Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions
Reexamination Certificate
2000-01-20
2002-09-10
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
C424S401000, C514S063000, C514S880000
Reexamination Certificate
active
06447762
ABSTRACT:
The present invention relates to a hair lotion with properties that prevent hair loss and stimulate hair growth. The peculiarity of the hair lotion object of the invention lies in the synergic effect arising from the interaction of its four active ingredients, consisting of three plant extracts and a synthetic organosilicic compound.
Alopecia, colloquially known as baldness, strictly speaking cannot be considered as a disease but rather a biological dysfunction which produces a feeling of discomfort and/or uneasiness in the affected individual, which may even lead to serious psychological disorders. The most common form is androgenic alopecia, which, among the mammals, affects chimpanzees, orangutans, and other primates, as well as men.
It is estimated that the number of hairs in man varies on average between 100,000 and 150,000, with a loss of 50 to 100 hairs a day being considered normal. It is understood that to avoid baldness it is important to maintain the average number of hairs, that is, to maintain the hair cycle, whereby the hair is formed, grows and falls out before being replaced by another new hair that appears in the same follicle.
The most common of the various classes of alopecia is androgenic alopecia which, as indicated by its name, is induced by androgenic stimulation of the hair follicles and is influenced by genetic and age factors. In this type of baldness testosterone, the best-known male hormone produced by the genital organs, plays an important role, although it is not the only substance involved. However, 50% of circulating testosterone is produced by peripheral tissues. It is known that in the hair follicle the enzyme 5-alpha-reductase (also called testosterone-reductase) converts the testosterone into dihydrotestosterone (DHT), which has a more powerful action than testesterone, which accumulates in the follicular cell membrane, reducing its functionality and accordingly retarding the hair growth.
It is a known fact that the upper part of the scalp responds to androgens in a different way to the rest of the body. On the other hand, it is paradoxical that the production of androgens from puberty onwards favours hair growth in areas of the body that develop terminal hair (beard, chest, armpits, calves) and at the same time reduce the growth of hair at the vertex (upper part of the scalp). The cause of this unexplainable paradox probably lies in the genetic difference in hormonal-type response determined by different receptor tissue specificity according to the zone implicated.
In women, the presence of high estrogen amounts (female hormones) inhibits the effect of androgens, which counteracts the effects of the androgens on the base of the hair bulb. As a result, the arrival of the menopause with subsequent reduction in female hormone levels, means that the circulating androgens have the upper hand, and so can set off an alopecic symptomatology similar to that seen in males. Thus, an hormonal approach explains why alopecic phenomena appear just after puberty in males while in females they do not manifest themselves until after the reproductive capacity of the individual has extinguished and biological maturity reached.
The first histological change that occurs is the appearance of degenerative foci in the sheath of the follicle connective tissue with the resulting basophilic perivascular change. The follicle progressively contracts, leaving behind a sclerotic and hyaline filament of connective tissue. Nevertheless, even in scalp areas where the follicles have shrunk, and therefore produce a very small vellus, there are still a reduced number of static terminal follicles, whose growth would be possible to try to stimulate. Androgenic alopecia is a very widespread condition, particularly in its least severe forms.
Other factors that facilitate the complex phenomenon of hair loss, besides hormones are:
ageing of the follicle cells by external aggressions and lack of care
deficiency in nutrition of the hair by progressive reduction in the micro-circulation in the scalp
weak growth of the hair cells which reproduce more slowly and with lower numbers.
Other aetiologies of alopecia, which are mentioned for informative purposes only, as they do not fall within those treated by the hair lotion object of the invention are, among others: a) temporal alopecia caused by the administration of drugs of different types, the most well known being those derived from the administration of anti-cancer products; b) alopecia of nutritional or metabolic origin; c) alopecia caused by alterations to the central nervous system; d) alopecia areata consisting on the sudden disappearance of hear from one or several areas of the scalp, due to an alteration in the immunological system whereby the follicle is attacked by the lymphocytes and the anagen stage is suddenly interrupted.
For many years now, and in order to satisfy an ever growing demand in today's society in which personal image is a very important factor for many people, the cosmetic industry has been investigating hair compositions that reduce, and ideally eliminate, the effect of alopecia, and more specifically, induce or facilitate hair growth.
The applicant firm, after a long and complex investigation has found a new hair lotion, whose essential characteristic is the specific nature of its four active ingredients, three of which are of vegetal origin and the fourth is of synthetic origin, more specifically an organosilicic compound. The three ingredients of vegetal origin are:
i) hop extract (
Humulus lupulus
),
ii) rosemary extract (
Rosmarinus officinalis
L.),
iii) Swertia extract (
Swertia japonica
) and the fourth compound is
iv) silanodiol salicilate.
The rest of the ingredients of the formulation are formed by a cosmetically acceptable medium, in general an alcohol or hydroalcohol medium which can contain other auxiliary ingredients, such as vitamins, colorants, fragrances, etc.
Rosemary (
Rosmarinus officinalis
) is a shrub-like plant of the Lamiaceae family, which reaches up to a metre in height with narrow leaves with a whitish underside. Its flowers are liliaceous or white-coloured. The extract used in the lotion of the invention, which contains a wide variety of molecular species, is an hydroalcohol (50% alcohol) extract of the leaves of the plant with a 7-10% w/w concentration of dry material 7-10% w/w. There are numerous studies which have shown that rosemary extract acts in two basic biochemical ways in the complex phenomenon that underlie alopecia:
It protects the cell membranes that help to neutralise the action of free radicals generated by numerous uncontrolled oxidation reactions that take place in the tissues.
It inhibits the formation of the dihydrotestosterone (DHT) directly implicated in alopecia, as explained above.
The hops (
Humulus lupulus
) is a plant of the cannabinacea family. The main industrial use of this plant is in the manufacture of beer. The hops oil mainly contains terpenes and humulene [(E,E,E)-2,6,6,9-tetramethyl-1,4,8-cycloundecatriene]. An hydroalcohol lotion is used in the lotion of the present invention which act as:
an inhibitor of the activity of the 5-alpha-reductase (type I) enzyme responsible for the formation of DHT, which is the main hormone responsible for hair loss in androgenic alopecia,
an activator of keratinocyte proliferation,
an anti-oxidant inhibitor of free radicals, slightly less effective than the rosemary extract.
Of the wide variety of families of the Swertia plant, in the hair lotion of the present invention
Swertia japonica
is used, concretely a glycol extract with a swertiamarin content not lower than 3% (w/w). This plant is widely accepted in Japan, both for internal and external use, for the treatment of a wide variety of diseases. In studies carried out by S. Utsunomiya, T. Nishiura and Y. Hagihara in the Department of Dermatology of the Tokushima University (Japan) it has been shown that thanks to the direct stimulation of the hair follicles and activation of blood circulation to the hair roots, the extract favours the oxygen an
Colomer Group Spain, S.L.
Ladas & Parry
Page Thurman K.
Sheikh Humera N.
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