Hair loss abstract
A hair lotion with improved properties in its hair protecting action
and prevention of hair loss, and the reduction of external effects
of androgenic alopecia and resulting hair loss, that comprises as
an active ingredient a mixture consisting of: i) hop extract (Humulus
lupulus), ii) rosemary extract (Rosmarinus officinalis L.), iii)
Swertia extract (Swertia japonica) and iv) silanodiol salicylate;
the remaining ingredients consisting of a cosmetically and pharmaceutically
acceptable medium, in general an alcohol or hydroalcohol medium
that can contain other auxiliary ingredients, such as vitamins,
colorants, fragrances and similar substances.
Hair loss claims
What is claimed is:
1. A hair lotion comprising a mixture of active ingredients, including
(i) hop extract (Humulus lupulus), (ii) rosemary extract (Rosmarinus
officinalis L.), (iii) swertia extract (Swertia japonica) and (iv)
silanodiol salicylate, in a cosmetically acceptable medium, said
active ingredients being present in the hair lotion in respective
amounts effective for prevention or treatment of hair loss or promotion
of hair growth in a user.
2. The hair lotion according to claim 1, wherein the active ingredients
are present in respective amounts that satisfy the following relationship:
hop extract>rosemary extract>swertia extract>silanodiol
3. The hair lotion according to claim 1, wherein the active ingredients
are present in the lotion in respective amounts as follows: hop
extract . . . 55-65% weight/weight rosemary extract . . . 25-35%
weight/weight Swertia japonica extract . . . 7-10% weight/weight
Silanodiol salicylate . . . 1-2% weight/weight.
4. The hair lotion according to claim 3, wherein the active ingredients
(i), (ii), (iii), and (iv) comprise 2 to 6% weight/weight of all
ingredients in the hair lotion.
5. The hair lotion according to claim 4, wherein the medium comprises
an alcohol or hydroalcohol.
6. The hair lotion according to claim 5, wherein the medium comprises
7. The hair lotion according to claim 5, wherein the medium further
comprises an auxiliary ingredient or ingredients selected from the
group consisting of vitamins, colorants and fragrances.
8. The hair lotion according to claim 7, wherein the medium comprises
9. A method for prevention or treatment of hair loss in a user
comprising administering to the user the hair lotion of claim 1
in an amount effective to prevent or treat hair loss.
10. A method for prevention or treatment of hair loss in a user
comprising administering to the user the hair lotion of claim 4
in an amount effective to prevent or treat hair loss.
11. A method for promotion of hair growth in a user comprising
administering to the user the hair lotion of claim 1 in an amount
effective to promote hair growth.
12. A method for promotion of hair growth in a user comprising
administering to the user the hair lotion of claim 4 in an amount
effective to promote hair growth.
Hair loss description
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
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
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
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 and nutrients supply to the base
of the follicle, revitalising the hair cells, which translates into
a stimulation of hair growth.
Silanodiol salicylate is a biologically active silicon compound
which is described in the International Patent Publication WO 96/10574
as follows: 2,2-dimethyl-4-oxobenzo-1,3-dioxa-2-silane Stabilizer:
salicyclic acid ##STR1##
The silicon along with carbon is the most abundant chemical element
in nature. In trace quantities it plays an important role in biological
systems and is present in the epidermis and the cuticle of hair
where it acts to increase the chemical resistance of keratin by
participating in the reticulation of the collagen fibres and accordingly
in restructuring the hair contributing mainly to an increase in
the resistance of the hair shaft. In addition to the action of the
silicon in biological systems in general, several documents have
been published which show its importance in the regulation of the
physiological cycle of the hair and as a dermal papilla cytostimulant.
The three main properties of silicon, of great usefulness in the
hair treatments are: Restructuring/hydrating effects, because it
binds to proteins and other hydrating substances allowing the scalp
to retain the necessary degree of humidity and to avoid dehydration.
Cytostimulant of the dermal and hair follicle cells. Anti free-radical
element which reorganises the cell membranes, making them more resistant
to attack by these free radicals and therefore to ageing.
The problem of supplying silicon to biological systems consists
in finding a way that can be assimilated by the organism in opposition
to elemental silicon or silicones. A silicon compound that satisfies
this requirement is silanodiol salicylate which, together with the
three vegetal extracts mentioned hereinabove, has been seen to be
particularly suitable as a hair-protection and growth-promotion
The applicant firm understands that the interaction of silanodiol
salicylate (which, of the four active ingredients, is the one used
in least amount) with different molecular species contained in the
extracts of the three plants mentioned hereinabove that form the
rest of the active ingredients, provokes a tonic and protective
effect against the causes of androgenic alopecia when applied to
the scalp. This leads to a reduction in hair loss, and in the case
that the hair follicles have not become completely atrophied, a
re-growth of new hair may occur. These effects are demonstrated
in the trial carried out with 40 volunteers. This trial is described
in more detail later in the Examples.
A brief examination of the various attempts in the art to find
an efficient cosmetic composition to control hair loss and stimulating
growth is now made.
SU 488559 (UKRBYTKHIM FIRM) which relates to a hair conditioner
that prevents hair loss and the formation of dandruff, which contains
extracts with carbonate of the warmwood plant, glycerine, emulsifier
and water. With regards with the present invention it should be
pointed out that this patent only mentions one (hop extract) of
the four active ingredients which the lotion object of the invention
JP 40022598 (SHIGEKURA), whose title is: "Gentian Extracts"
describes a process for obtaining extracts from the gentian plant
from which it is said that they have a tonic action and stimulate
hair growth, and that they are also effective for treating hepatic
ailments and cancerous growths. Furthermore, properties of cardiac
stimulation are attributed to them, and cosmetic uses for the skin.
Among the wide variety of additional ingredients that can be incorporated
into these extracts the extract of the Japanese Swertia plant is
JP 40018281 (OGIHARA) relates to a process for obtaining an ester
of acetic acid and an ingredient extracted from gentian plants,
such as Swertia chinensis, Swertia tosaenis, etc (which the express
exclusion of Swertia japonica). It is said of the acetate obtained
that it is used as an agent for accelerating hair growth or as a
skin cosmetic. As the japonica variety is expressly excluded, it
can be concluded that this Japanese patent is not related to the
object of the present application. As can be appreciated the active
ingredient of this patent has a mixed character between a net vegetal
component and synthetic compound component.
CA 672965 (HAGIWARA) relates to a nutritive or restorative hair
composition that comprises at least one of the bitter components
of the Swertia japonica Makino plant and a non-toxic diluent. In
addition to the hair nutritive or restorative properties which are
mentioned in the document, anti-seborrheic and anti-pruritic properties
are also attributed to it.
FR 2129804 (SLATCHO) is directed at "Detaining hair loss using
a cream or lotion that contains camphor and lard". Among other
ingredients found in the cream or lotion rosemary extract can be
FR 1545601 (PEREIRA-BORGES-MARQUES M) relates to an anti-dandruff
lotion which contains extracts of rosemary and eucalyptus leaves,
bone marrow and bay salt. In addition to only containing one of
the active ingredients of the lotion of the present invention, it
is not expressly directed at controlling hair loss and enhancing
hair growth, but indirectly through controlling dandruff.
JP 05051308 (FUKUDA HIDECO) describes the treatment of hair with
a solution whose active ingredients consist exclusively of components
of different herbs among which rosemary and Swertia japonica can
JP 09175950 (DAIICHI SEIYAKU CO. LTD.) specifically describes preparations
for stimulating hair growth that contain stabilised carpronium chloride
and plant extracts, among which rosemary and Swertia japonica are
JP 09183718 (KOSEI CO LTD) relates to cosmetic compositions for
external use, whose main active ingredients are phytic acid and/or
salts thereof. As optional ingredients extracts of rosemary and
Swertia japonica are mentioned.
EP-0797984 (belonging to the firm SISHEIDO COMPANY LIMITED and
claiming priority from the Japanese application 97105058) describes
a composition, among whose ingredients extracts of rosemary and
Swertia are found, and although it is specifically directed to controlling
ageing of the skin, it also has a utility as a hair tonic as it
acts on the zone which surrounds the hairs.
JP 10059829 (NOEVIR CO, LTD) has as an object hair tonics containing
nutrients encapsulated in lipids. Rosemary and hop extracts are
among the various mentioned ingredients.
JP 07196456 (SUNSTAR KK) has as an object the hair preparations
that contains copolymers of vinylpyrrolidone and plant extracts,
among which those of rosemary and hops are mentioned then having
the same relation with the lotion of the present invention as that
of the Japanese patent cited in the previous paragraph.
CH 682631 (V. FORGACS, K. PACZOLAY, G. PINTZ and JP TATAR) describes
compositions that promote hair growth that contain herbal components
such as nettle, pansy and chickweed as the main components, citing
hop and rosemary extracts as other optional ingredients.
SU 1247011 (AEROSOL SCIENTIFIC-INDUSTRIAL ENTERPRISES) describes,
just as the two previous patents, hair compositions among whose
ingredients hop and rosemary extracts are mentioned.
U.S. Pat. No. 4,933,177 (L'OREAL) describes cosmetic compositions
for hair and skin treatment in the form of dust particles, the relation
to the lotion of the present invention being that rosemary is found
among the ingredients of the composition.
JP 09241131 (NENDO KAGAKU KENKYUSHO KK) describes agents which
promote hair growth, among whose ingredients hops and Swertia japonica
U.S. Pat. No. 5,656,264 (SANSYO SEIYAKU CO, LTD) relates to a method
for promoting hair growth by application of a composition whose
main ingredients are of synthetic nature, among which compounds
of diphenyl-urea, pyrimidine derivatives, imidazole compounds, benzoylaminourea
compounds and compounds of aminopyrrolo [2,3-d]-pyrimidine can be
found. In said patent it is indicated that the previous compounds
can be used with other ingredients among which rosemary is cited.
U.S. Pat. No. 5,053,222 (SHISEDO COMPANY LTD) describes a cosmetic
composition for hair care whose main active ingredients are a diester
of phosphoric acid with ascorbic acid and tocopherol. Among other
optional ingredients extracts of diverse plants are mentioned, among
which rosemary is cited.
EP 0872228 (KAO CORPORATION) relates to cosmetic methods that employ
compositions whose active ingredients are exclusively of vegetal
origin, among which rosemary and Swertia extracts are cited.
JP 10152426 (KANEBO LTD) has as an object skin conditioning compositions
that contain urea as an essential ingredient, and diverse products
derived from plants among which those from rosemary, hops and Swertia
JP 07277939 (DOWA MINING CO) relates to topical preparations, of
anti-ageing cosmetic use, which contain active oxygen, anti-oxidants,
and other biologically active substances, among which extracts of
rosemary, hops an Swertia japonica are cited.
U.S. Pat. No. 4,919,.846 (SHISEIDO COMPANY LTD) protects a detergent
composition which contains a quaternary ammonium cationic surfactant
and a carboxylate anionic surfactant. Said composition, which has
a utility as a shampoo, and not as an anti-hair loss or hair-growth
promoter lotion, can have other non-essential ingredients such as
extracts of Swertia japonica, rosemary and hops.
From the point of view of synthetic compounds with anti-hair loss
and/or hair growth promoter activity, MINOXIDIL (whose chemical
name is 6-(1-piperidinyl)-2,4-pyrimidinediamine 3-oxide, U.S. Pat.
No. 3,644,364) is well known. It was initially used in therapy al
hypotensor. When hypertensive patients noticed an unexpected hair
growth, advantage was taken of this side effect, and for a certain
period it was used as a hair regenerator such that in Spain the
"Vademecun Internacional" of 1997 lists the pharmaceutical
product "LACOVIN", consisting of a 2% hydroalcohol solution
containing propylene glycol. However, because even when applied
topically it acted as a hypotensive agent it has been banned by
the European Union as a cosmetic product due to the danger of its
use by hypotensive patients. Similarly, its pharmaceutical use as
an oral hypotensive agent has been rejected, due both to its secondary
effects and because it has been surpassed by new families of hypotensive
With regards patent application WO /10574 (PCT/FR 95/01267), in
which the preparation of a family of biologically active silicon
compounds is described, among which silanodiol salicylate is found,
it should be noted that only in Example 5 of said patent an anti-hair
loss lotion is described. However, said lotion has the peculiarities
of: a) using silyl-pantenol as specific compound (different to methyl
salicylate); b) using a quantity (4%) very much higher than that
of the silicon compound used in the present invention (<0.1%);
and c) being destined to control seborrheic alopecia.
Reviewing the prior art it is deduced that the hair lotion of the
invention is not anticipated by the compositions that have tried
to solve the problem of alopecia. In addition to its excellent properties
the lotion of the invention have the advantage of using the synthetic
silicon ingredient in minimal quantities, less than 0.1%, by weight,
which for practical purposes allows it to be classed as an ecological
From the quantitative point of view, the hair lotion of the invention
has the following composition:
Active Ingredient (three extracts+Si compound) . . . 2 to 6% w/w
Rest of ingredients . . . 98 to 94% w/w.
The proportion of the four components of the active ingredient
is such that it complies with the ratio:
where: L--% of hop extract R--% of rosemary extract Sw--% of Swertia
extract Ssi--% of silanodiol salicylate
with the preferred values, relative to the total weight of active
components, being the following: L . . . 55-65% weight/weight R
. . . 25-35% weight/weight Sw . . . 7-10% weight/weight Ssi . .
. 1-2% weight/weight.
For the lotion object of the invention to produce results, an intensive
programmed of daily application of an ampoule containing a single-dose
of 6 ml for at least 6 weeks, is necessary.
It is very desirable that the intensive treatment is followed by
a maintenance programme of 3 6-ml ampoules every other day for 2
In cases of severe alopecia, the intensive treatment should be
extended for a further 2 months, and then the maintenance programme
followed in identical way.
It is highly advisable that before applying the hair lotion object
of the invention, the hair is washed 2 or 3 times a week with a
suitable shampoo of a pH of approximately 5.5. Then, after drying
the hair with a towel the content of the ampoule is applied by gentle
massage to favour absorption and to facilitate irrigation of the
The invention is illustrated by the following Examples which are
only intended for illustrative purposes and are not limiting.
Using usual methods in cosmetics a batch of 10 kg of a lotion of
the invention is prepared with the following composition:
Amount in Component grams % W/W Denaturised 2700 27.00 alcohol
Hydrogenated 150 1.50 oxyethylenated castor oil Fragrance 175 1.75
Deionised 6640 66.40 water Swertia 25 0.25 extract Silanodiol 7
0.07 salicylate Hop extract 210 2.10 Rosemary 85 0.85 extract Panthenol
8 0.08 Total 10000 100.00
Following the same process as in Example 1, another formulation
was prepared in accordance with the invention with the following
composition per 100 g. Rosemary extract . . . 1.1 g Hop extract
. . . 1.8 g Swertia extract . . . 0.25 g Silanodiol salicylate .
. . 0.04 g Ethyl alcohol . . . 32 g Water, s.q.ad . . . 100 g
Evaluation of the Properties of the Lotion of the Invention
To evaluate the in vitro efficacy of the hair lotion object of
the invention, a method has been developed for determining the inhibitory
action exerted by said lotion on the activity of the 5-alpha-reductase
(type I) enzyme responsible for the formation of dihyrdotestosterone
(DHT) en the follicle cells.
It has been demonstrated that the hop and rosemary extracts used
act as efficient inhibitors of the enzyme, reducing its activity
between 50% and 80% of that observed in absence of the inhibitor.
To evaluate the efficacy of the hair lotion object of the invention
against hair loss an assay has been carried out in which the efficacy
of the product of the invention denominated Con. 628 and a comparative
product denominated Con. 749 were studied. 40 volunteers (20 men
and 20 women) who were suffering either from androgenic alopecia
or telogen elluvious took part in the study. Each individual randomly
received one of the two products and was shown how to apply the
product to the scalp in accordance with the defined method twice
a day for 6 months.
Before the start of the study (time t0) and after 2, 4 and 6 months
of treatment dermatological ascertainments and instrumental evaluations
were carried out. Photricograms of 9 defined area of the scalp were
carried out at the beginning and at the end of the treatment.
The results obtained with the two products are shown in he following
Con. 749 (without organic extracts or organosilicic compound Con.
623 (Lotion of the invention) An improvement was appreciated, which
was not A statistically significant improvement in the statistically
significant to traction of the resistance of the anagenic hair to
traction was resistance of the anagenic hair appreciated after four
months of treatment and at the end of the treatment (P < 0.05).
A progressive resolution of the clinical signs A progressive resolution
of the two clinical signs associated with hair loss were appreciated
(seborrhea associated with hair loss (seborrhea and dandruff) and
dandruff). The reduction in the values of the were appreciated.
The reduction of the values of clinical rating related to the two
signs was not the clinical rating related to dandruff is statistically
significant at any time during the statistically significant after
four and six study months of treatment (p < 0.05). A non-statistically
significant reduction in the A statistically significant reduction
in the amount of hair loss per wash at the end of the amount of
hair loss per wash at the end of the treatment was observed treatment
was observed (p < 0.05) An increase in the micro-circulation
of the scalp was A statistically significant increase in the micro-
observed at the end of the treatment, line of circulation of scalp
at the end of the treatment significant separation (p = 0.05) was
appreciated (p < 0.05) A statistically significant reduction
in the A statistically significant reduction in the sebometric values
after 4 months and after 6 months sebometric values after four months
(p = 0.01) and of treatment was observed (p < 0.05). after six
months (p < 0.051) was observed. A 10.8% statistically significant
increase in new A 22.4% statistically significant increase in new
hair growth at the end of the trial (p < 0.05) hair growth at
the end of the trial (p < 0.05) expressed as average of hair
density per unit surface expressed as average of hair density per
unit area was observed surface area was observed. A statistically
significant increase in rapid hair A statistically significant increase
in rapid hair growth (anagenic) and a statistically significant
growth (anagenic) and a statistically significant reduction in slow
hair growth (telegeny) was observed reduction in slow hair growth
(telegeny) was at the end of the treatment (p < 0.05) observed
at the end of the treatment (p < 0.05) An 8% increase in the
A/T ratio (anagen/telegen), An 20% increase in the A/T ratio (anagen/telegen),
statistically representative, was appreciated at the statistically
representative, was appreciated at end of the treatment. the end
of the treatment
Subjective Determination After Treatment
At the end of the treatment each patient from a group of 20 was
asked to give his or her opinion (personal impression) on the efficacy
of the product of the invention against hair loss on the following
four-point scale. 0--No efficacy 1--Little efficacy 2--Moderate
efficacy 3--High efficacy
The results are shown in the following table
0 1 2 3 Cod. 749 -- 5 (25%) 14 (70%) 1 (5%) Cod. 628 -- 3 (15%)
13 (65%) 4 (20%)
No signs related with local intolerance were observed during treatment.
Some patients reported a reduction in seborrhea and an increase
in the dryness of the scalp for the trial products.