategy currently used in the market for the treatment of dandruff is the topical application of antifungals such as zinc pyrithione (ZnPTO), octopirox and ketoconazole that are normally applied from a shampoo . These antifungal agents remove (or at least reduce the level of) Malassezia from the scalp, and provide an effective treatment for dandruff.
[4] No entanto, composições tópicas compreendendo antifúngicos podem causar diversos efeitos colaterais indesejados. Por exemplo, composições medicamentosas tópicas de cetocnazol utilizadas para o tratamento de micoses e caspa pode causar efeitos colaterais como sensação de ardência local, coceira ou dermatite de contato (devido à irritação ou alergia) nas áreas expostas., além de ressecamento dos cabelos. Pode ocorrer também a descoloração dos cabelos, principalmente naqueles pacientes com cabelos grisalhos ou que submetam os cabelos à ação de substâncias químicas (tinturas, descolorações, permanentes, etc.).[4] However, topical compositions comprising antifungals can cause a number of unwanted side effects. For example, topical ketocnazole drug compositions used to treat mycoses and dandruff can cause side effects such as local burning, itching or contact dermatitis (due to irritation or allergy) in exposed areas, in addition to dryness of the hair. Hair discoloration can also occur, especially in those patients with gray hair or who submit their hair to the action of chemical substances (dyes, discolorations, perms, etc.).
[5] Dessa forma há a necessidade de formulações cosméticas com baixas concentrações de ativos sendo capaz de proporcionar diversos benefícios em conjunto para o controle da oleosidade capilar ou tratamento da caspa, tais como a redução significativa na manifestação da caspa, alívio da coceira pela redução da irritação do couro cabeludo e redução da recorrência de caspas entre uma lavagem em outra, após poucas aplicações do produto, sem gerar efeitos adversos indesejados.[5] Thus, there is a need for cosmetic formulations with low concentrations of actives, being able to provide several benefits together for the control of capillary oiliness or treatment of dandruff, such as a significant reduction in the manifestation of dandruff, relief from itching by reducing scalp irritation and reduction in the recurrence of dandruff between one wash and another, after a few applications of the product, without generating unwanted adverse effects.
[6] Embora clinicamente provado que são eficazes no tratamento dos sintomas clínicos da caspa durante um período de duas a quatro semanas, persiste a necessidade de tratar os sintomas principais da caspa de modo mais eficaz e rápido. Os principais sintomas da caspa são escamas visíveis de pele no cabelo e nos ombros e prurido do couro cabeludo. O prurido do couro cabeludo é percebido como um problema particular em certas partes do mundo, por exemplo, ele é o principal sintoma da caspa na China, no Sudeste Asiático e na índia.[6] Although clinically proven to be effective in treating the clinical symptoms of dandruff over a two to four week period, there remains a need to treat the main symptoms of dandruff more effectively and quickly. The main symptoms of dandruff are visible scales of skin on the hair and shoulders and itching of the scalp. Scalp itching is perceived as a particular problem in certain parts of the world, for example it is the main symptom of dandruff in China, Southeast Asia and India.
[7] Portanto, além de tratar os sinais clínicos da caspa, persiste a necessidade de conferir um alívio rápido ao prurido do couro cabeludo para os indivíduos que sofrem de caspa.[7] Therefore, in addition to treating the clinical signs of dandruff, there remains a need to provide rapid relief from scalp itching for individuals suffering from dandruff.
[8] Sem se ater à teoria, descobriu-se que certas composições fornecem uma atividade antisseborreica, de uso tópico, compreendendo uma combinação de ativos para tratamento da caspa, particularmente um complexo seborregulador compreendendo pelo menos uma combinação de um extrato de Epilobium fleischeri, um 4-terpineol, uma goma de Caesalpinia spinosa, um extrato de casca de Salix alba e um Bisabolol, podem tanto agir contra a caspa, como reverter uma condição de caspa.[8] Without being bound by theory, it has been found that certain compositions provide antiseborrheic activity, for topical use, comprising a combination of actives for the treatment of dandruff, particularly a seborregulatory complex comprising at least one combination of an extract of Epilobium fleischeri, a 4-terpineol, a Caesalpinia spinosa gum, a Salix alba bark extract and a Bisabolol can either act against dandruff or reverse a dandruff condition.
[9] O documento US 2016089310 AA de DSM IP ASSETS BV, depositado em 14/05/2014, revela uma composição tópica que compreende pelo menos um agente de controle de sebo, um agente de descamação da pele e / ou um agente de aumento de colágeno. Revela ainda que o agente de controle de sebo é o extrato de Epilobium fleischeri (ALPAFLOR) ou Vitamina B6 (piridoxina). Revela ainda que o agente de esfoliação da pele é o ácido salicílico. Contudo, falha em revelar um complexo seborregulador em composição cosmética anticaspa.[9] Document US 2016089310 AA of DSM IP ASSETS BV, filed on 05/14/2014, discloses a topical composition comprising at least one sebum control agent, a skin peeling agent and/or an augmenting agent of collagen. It also reveals that the sebum control agent is the extract of Epilobium fleischeri (ALPAFLOR) or Vitamin B6 (pyridoxine). It also reveals that the skin exfoliating agent is salicylic acid. However, it fails to reveal a seboregulatory complex in an anti-dandruff cosmetic composition.
[10] ES 2517790 BA de LACER, S.A., depositado em 30/04/2013, reivindica combinação que compreende climbazole, extracto de sauce e terpinen-4-ol. Na reivindicação 12, revela uma composição tópica farmacêutica ou cosmética que compreende (i) climbazol; (ii) extrato de sauce branco; (iii) terpinen-4-ol; (iv) opcionalmente um ou mais agentes antiseborreicos; (v) opcionalmente um ou mais agentes antiprurido; (vi) um ou mais excipientes. No exemplo 3, revela o uso combinado de 4-terpinen-ol, extrato de Salix Alba e Ácido salicílico. Na reivindicação 14, revela que a composição é um xampu. No parágrafo [0185] revela o uso combinado de (1) Trikenol Plus (com 71,5% de 2-metilpropano-1,3-diol, 18,5% de terpinen-4-ol, 7,5 % de ácido salicilico e 2,5 % de extrato de Salix Alba; combinado com Pantenol (Panthenol); e álcool etílico. Contudo, o documento falha em revelar um complexo seborregulador em composição cosmética anticaspa.[10] ES 2517790 BA by LACER, S.A., filed on 04/30/2013, claims a combination comprising climbazole, sauce extract and terpinen-4-ol. In claim 12, it discloses a topical pharmaceutical or cosmetic composition comprising (i) climbazol; (ii) white sauce extract; (iii) terpinen-4-ol; (iv) optionally one or more antiseborrheic agents; (v) optionally one or more antipruritic agents; (vi) one or more excipients. In example 3, it reveals the combined use of 4-terpinen-ol, Salix Alba extract and salicylic acid. In claim 14, it discloses that the composition is a shampoo. In paragraph [0185] it discloses the combined use of (1) Trikenol Plus (with 71.5% 2-methylpropane-1,3-diol, 18.5% terpinen-4-ol, 7.5% salicylic acid and 2.5% Salix Alba extract, combined with Panthenol (Panthenol) and ethyl alcohol, however, the document fails to reveal a seborregulatory complex in an anti-dandruff cosmetic composition.
[11] A presente invenção apresenta uma composição cosmética anticaspa, compreendendo um complexo seborregulador compreendendo pelo menos um: - extrato de Epilobium fleischeri - 4-terpineol - Goma de Caesalpinia spinosa - Extrato de casca de Salix alba - Bisabolol[11] The present invention provides an anti-dandruff cosmetic composition, comprising a seborregulatory complex comprising at least one: - Epilobium fleischeri extract - 4-terpineol - Caesalpinia spinosa gum - Salix alba bark extract - Bisabolol
[12] Adicionalmente, a composição anticaspa compreende um ácido salicílico, um bisabolol, ou uma mistura de ambos.[12] Additionally, the antidandruff composition comprises a salicylic acid, a bisabolol, or a mixture of both.
[13] Preferencialmente, complexo seborregulador da composição anticaspa, objeto da presente invenção, compreende 0,01% a 3% de extrato de Epilobium fleischeri, de 0,001% a 0,1% de 4-terpineol, de 0,001% a 1% de goma de Caesalpinia spinosa, de 0,00001% a 1% de extrato de casca de Salix alba e de 0,1% a 3% de bisabolol, em peso total da composição.[13] Preferably, the seborregulatory complex of the antidandruff composition, object of the present invention, comprises 0.01% to 3% of Epilobium fleischeri extract, from 0.001% to 0.1% of 4-terpineol, from 0.001% to 1% of Caesalpinia spinosa gum, from 0.00001% to 1% of Salix alba bark extract and from 0.1% to 3% of bisabolol, in total weight of the composition.
[14] A composição é particularmente útil para o tratamento do cabelo e couro cabeludo, mais particularmente para o tratamento da caspa. Descrição das figuras[14] The composition is particularly useful for the treatment of hair and scalp, more particularly for the treatment of dandruff. Description of figures
[15] A Fig. 1 revela o Gráfico 1 com o valor médio da classificação da intensidade da caspa obtido na análise sensorial por eficácia clinica.[15] Fig. 1 reveals Graph 1 with the mean value of the classification of dandruff intensity obtained in the sensory analysis by clinical efficacy.
[16] A Fig. 2 revela o Gráfico 2 com a porcentagem de participante da pesquisa que perceberam a eficácia do xampu em cada atributo avaliado na análise sensorial por eficácia percebida.[16] Fig. 2 reveals Graph 2 with the percentage of research participants who perceived the effectiveness of the shampoo in each attribute evaluated in the sensory analysis by perceived effectiveness.
[17] A Fig. 3 revela o Gráfico 3 com a porcentagem de participante da pesquisa que perceberam a agradabilidade do xampu em cada atributo avaliado na análise sensorial por eficácia percebida.[17] Fig. 3 reveals Graph 3 with the percentage of research participants who perceived the pleasantness of the shampoo in each attribute evaluated in the sensory analysis by perceived effectiveness.
[18] Exceto onde definido o contrário, todos os termos técnicos e científicos usados na presente invenção têm o significado comumente compreendido pelo versado na técnica à qual pertence a invenção. Todas as publicações, pedidos de patentes, patentes e outras referências mencionadas na presente invenção estão aqui incorporadas em sua inteireza a título de referência. Exceto onde indicado o contrário, porcentagem refere-se a porcentagem em peso total (isto é, %(peso/peso) total da composição).[18] Unless otherwise defined, all technical and scientific terms used in the present invention have the meaning commonly understood by one of ordinary skill in the art to which the invention belongs. All publications, patent applications, patents and other references mentioned in the present invention are incorporated herein by reference in their entirety. Unless otherwise noted, percentage refers to the total weight percentage (ie, total %(weight/weight) of the composition).
[19] Os inventores descobriram, surpreendentemente, que com o uso de uma composição anticaspa compreendendo um complexo seborregulador em baixa concentração dos ativos extrato de Epilobium fleischeri, um 4-terpineol, uma goma de Caesalpinia spinosa, um extrato de casca de Salix alba e um Bisabolol é capaz de agir de maneira eficaz no controle e redução da manifestação da caspa, sem causar efeitos adversos indesejados.[19] The inventors surprisingly found that with the use of an anti-dandruff composition comprising a seborregulatory complex in low concentration of the actives Epilobium fleischeri extract, a 4-terpineol, a Caesalpinia spinosa gum, a Salix alba bark extract and Bisabolol is able to act effectively in controlling and reducing the manifestation of dandruff, without causing unwanted adverse effects.
[20] A presente invenção, assim, refere-se a uma composição anticaspa, compreendendo um complexo seborregulador compreendendo pelo menos um: - extrato de Epilobium fleischeri - 4-terpineol - Goma de Caesalpinia spinosa - Extrato de casca de Salix alba - Bisabolol[20] The present invention thus relates to an anti-dandruff composition comprising a seborregulatory complex comprising at least one: - Epilobium fleischeri extract - 4-terpineol - Caesalpinia spinosa gum - Salix alba bark extract - Bisabolol
[21] Em uma concretização preferencial, a presente invenção refere-se a uma composição anticaspa, compreendendo de 0,01% a 3% de extrato de Epilobium fleischeri, de 0,001% a 0,1% de 4-terpineol, de 0,001% a 1% de goma de Caesalpinia spinosa, de 0,00001% a 1% de extrato de casca de Salix alba e de 0,1% a 3% de bisabolol, em peso total da composição. A composição anticaspa compreende, ainda, de 0,01% a 5% de um complexo seborregulador, de 0,1% a 3% de um ácido salicílico e de 0,001% a 1% de um polisorbato, em peso total da composição, em associação com um veículo cosmeticamente aceitável.[21] In a preferred embodiment, the present invention relates to an anti-dandruff composition, comprising from 0.01% to 3% of Epilobium fleischeri extract, from 0.001% to 0.1% of 4-terpineol, from 0.001% to 1% of Caesalpinia spinosa gum, from 0.00001% to 1% of Salix alba bark extract and from 0.1% to 3% of bisabolol, in total weight of the composition. The anti-dandruff composition further comprises from 0.01% to 5% of a seborregulatory complex, from 0.1% to 3% of a salicylic acid and from 0.001% to 1% of a polysorbate, by total weight of the composition, in association with a cosmetically acceptable vehicle.
[22] Em particular a composição de acordo com a presente invenção é aplicável topicamente ao cabelo e couro cabeludo para reduzir a oleosidade e prevenira caspa.[22] In particular the composition according to the present invention is topically applicable to hair and scalp to reduce oiliness and prevent dandruff.
[23] A composição anticaspa, de acordo com a presente invenção, preferencialmente compreende de 1% a 5% de um complexo seborregulador, de 1% a 50% de tensoativos, de 1% a 10% de espessantes, de 1% a 10% de umectantes, de 1% a 20% de emolientes, em peso total da composição. A composição anticaspa pode compreender ainda de 1% a 10% de ativos anticaspa, tais como piritionato de zinco, climbazole, cetoconazol, octopirox, piroctone olamina, hidróxido de piridoxina, zinco PCA e outros, em peso total da composição.[23] The antidandruff composition, according to the present invention, preferably comprises from 1% to 5% of a seborregulatory complex, from 1% to 50% of surfactants, from 1% to 10% of thickeners, from 1% to 10 % humectants, 1% to 20% emollients, by total weight of the composition. The antidandruff composition may further comprise from 1% to 10% of antidandruff actives such as zinc pyrithione, climbazole, ketoconazole, octopirox, piroctone olamine, pyridoxine hydroxide, zinc PCA and others, by total weight of the composition.
[24] Mais preferencialmente, as composições compreendem o complexo seborregulador nas concentrações de 0,01% a 2%, em peso total da composição.[24] More preferably, the compositions comprise the seborregulatory complex in concentrations of 0.01% to 2%, by total weight of the composition.
[25] Adicionalmente, a composição anticaspa de acordo com a presente invenção pode compreender ingredientes selecionados dentre ajustador de pH, ativo anticaspa, condicionante, conservante, formador de filme, fragrância, opacificante, quelante, solubilizante e solventes.[25] Additionally, the antidandruff composition according to the present invention may comprise ingredients selected from pH adjuster, antidandruff active, conditioner, preservative, film former, fragrance, opacifier, chelator, solubilizer and solvents.
[26] A composição de acordo com a invenção é preferivelmente apropriada para administração tópica à pele, em especial, ao couro cabeludo.[26] The composition according to the invention is preferably suitable for topical administration to the skin, in particular the scalp.
[27] As administrações tópicas de acordo com a invenção são na forma de um creme, um gel, uma loção, um leite, um óleo, um unguento, uma espuma, uma pasta, um soro, uma pomada ou um xampu. Preferencialmente na forma de um xampu.[27] Topical administrations according to the invention are in the form of a cream, a gel, a lotion, a milk, an oil, an ointment, a foam, a paste, a serum, an ointment or a shampoo. Preferably in the form of a shampoo.
[28] Entre as concretizações de composições tópicas preferidas, em especial, tem-se um xampu anticaspa, compreendendo de 0,01% a 3% de extrato de Epilobium fleischeri, de 0,001% a 0,1% de 4- terpineol, de 0,001% a 1% de goma de Caesalpinia spinosa, de 0,00001% a 1% de extrato de casca de Salix alba e de 0,1% a 3% de bisabolol, de 0,01% a 5% de um complexo seborregulador, de 0,1% a 3% de um ácido salicílico, de 0,01% a 1% de um polisorbato, em peso total da composição, em associação com um veículo cosmeticamente aceitável.[28] Among the preferred embodiments of topical compositions, in particular, there is an anti-dandruff shampoo, comprising from 0.01% to 3% of Epilobium fleischeri extract, from 0.001% to 0.1% of 4-terpineol, of 0.001% to 1% Caesalpinia spinosa gum, 0.00001% to 1% Salix alba bark extract and 0.1% to 3% bisabolol, 0.01% to 5% of a seborregulatory complex from 0.1% to 3% of a salicylic acid, from 0.01% to 1% of a polysorbate, by total weight of the composition, in association with a cosmetically acceptable vehicle.
[29] Além disso, as composições anticaspa que podem ser usadas de acordo com a invenção podem ser mais ou menos fluidas, passíveis de aplicação ao couro cabeludo e podem ter a aparência de um creme branco ou colorido, uma pomada, um leite, uma loção, um soro, uma pasta ou uma espuma. Elas podem, opcionalmente, ser aplicadas à pele na forma de aerossol. Elas também podem estar na forma sólida, por exemplo na forma de bastão.[29] Furthermore, the anti-dandruff compositions which can be used according to the invention may be more or less fluid, capable of being applied to the scalp and may have the appearance of a white or colored cream, an ointment, a milk, a lotion, a serum, a paste or a foam. They can optionally be applied to the skin in the form of an aerosol. They can also be in solid form, for example in stick form.
[30] Para aplicação local ao cabelo ou ao couro cabeludo, a composição pode estar na forma de soluções aquosas, alcoólicas ou aquosas- alcoólicas; na forma de cremes, géis, emulsões ou espumas; na forma de composições de aerossóis também compreendendo um propulsor sob pressão.[30] For local application to the hair or scalp, the composition can be in the form of aqueous, alcoholic or aqueous-alcoholic solutions; in the form of creams, gels, emulsions or foams; in the form of aerosol compositions also comprising a propellant under pressure.
[31] A composição de acordo com a invenção pode ser aplicada ao cabelo ou o couro cabeludo, preferivelmente diariamente ou várias vezes ao dia. A aplicação pode, por exemplo, ser repetida cada dia sobre um período variável de acordo com os efeitos desejados, geralmente de imediatos, mas pode ser prolongada ou seguida continuamente.[31] The composition according to the invention can be applied to the hair or the scalp, preferably daily or several times a day. The application can, for example, be repeated each day over a variable period according to the desired effects, usually immediate, but it can be prolonged or continued continuously.
[32] A presente invenção traz também um método de tratamento de caspa, o dito método compreendendo a aplicação de uma composição anticaspa compreendendo um complexo seborregulador à pele em necessidade de tratamento caracterizado por compreender de 0,01% a 3% de extrato de Epilobium fleischeri, de 0,001% a 0,1% de 4-terpineol, de 0,001% a 1% de goma de Caesalpinia spinosa, de 0,00001% a 1% de extrato de casca de Salix alba e de 0,1% a 3% de bisabolol.[32] The present invention also provides a method of treating dandruff, said method comprising the application of an anti-dandruff composition comprising a seborregulatory complex to the skin in need of treatment characterized by comprising from 0.01% to 3% of Epilobium extract fleischeri, from 0.001% to 0.1% of 4-terpineol, from 0.001% to 1% of Caesalpinia spinosa gum, from 0.00001% to 1% of Salix alba bark extract and from 0.1% to 3 % bisabolol.
[33] O processo de formulação foi como descrito a seguir:[33] The formulation process was as follows:
[34] No tanque principal adicionar o EDTA DISSÓDICO. Adicionar COPOLÍMEROS DE ACRILATO Adicionar LAURILÉTER SULFATO DE SÓDIO. Homogeneizar. Em um tanque auxiliar adicionar parte do LAURILÉTER SULFATO DE SÓDIO / LAURIL ÉTER SULFOSSUCCINATO DISSÓDICO e misturar com a PIROCTONA OLAMINA. Transferir para tanque principal. Homogeneizar. No tanque auxiliar adicionar METIL GLUCETE-20, LAURILÉTER SULFATO DE SÓDIO / LAURIL ÉTER SULFOSSUCCINATO DISSÓDICO e o AC. SALICÍLICO. Aquecer 40-80C. Transferir para tanque principal, homogeneizar. Adicionar a solução de HIDRÓXIDO DE SÓDIO para correção de pH. Aquecer tanque principal 30-80°C. Adicionar DIOLEATO DE METILGLICOSE PEG-120, COCOANFOACETATO DE SÓDIO; CAPRILATO DE GLICERILA e POLIQUATERNIUM 10. Homogeneizar. No tanque auxiliar adicionar a água e LAURILÉTER SULFATO DE SÓDIO / COCOAMIDOPROPIL BETAÍNA e DIESTEARATO GLICOL. Homogeneizar. Transferir para tanque principal. Resfriar. No tanque auxiliar adicionar água e CLORIDRATO DE PIRIDOXINA, PCA Zn, PANTENOL E LANOLINA PEG 75. Homogeneizar. Transferir para tanque principal. Homogeneizar. No tanque auxiliar adicionar fragrância e PPG-1-PEG-9 LAURIL GLICOL ÉTER. Transferir para tanque principal. Homogeneizar. Adicionar diretamente ao tanque principal EXTRATO DE EPILOBIUM FLEISCHERI / GLICERINA / ÁGUA / ÁCIDO CÍTRICO / SORBATO DE POTÁSSIO; BISABOLOL; HIDROXIMETOXIFENIL DECANONA; ÁGUA / GLICERINA / METILPROPANODIOL / POLISORBATO 80 / 4-TERPINEOL / GOMA DE CAESALPINIA SPINOSA / EXTRATO DE CASCA DE SALIX ALBA / SORBATO DE POTÁSSIO / BENZOATO DE SÓDIO / GLUCONOLACTONA / GLUCONATO DE CÁLCIO E DMDM-HIDANTOÍNA; LAURETH 2. Homogeneizar. Corrigir o pH se necessário. Homogeneizar.[34] In the main tank add DISODIUM EDTA. Add ACRYLATE COPOLYMERS Add SODIUM LAURYLETHER SULFATE. Homogenize. In an auxiliary tank, add part of the SODIUM SULPHATE LAURILETER / DISODIUM LAURYL ETHER SULFOSUCCINATE and mix with PYROCTONE OLAMINE. Transfer to main tank. Homogenize. In the auxiliary tank add METHYL GLUCETE-20, SODIUM LAURILETER SULFATE / DISODIUM LAURIL ETHER SULFOSSUCCINATE and the AC. SALICYLIC. Heat 40-80C. Transfer to main tank, mix. Add SODIUM HYDROXIDE solution for pH correction. Heat main tank 30-80°C. Add PEG-120 METHYLGLYCOSE DIOLEATE, SODIUM COCOAMPHOACETATE; GLYCERYL CAPRYLATE and POLYQUATERNIUM 10. Homogenize. In the auxiliary tank add water and SODIUM SULFATE LAURILÉTER / COCOAMIDOPROPIL BETAINE and GLYCOL DISEARATE. Homogenize. Transfer to main tank. Cool down. In the auxiliary tank add water and PYRIDOXINE CHLORIDATE, PCA Zn, PANTENOL AND LANOLIN PEG 75. Homogenize. Transfer to main tank. Homogenize. In the auxiliary tank add fragrance and PPG-1-PEG-9 LAURIL GLYCOL ETHER. Transfer to main tank. Homogenize. Add directly to main tank EPILOBIUM FLEISCHERI EXTRACT / GLYCERINE / WATER / CITRIC ACID / POTASSIUM SORBATE; BISABOLOL; HYDROXYMETHOXIFENYL DECANONE; WATER / GLYCERIN / METHYLPROPANEDIOL / POLYSORBATE 80 / 4-TERPINEOL / CAESALPINIA SPINOSA GUM / SALIX ALBA BARK EXTRACT / POTASSIUM SORBATE / SODIUM BENZOATE / GLUCONOLACTONE / CALCIUM-ALCIUM GLUCONATE; LAURETH 2. Homogenize. Correct pH if necessary. Homogenize.
[35] Foi realizada uma avaliação da eficácia por análise sensorial por eficácia clínica e percebida com o objetivo de avaliar a redução da caspa após 17 a 20 aplicações do produto de acordo com o Exemplo 1.[35] An evaluation of the efficacy was carried out by sensory analysis for clinical and perceived efficacy in order to assess the reduction in dandruff after 17 to 20 applications of the product according to Example 1.
[36] O Gráfico 1 (Figura 1) ilustra os valores médios da intensidade de caspa obtidos durante o estudo.[36] Graph 1 (Figure 1) illustrates the mean values of dandruff intensity obtained during the study.
[37] Em relação ao número de aplicações onde houve a percepção da redução de caspas pelos participantes da pesquisa, os seguintes resultados foram obtidos: 83,3% das participantes da pesquisa observaram que o xampu (Exemplo 1) reduziu a caspa entre a 1a e a 6a lavagem. 6,7% das participantes da pesquisa observaram que o xampu (Exemplo 1) reduziu a caspa entre a 7a e a 10° lavagem.[37] Regarding the number of applications where there was a perception of dandruff reduction by the research participants, the following results were obtained: 83.3% of the research participants observed that the shampoo (Example 1) reduced dandruff between the 1st and the 6th wash. 6.7% of survey participants noted that shampoo (Example 1) reduced dandruff between the 7th and 10th wash.
[38] Outro sintoma evidente da caspa é a coceira no couro cabeludo. Assim, clinicamente foi realizada uma avaliação da coceira no início do estudo e após 17 a 20 aplicações do xampu (Exemplo 1).[38] Another obvious symptom of dandruff is itchy scalp. Thus, clinically an evaluation of the itching was performed at the beginning of the study and after 17 to 20 applications of the shampoo (Example 1).
[39] De acordo com os resultados obtidos foi constatado que 93,3% dos participantes da pesquisa incluídos possuíam coceira, sendo que aproximadamente 17,9% dos participantes da pesquisa apresentavam coceira leve, 60,7% moderada e 21,4% intensa.[39] According to the results obtained, it was found that 93.3% of the survey participants included had itching, with approximately 17.9% of the survey participants having mild itching, 60.7% moderate and 21.4% severe .
[40] Após 17 a 20 aplicações do xampu, 57,1% dos participantes da pesquisa notaram diminuição da coceira, 39,3% notaram que a coceira foi eliminada e 3,6% não notaram nenhuma alteração.[40] After 17 to 20 applications of the shampoo, 57.1% of survey participants noted decreased itching, 39.3% noted that the itching was eliminated, and 3.6% noted no change.
[41] Em relação ao número de aplicações onde houve a percepção da redução da coceira do couro cabeludo, pelos participantes da pesquisa que apresentavam o sintoma no início do estudo, os seguintes resultados foram obtidos: 82,2% dos participantes da pesquisa observaram a redução da coceira do couro cabeludo entre a 1a e a 6a lavagem. 17,8% dos participantes da pesquisa observaram a redução da coceira do couro cabeludo entre a 7a e a 10° lavagem.[41] Regarding the number of applications where there was a perception of reduction in scalp itching, by the research participants who had the symptom at the beginning of the study, the following results were obtained: 82.2% of the research participants observed the reduction of itchy scalp between 1st and 6th wash. 17.8% of survey participants noted a reduction in scalp itching between the 7th and 10th wash.
[42] Os Gráficos 2 e 3 (Figuras 2 e 3) ilustram o percentual de participante da pesquisa que perceberam a eficácia e agradabilidade do xampu.[42] Graphs 2 and 3 (Figures 2 and 3) illustrate the percentage of research participants who perceived the effectiveness and pleasantness of the shampoo.
[43] De acordo com os resultados obtidos foi possível constatar que: - Análise sensorial por eficácia clínica: o xampu (Exemplo 1) proporcionou redução significativa da intensidade de caspa de até 53,2% após 17 a 20 aplicações, sendo o resultado positivo para 90,0% das participantes da pesquisa. - Análise sensorial por eficácia percebida: após 17 a 20 aplicações do xampu (composição do Exemplo 1), 90,0% dos participantes perceberam redução da descamação do couro cabeludo, redução das caspas aderidas (oleosas) no couro cabeludo e redução da recorrência de caspas entre uma lavagem e outra; 86,7% perceberam a redução da irritação do couro cabeludo causada pelas caspas e 83,3% perceberam redução da oleosidade do couro cabeludo.[43] According to the results obtained, it was possible to verify that: - Sensory analysis by clinical efficacy: the shampoo (Example 1) provided a significant reduction in the intensity of dandruff of up to 53.2% after 17 to 20 applications, with a positive result for 90.0% of survey participants. - Sensory analysis by perceived efficacy: after 17 to 20 applications of the shampoo (composition in Example 1), 90.0% of the participants noticed a reduction in scalp peeling, a reduction in adhered (oily) dandruff on the scalp and a reduction in the recurrence of dandruff between washings; 86.7% perceived a reduction in scalp irritation caused by dandruff and 83.3% perceived a reduction in scalp oiliness.
[44] Com relação à agradabilidade do xampu (Exemplo 1), 90,0% acharam a característica da espuma agradável, 83,3% acharam que os cabelos ficaram limpos e com sensação de frescor, 76,7% acharam que os cabelos ficaram brilhantes com aspecto saudável e deixou um perfume agradável nos cabelos, 60% acharam que o xampu (Exemplo 1) evitou o ressecamento dos fios deixando os cabelos hidratados e com toque macio e 90% disseram que comprariam o xampu (Exemplo 1).[44] Regarding the pleasantness of the shampoo (Example 1), 90.0% found the characteristic of the lather pleasant, 83.3% thought the hair was clean and with a feeling of freshness, 76.7% thought the hair remained shiny with a healthy appearance and left a pleasant perfume on the hair, 60% thought that the shampoo (Example 1) prevented the dryness of the threads, leaving the hair hydrated and with a soft touch and 90% said they would buy the shampoo (Example 1).
[45] Foi realizada também uma avaliação da eficácia de produtos anticaspas por análise de imagem, fundamentada na obtenção de fotografias digitais de alta resolução, sob condições técnicas controladas antes e após 17 a 20 aplicações do xampu.[45] An evaluation of the effectiveness of antidandruff products was also carried out by image analysis, based on obtaining high-resolution digital photographs, under controlled technical conditions, before and after 17 to 20 applications of the shampoo.
[46] A Tabela 1 revela os valores da Quantidade de Caspa obtidos na avaliação por análise de imagens: [46] Table 1 reveals the Dandruff Amount values obtained in the image analysis evaluation:
[47] De acordo com os resultados obtidos, foi possível constatarque o xampu proporcionou redução significativa da quantidade de caspas de até 77,6% após 17 a 20 aplicações e 96,7% das participantes da pesquisa apresentaram redução da quantidade de caspa após 17 a 20 aplicações da composição do Exemplo 1.[47] According to the results obtained, it was possible to verify that the shampoo provided a significant reduction in the amount of dandruff of up to 77.6% after 17 to 20 applications and 96.7% of the research participants showed a reduction in the amount of dandruff after 17 to 20 applications of the composition of Example 1.
[48] Os resultados apresentados revelam um efeito surpreendente da composição compreendendo o complexo seborregulador, sendo capaz de proporcionar diversos benefícios em conjunto para o controle da oleosidade capilar ou tratamento da caspa, gerando uma redução significativa na manifestação da caspa, alívio da coceira pela redução da irritação do couro cabeludo e redução da recorrência de caspas entre uma lavagem em outra, após poucas aplicações do produto.[48] The results presented reveal a surprising effect of the composition comprising the seborregulatory complex, being able to provide several benefits together for the control of capillary oil or dandruff treatment, generating a significant reduction in the manifestation of dandruff, relief from itching by reducing scalp irritation and reduction in the recurrence of dandruff between one wash after another, after a few applications of the product.
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