U.S. patent application number 12/200426 was filed with the patent office on 2009-03-05 for cosmetic use of bifidobacterium species lysate for the treatment of dryness.
This patent application is currently assigned to L'OREAL. Invention is credited to Lionel BRETON, Isabelle CASTIEL, Audrey GUENICHE.
Application Number | 20090060962 12/200426 |
Document ID | / |
Family ID | 39271155 |
Filed Date | 2009-03-05 |
United States Patent
Application |
20090060962 |
Kind Code |
A1 |
CASTIEL; Isabelle ; et
al. |
March 5, 2009 |
COSMETIC USE OF BIFIDOBACTERIUM SPECIES LYSATE FOR THE TREATMENT OF
DRYNESS
Abstract
Cosmetic use of an effective amount of a lysate of at least one
microorganism of the genus Bifidobacterium species and/or one of
its fractions in treating and/or preventing dryness and/or
associated disorders of a keratinous substance.
Inventors: |
CASTIEL; Isabelle; (Nice,
FR) ; BRETON; Lionel; (Versailles, FR) ;
GUENICHE; Audrey; (Rucil Malmaison, FR) |
Correspondence
Address: |
OLIFF & BERRIDGE, PLC
P.O. BOX 320850
ALEXANDRIA
VA
22320-4850
US
|
Assignee: |
L'OREAL
Paris
FR
|
Family ID: |
39271155 |
Appl. No.: |
12/200426 |
Filed: |
August 28, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60973541 |
Sep 19, 2007 |
|
|
|
Current U.S.
Class: |
424/401 ;
424/780 |
Current CPC
Class: |
A61K 8/99 20130101; A61P
17/00 20180101; A61Q 19/007 20130101; A61K 8/9728 20170801; A61P
17/16 20180101; A61P 43/00 20180101 |
Class at
Publication: |
424/401 ;
424/780 |
International
Class: |
A61K 35/74 20060101
A61K035/74; A61K 8/06 20060101 A61K008/06; A61K 9/107 20060101
A61K009/107; A61P 17/00 20060101 A61P017/00; A61Q 19/00 20060101
A61Q019/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 4, 2007 |
FR |
07 57348 |
Claims
1. A cosmetic method for treating and/or preventing dryness and/or
associated disorders of a keratinous substance comprising
administering to a subject an effective amount of a lysate of at
least one microorganism of the genus Bifidobacterium species and/or
one of its fractions.
2. The method according to claim 1, in which the said microorganism
is intended to prevent or treat dry skin.
3. The method according to claim 1, in which the said microorganism
is intended to prevent and/or reduce the wrinkles related to
cutaneous dryness.
4. The method according to claim 1, in which the said microorganism
is intended to improve the comfort of dry skin and a dry scalp.
5. The method according to claim 1, in which the said microorganism
is intended to combat the dull and/or lifeless appearance of the
skin as a consequence of it drying out.
6. The method according to claim 1, in which the said microorganism
is intended to prevent and/or treat drying of the skin as a
consequence of an application of a chemical product and/or the
carrying out of a peeling or of a shaving operation.
7. The method according to claim 1, in which the said microorganism
is intended to prevent or treat the expression of signs of weakness
of keratinous fibres.
8. The method according to claim 1, in which the microorganism of
the genus Bifidobacterium species is selected from the group
consisting of Bifidobacterium longum, Bifidobacterium bifidum,
Bifidobacterium breve, Bifidobacterium animalis, Bifidobacterium
lactis, Bifidobacterium infantis, Bifidobacterium adolescentis or
Bifidobacterium pseudocatenulatum and their mixtures.
9. The method according to claim 1, in which the microorganism of
the genus Bifidobacterium species is Bifidobacterium longum.
10. The method according to claim 1, in which the said lysate
comprises from 0.1 to 50% by weight, of active material(s).
11. The method according to claim 1, in which the said lysate is
administered by the topical route.
12. The method according to claim 1, in which the said lysate is
administered by the oral route.
13. A cosmetic method for treating and/or preventing a dry dandruff
state of the scalp comprising administering to a subject an
effective amount of a lysate of at least one microorganism of the
genus Bifidobacterium species and/or one of its fractions.
14. A method for treating and/or preventing dryness or associated
disorders of a keratinous substance comprising the preparation of a
composition comprising an effective amount of a lysate of at least
one microorganism of the genus Bifidobacterium species and/or one
of its fractions.
15. A method for treating and/or preventing a dry dandruff state of
the scalp comprising the preparation of a composition comprising an
effective amount of a lysate of at least one microorganism of the
genus Bifidobacterium species and/or one of its fractions.
16. A cosmetic and/or dermatological composition for preventing
and/or treating dry keratinous substances, comprising, in a
physiologically acceptable medium, at least an effective amount of
a lysate of at least one microorganism of the genus Bifidobacterium
species in combination with at least an effective amount of at
least one additional microorganism, and/or one of its fractions
and/or one of its metabolites, distinct from the said lysate.
17. The composition according to claim 16, in which the
microorganism of the genus Bifidobacterium species is selected from
the group consisting of Bifidobacterium longum, Bifidobacterium
bifidum, Bifidobacterium breve, Bifidobacterium animalis,
Bifidobacterium lactis, Bifidobacterium infantis, Bifidobacterium
adolescentis or Bifidobacterium pseudocatenulatum, and their
mixtures.
18. The composition according to claim 16, in which the said lysate
is present in a proportion of at least one 0.0001% by weight
(expressed as dry weight) with respect to the total weight of the
said composition.
19. The composition according to claim 16, in which the said
probiotic microorganism is selected from the group consisting of
the Ascomycetes, such as Saccharomyces, Yarrowia, Kluyveromyces,
Torulaspora, Schizosaccharomyces pombe, Debaromyces, Candida,
Pichia, Aspergillus and Penicillium, bacteria of the genus
Bifidobacterium, Bacteroides, Fusobacterium, Melissococcus,
Propionibacterium, Enterococcus, Lactococcus, Staphylococcus,
Peptostreptococcus, Bacillus, Pediococcus, Micrococcus,
Leuconostoc, Weissella, Aerococcus, Oenococcus, Lactobacillus, and
their mixtures.
20. The composition according to claim 16, in which the additional
microorganism results from the group of the lactic bacteria.
21. The composition according to claim 16, in which the additional
microorganism is chosen from the strains Lactobacillus johnsonii
(CNCM I-1225).
22. The composition according to claim 16, in which the probiotic
microorganism and/or one of its fractions and/or one of its
metabolites is present in a proportion of 0.1 to 10% by weight of
the said composition.
23. The composition according to claim 16, in which it is provided
in the form of aqueous, aqueous/alcoholic or oily solutions, of
dispersions of the type of solutions or dispersions of the lotion
or serum type, of emulsions of the liquid or semiliquid consistency
of the milk type, obtained by dispersion of a fatty phase in an
aqueous phase (O/W) or vice versa (W/O), or of suspensions or
emulsions with a soft, semisolid or solid consistency of the cream
type, of aqueous or anhydrous gels, or also of microemulsions, of
microcapsules, of microparticles or of vesicular dispersions of
anionic and/or nonionic type.
24. A cosmetic and/or dermatological composition, of use in
particular for preventing and/or treating dry keratinous
substances, comprising, in a physiologically acceptable medium, at
least an effective amount of a lysate of at least one microorganism
of the genus Bifidobacterium species in combination with at least
an effective amount of at least one moisturizing active
principle.
25. A cosmetic method for treating and/or preventing dryness and/or
associated disorders of a keratinous substance in a subject,
comprising at least one step of administration to the said subject
of at least an effective amount of at least one microorganism of
the genus Bifidobacterium species in the form of a lysate.
26. The method according to claim 25, in which the microorganism of
the genus Bifidobacterium species is selected from the group
consisting of Bifidobacterium longum, Bifidobacterium bifidum,
Bifidobacterium breve, Bifidobacterium animalis, Bifidobacterium
lactis, Bifidobacterium infantis, Bifidobacterium adolescentis or
Bifidobacterium pseudocatenulatum and their mixtures.
Description
[0001] This non provisional application claims the benefit of
French Application No. 07 57348 filed on Sep. 4, 2007 and U.S.
Provisional Application No. 60/973,541 filed on Sep. 19, 2007.
[0002] The present disclosure mainly concerns at providing a novel
active principle for preventing and/or treating dryness of
keratinous substances and in particular skin described as dry.
BACKGROUND
[0003] It is known that an increase in cutaneous dryness is often
observed with age; however, such cutaneous dryness states may also
occur in young subjects. This is because the cutaneous dryness
state is a physiological state which may be present in young
subjects without any pathological cause, at least apparent
pathological cause. The origin of this dryness may be
constitutional or acquired. Thus, many external factors can result
in drying of the skin or can aggravate the state of the skin which
is already dry. Mention may be made, among these factors, of
difficult climatic conditions, solar radiation, or exposure to
certain chemical or therapeutic agents.
[0004] Dry skin is often associated physiologically with a fall in
the level of cutaneous hydration and with a detrimental change in
the barrier function, measured by the imperceptible water loss. It
is in particular characterized sensorially by a feeling of skin
tightness and/or tension. For obvious reasons, these manifestations
are sources of discomfort, indeed even of pain.
SUMMARY
[0005] There thus remains a need to have available novel active
principles capable of exerting a beneficial cosmetic or therapeutic
effect on the epidermis or keratinous substances in general which
are described as dry. Within the meaning of the disclosure, the
term "epidermis" is intended to denote both the skin and the
scalp.
[0006] Unexpectedly, the Inventors have found that some probiotic
microorganisms can prove to be particularly effective in the
prevention and/or treatment of dry skin, with the proviso that they
are employed in the form of a lysate.
[0007] Consequently, according to a first aspect, a subject-matter
of the disclosure is the cosmetic use of an effective amount of a
lysate of at least one microorganism of the genus Bifidobacterium
species and/or one of its fractions for treating and/or preventing
dryness and/or associated disorders of a keratinous substance, in
particular dry epidermides, such as the skin or scalp.
[0008] According to another of its aspects, the present disclosure
concerns the use of an effective amount of a lysate of at least one
microorganism of the genus Bifidobacterium species and/or one of
its fractions in the preparation of a composition intended to treat
and/or prevent dryness and/or associated disorders of a keratinous
substance.
[0009] In particular, such a composition proves to be effective in
treating ichthyoses, psoriasis, hyperkeratoses, topical
dermatitides and dry dandruff states of the scalp.
[0010] The present disclosure relates, according to another of its
aspects, to the cosmetic use of an effective amount of a lysate of
at least one microorganism of the genus Bifidobacterium species
and/or one of its fractions in treating and/or preventing a dry
dandruff state of the scalp, and more particularly dry
dandruffs.
[0011] According to another of its aspect, the present disclosure
concerns the use of an effective amount of a lysate of at least one
microorganism of the genus Bifidobacterium species and/or one of
its fractions in the preparation of a composition intended to treat
and/or prevent a dry dandruff state of the scalp.
[0012] Within the meaning of the present disclosure, the term "to
prevent" means to reduce the risk of appearance of the phenomenon
concerned.
[0013] According to another of its aspects, a subject-matter of the
disclosure is a method, in particular a cosmetic method, for
treating and/or preventing dryness and/or associated disorders of a
keratinous substance, in particular dry epidermides, such as the
skin or scalp, in a subject, comprising at least one step of
administration to the said subject of at least an effective amount
of a lysate of at least one microorganism of the genus
Bifidobacterium species and/or one of its fractions.
[0014] According to another of its aspects, a subject-matter of the
present disclosure is a cosmetic and/or dermatological composition,
of use in particular for preventing and/or treating dry keratinous
substances, in particular dry epidermides, such as the skin or
scalp, comprising, in a physiologically acceptable carrier, at
least an effective amount of a lysate of at least one microorganism
of the genus Bifidobacterium species and/or one of its fractions,
in combination with an effective amount of at least one additional
microorganism, in particular a probiotic microorganism, distinct
from said lysate.
[0015] Within the meaning of the disclosure, the expression
"distinct from said lysate" means that it is possible to
distinguish, within the composition, either two different
microorganisms or two different forms of the same microorganism.
Thus, when the additional microorganism is of the genus
Bifidobacterium species and corresponds to the same species as that
representing the lysate required according to the disclosure, this
additional microorganism is then present in a form other than a
lysate.
[0016] According to another of its aspects, the present disclosure
concerns a cosmetic and/or dermatological composition, of use in
particular for preventing and/or treating dry keratinous
substances, in particular dry epidermides, such as the skin or
scalp, comprising, in a physiologically acceptable carrier, at
least an effective amount of a lysate of at least one microorganism
of the genus Bifidobacterium species and/or one of its fractions,
in combination with an effective amount of at least one
moisturizing active principle in particular as described below.
[0017] Urea and its derivatives are very particularly suitable as
such.
[0018] According to an alternative embodiment of the disclosure,
the lysate according to the disclosure can be administered by the
oral route.
[0019] According to another alternative embodiment of the
disclosure, the lysate according to the disclosure can be
administered by the topical route.
[0020] As specified below, the compositions comprising it are
formulated in order to be compatible with the method of
administration selected.
[0021] The term "effective amount" is understood to mean, within
the meaning of the present disclosure, an amount sufficient to
produce the expected effect.
DETAILED DESCRIPTION OF EMBODIMENTS
[0022] Dry Skin
[0023] As indicated above, dry skin is essentially expressed by a
feeling of tightness and/or tension. The skin is also rough to the
touch and appears covered with squamae. When the skin is slightly
dry, these squamae are profuse but not very visible to the naked
eye. They becomes less numerous but increasingly visible to the
naked eye when this disorder worsens.
[0024] In the scalp, the formation of such dry squamae or dandruff
is symptomatic of a dry dandruff state.
[0025] With respect to the scalp, the dry dandruff states are
chronic, frequent, recurring and socially disabling states. Stress
and the winter period reinforce these states in the majority of the
individuals. The integrity and homeostasis of the scalp are
regulated by an assembly of parameters including sebum secretion
and the intra-individual sensitivity.
[0026] Thus, during dandruff states of the scalp, the cutaneous
barrier, its integrity and its ecological flora are unbalanced.
[0027] The skin of the scalp is irritated, and pruriginous,
fragile, less hydrated and develops significant desquamation which
is reflected a dry dandruff state.
[0028] A dry dandruff state is different from a greasy dandruff
state.
[0029] The former is reflected in particular by the presence of
white or grey squamae, dry and of small size, whereas the latter is
characterized by greasy, large and yellow squamae. The origin of
this cutaneous dryness can be of constitutional or acquired
type.
[0030] In the case of constitutional dry skin, it is possible to
distinguish two categories: pathologic skin and nonpathologic
skin.
[0031] Pathologic constitutional dry skin is represented
essentially by atopic dermatitis and ichthyoses. It is virtually
independent of the external conditions.
[0032] Atopic dermatitis is described as associated with a
deficiency in the metabolism of the lipids of the stratum corneum
and in particular of the ceramides. This pathology presents itself
in the form of a more or less chronic xerosis affecting a large
expanse of the body, associated or not associated with inflammatory
and pruriginous eruptions by patches.
[0033] Atopic dermatitides are also described as chronic
inflammatory pathologies of the skin, often coexisting with other
atopic pathologies, such as rhinitis, conjunctivitides and allergic
asthma. In the majority of cases, atopic dermatitis is reflected by
dry skin associated with dysfunctionings of the epidermal barrier.
An increase in imperceptible water loss is nearly always
encountered.
[0034] Thus, the barrier function of the skin is detrimentally
affected not only on the parts affected by eczema but also with
regard to noninflammatory dry skin. This detrimental change
accordingly facilitates the penetration of various substances from
the environment into the skin.
[0035] What is more, colonisation of the skin by Staphylococcus
aureus strains is generally correlated with atopic dermatitis.
[0036] Ichthyoses are pathologies characterized by a genetic
deficiency which affects the keratinization process at various
stages. They are manifested by significant desquamation by
patches.
[0037] The pathologic constitutional dry skin concerned according
to the disclosure is more particularly dry skin or dry scalp of
noninflammatory origin.
[0038] In the case of nonpathologic constitutional dry skin, the
severity of the state of dryness can, for its part, depend on
external factors. Senile skin (characterized by a general reduction
in cutaneous metabolism with age), fragile skin (very sensitive to
external factors and often accompanied by erythema and rosacea) and
xerosis vulgaris (of probable genetic origin and manifesting itself
predominantly on the face, limbs and back of the hands) come within
this skin category.
[0039] In the case of acquired dry skin, the involvement of
external parameters, such as exposure to chemical agents, to
difficult climatic conditions, to solar radiation or alternatively
certain therapeutic treatments (retinoids, for example), is
determining. Under these external influences, the epidermis can
then become temporarily and locally dry. This can concern any type
of epidermis.
[0040] Thus, cutaneous dryness can also be induced by an exogenous
stress of chemical origin, for example of peeling type, or also of
mechanical origin (rubbing, shaving).
[0041] It should be remembered that a peeling operation consists
essentially in applying a chemical substance to the skin with the
aim of bringing about limited and controlled destruction of the
epidermis and of the surface layers of the dermis in order to
improve certain disorders of the appearance of the skin.
[0042] At the same time as the peelings which may be described as
chemical from the viewpoint of the chemical products which they
employ, a technology involving the use of ablative and nonablative
laser beams has also been developed.
[0043] The first ablative laser beams, produced with pulsed or
scanned CO.sub.2 lasers, have the immediate effect of vaporizing
(or ablating) the epidermis and often the upper part of the dermis.
A strip of the underlying dermis is generally also the site of
thermal injury with denaturation and contraction of the collagen.
During the healing phase, reepithelization occurs starting from the
hair follicles and other adnexa in addition to an upper dermal
strip ("remodelling of the collagen").
[0044] The latest generation of lasers uses a system of conversion
of the laser beam into a multitude of beams spaced out from one
another in order to produce, on the skin, impacts spaced out from
one another, thus maintaining, between the affected areas, areas of
healthy skin not detrimentally changed.
[0045] For obvious reasons, peeling thus has an action which,
although controlled, remains irritating with regard to the surface
of the epidermis and liable to induce cutaneous dryness.
[0046] The compositions, methods and uses according to the
disclosure thus prove to be very particularly effective: [0047] in
treating states of cutaneous dryness, squamous states and in
particular dry dandruff states, [0048] in treating dry skin, [0049]
in treating itching and/or tightness associated with dry skin,
[0050] in treating cutaneous disorders related to a deficiency in
excretion and/or secretion of sebum, [0051] in physiologically
restoring a suitable state of hydration to the stratum corneum,
[0052] in treating hyposeborrhoeic dry skin, [0053] in stimulating
sebogenesis, [0054] in preventing and/or reducing wrinkles related
to cutaneous dryness, [0055] in improving the comfort of dry skin
and a dry scalp, and in particular dry dandruff states, [0056] in
combating the dull and/or lifeless appearance of the skin as a
consequence of it drying out, [0057] in treating dry keratinous
fibres, [0058] in treating skin which has been subjected to a
drying exogenous stress induced by a chemical product, such as a
peeling composition, for example, or induced by peeling by
radiation or also induced mechanically, in particular by rubbing,
for example in shaving.
[0059] When the keratinous substances are human or animal
keratinous fibres, such as the hair, body hairs and/or eyelashes,
the active principle under consideration according to the
disclosure proves to be particularly advantageous in preventing
and/or treating the expression of signs of weakness, such as, for
example, the dryness which is generally reflected by a brittle
aspect of the fibre. It thus makes it possible to confer a glossy
appearance on the keratinous fibres, in particular on human hair
and on the coats of animals.
[0060] According to one embodiment of the disclosure, a lysate of
microorganisms in accordance with the disclosure is not employed as
agent for inhibiting adhesion of the pathogenic flora of the
skin.
[0061] Microorganisms
[0062] As specified above, the microorganisms of the genus
Bifidobacterium species used as active principles according to the
disclosure are employed in the form of a lysate.
[0063] A lysate commonly denotes a material obtained on conclusion
of the destruction or dissolution of biological cells by a "cell
lysis" phenomenon, thus resulting in the release of the
intracellular biological constituents naturally present in the
cells of the microorganism under consideration.
[0064] Within the meaning of the present disclosure, the term
"lysate" is used without distinction to denote the whole of the
lysate obtained by lysis of the microorganism concerned or only a
fraction of the latter.
[0065] The lysate employed is thus formed all or in part of the
intracellular biological constituents and of the wall and cell
membrane constituents.
[0066] More specifically, it comprises the cell cytoplasmic
fraction including enzymes, such as lactic acid dehydrogenase,
phosphatases, phosphoketolases and transaldolases. By way of
illustration, the constituents of the cell walls are in particular
peptidoglycan, murein or mucopeptide and teichoic acid and the
constituents of the cell membranes are compounds of
glycerophospholipid.
[0067] This cell lysis can be accomplished by various technologies,
such as, for example, osmotic shock, heat shock, with ultrasound,
or also under mechanical stress of centrifuging type, for
example.
[0068] More particularly, this lysate can be obtained according to
technology described in U.S. Pat. No. 4,464,362 and in particular
according to the following protocol.
[0069] The microorganism of Bifidobacterium species type under
consideration is cultured anaerobically in an appropriate culture
medium, for example according to the conditions described in the
documents U.S. Pat. No. 4,464,362 and EP 43 128. When the
stationary phase of the development is reached, the culture medium
can be inactivated by pasteurization, for example at a temperature
of 60 to 65.degree. C. for 30 min. The microorganisms are then
collected by a conventional separation technique, for example
membrane filtration or centrifuging, and resuspended in a sterile
physiological NaCl solution.
[0070] The lysate can be obtained by disintegrating such a medium
using ultrasound in order to release therefrom the cytoplasmic
fractions, the cell wall fragments and the products resulting from
the metabolism. Then all the components in their natural
distribution are subsequently stabilized in a weakly acidic aqueous
solution.
[0071] A concentration of the order of 0.1 to 50% by weight, in
particular of 1 to 20% by weight and especially of approximately 5%
by weight of active material(s), with respect to the total weight
of the lysate, is thus generally obtained.
[0072] The lysate can be employed in different forms, in the form
of a solution or in a pulverulent form.
[0073] The microorganism belonging to the genus Bifidobacterium
species is more particularly chosen from the species:
Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium
breve, Bifidobacterium animalis, Bifidobacterium lactis,
Bifidobacterium infantis, Bifidobacterium adolescentis or
Bifidobacterium pseudocatenulatum and their mixtures.
[0074] The species Bifidobacterium longum is very particularly
suitable for the disclosure.
[0075] Within the meaning of the disclosure, the term "fraction"
more particularly denotes a fragment of the said microorganism
which is effective in the treatment of dry epidermides by analogy
with the said whole microorganism.
[0076] The product sold under the name Repair Complex CLR.RTM. by
K. RICHTER GmbH, which is formed of an inactivated lysate of the
species Bifidobacterium longum, comes within the scope of the
disclosure.
[0077] The active principle forming the lysate belonging to the
genus Bifidobacterium species can be formulated in a proportion of
at least 0.0001% by weight (expressed as dry weight), in particular
in a proportion of 0.001 to 20% by weight and more particularly in
a proportion of 0.001 to 2% by weight, with respect to the total
weight of the carrier or of the composition comprising it.
[0078] In the specific case where the microorganism(s) is (are)
formulated in compositions to be administered by the oral route,
the concentration of microorganism(s), in particular probiotic
microorganism(s), can be adjusted so as to correspond to doses
(expressed as microorganism equivalent) varying from
5.times.10.sup.2 to 10.sup.13 ufc/d and in particular from 10.sup.5
to 10.sup.11 ufc/d.
[0079] According to an alternative form of the disclosure, this
lysate is employed in combination with another microorganism.
[0080] Thus, the compositions according to the disclosure can in
addition advantageously comprise at least one additional
microorganism, in particular of probiotic type, and/or one of its
fractions and/or one of its metabolites.
[0081] Within the meaning of the present disclosure, the term
"probiotic microorganism" is understood to mean a living
microorganism which, when it is consumed in an appropriate amount,
has a positive effect on the health of its host, "Joint FAO/WHO
Expert Consultation on Evaluation of Health and Nutritional
Properties of Probiotic in Food Including Powder Milk with Live
Lactic Acid Bacteria, 6 Oct. 2001", and which can in particular
improve the intestinal microbial balance.
[0082] These microorganisms which are suitable for the disclosure
can be chosen in particular from the Ascomycetes, such as
Saccharomyces, Yarrowia, Kluyveromyces, Torulaspora,
Schizosaccharomyces pombe, Debaromyces, Candida, Pichia,
Aspergillus and Penicillium, bacteria of the genus Bacteroides,
Fusobacterium, Melissococcus, Propionibacterium, Enterococcus,
Lactococcus, Staphylococcus, Peptostreptococcus, Bacillus,
Pediococcus, Micrococcus, Leuconostoc, Weissella, Aerococcus,
Oenococcus and Lactobacillus, and their mixtures.
[0083] Mention may in particular be made, as Ascomycetes which are
particularly suitable for the present disclosure, of Yarrowia
lipolitica and Kluyveromyces lactis, as well as Saccharomyces
cerevisiae, Torulaspora, Schizosaccharamyces pombe, Candida and
Pichia.
[0084] Specific examples of probiotic microorganisms are
Lactobacillus acidophilus, Lactobacillus alimentarius,
Lactobacillus curvatus, Lactobacillus delbruckii subsp. Lactis,
Lactobacillus gasseri, Lactobacillus johnsonii, Lactobacillus
reuteri, Lactobacillus paracasei, Lactobacillus rhamnosus
(Lactobacillus GG), Lactobacillus sake, Lactococcus lactis,
Streptococcus thermophilus, Staphylococccus carnosus, and
Staphylococcus xylosus and their mixtures.
[0085] More particularly, they are probiotic microorganisms
resulting from the group of the lactic bacteria, such as, in
particular, the Lactobacillus species. Mention may more
particularly be made, by way of illustration of these lactic
bacteria, of Lactobacillus johnsonii, Lactobacillus paracasei,
Lactobacillus reuteri, Lactobacillus rhamnosus and their
mixtures.
[0086] As specified above, the additional microorganism may or may
not be the same species as that forming the lysate. However, when
it is the same species, it is then present in a form other than a
lysate, for example in a living form.
[0087] The species which are very particularly suitable are
Lactobacillus johnsonii, in particular the strain deposited
according to the Treaty of Budapest with the Institut Pasteur (28
rue du Docteur Roux, F-75024 Paris cedex 15) under the following
designation CNCM I-1225.
[0088] Generally, the compositions for topical application
according to the disclosure generally comprise from 0.0001 to 30%,
in particular from 0.001 to 15% and more particularly from 0.1 to
10% of one or more additional microorganisms, in particular
probiotic microorganisms.
[0089] This or these microorganism(s) can be included in the
compositions according to the disclosure in a living, semi-active
or inactivated, or dead form.
[0090] It/they can also be included in the form of fractions of
cell components. The microorganism(s) or fraction(s) can also be
introduced in the form of a powder, of a liquid, of a culture
supernatant or one of its fractions, diluted or undiluted, or also
concentrated or nonconcentrated.
[0091] In the case where the microorganisms are formulated in a
composition in a living form, the amount of living microorganisms
can vary from 10.sup.3 to 10.sup.15 ufc/g, in particular from
10.sup.5 to 10.sup.15 ufc/g and more particularly from 10.sup.7 to
10.sup.12 ufc/g of microorganisms per gram of composition.
[0092] The compositions according to the disclosure can be provided
in all the formulation forms normally available for the method of
administration selected.
[0093] The carrier can be of various natures, depending on the type
of composition under consideration.
[0094] As regards more particularly the compositions intended for
administration by the external topical route, that is to say at the
surface of a keratinous substance, such as the skin, they can be
aqueous, aqueous/alcoholic or oily solutions, dispersions of the
type of solutions or dispersions of the lotion or serum type,
emulsions of a liquid or semi-liquid consistency of the milk type,
obtained by dispersion of a fatty phase in an aqueous phase (O/W)
or vice versa (W/O), or of suspensions or emulsions of the cream
type, aqueous or anhydrous gels, microemulsions, microcapsules,
microparticles or vesicular dispersions of ionic and/or nonionic
type.
[0095] These compositions are prepared according to the usual
methods.
[0096] These compositions can in particular constitute cleansing,
protecting, treating or care creams for the face, for the hands,
for the feet, for the major anatomical folds or for the body (for
example, day creams, night creams, make-up-removing creams, cream
foundations or sun creams), make-up products, such as liquid
foundations, make-up-removing milks, protective or care body milks,
aftersun milks, lotions, gels or foams for caring for the skin,
such as cleansing or disinfecting lotions, sun lotions, artificial
tanning lotions, bath compositions, deodorant compositions
comprising a bactericidal agent, aftershave gels or lotions,
depilatory creams or compositions for combating insect stings and
bites.
[0097] The compositions according to the disclosure can also
consist of solid preparations constituting cleansing soaps or
bars.
[0098] They can also be used for the scalp in the form of
solutions, creams, gels, emulsions or foams or also in the form of
aerosol compositions also comprising a pressurized propellant.
[0099] When the composition of the disclosure is an emulsion, the
proportion of the fatty phase can range from 5 to 80% by weight and
preferably from 5 to 50% by weight, with respect to the total
weight of the composition. The oils, the emulsifiers and the
coemulsifiers used in the composition in the form of an emulsion
are chosen from those conventionally used in the cosmetic and/or
dermatological field. The emulsifier and the coemulsifier can be
present in the composition in a proportion ranging from 0.3 to 30%
by weight and preferably from 0.5 to 20% by weight, with respect to
the total weight of the composition.
[0100] When the composition of the disclosure is an oily solution
or gel, the fatty phase can represent more than 90% of the total
weight of the composition.
[0101] In a known way, the formulation forms intended for topical
administration can also comprise adjuvants which are normal in the
cosmetic, pharmaceutical and/or dermatological field, such as
hydrophilic or lipophilic gelling agents, hydrophilic or lipophilic
active principles, preservatives, antioxidants, solvents,
fragrances, fillers, screening agents, bactericides, odour
absorbers and colouring materials. The amounts of these various
adjuvants are those conventionally used in the field under
consideration, for example from 0.01 to 20% of the total weight of
the composition. These adjuvants, depending on their nature, can be
introduced into the fatty phase and/or into the aqueous phase.
[0102] Mention may be made, as fatty substances which can be used
in the disclosure, of mineral oils, such as, for example,
hydrogenated polyisobutene and liquid petrolatum, vegetable oils,
such as, for example, a liquid fraction of shea butter, sunflower
oil and apricot kernel oil, animal oils, such as, for example,
perhydrosqualene, synthetic oils, in particular Purcellin oil,
isopropyl myristate and ethylhexyl palmitate, unsaturated fatty
acids and fluorinated oils, such as, for example,
perfluoropolyethers. Use may also be made of fatty alcohols, fatty
acids, such as, for example, stearic acid, and such as, for
example, waxes, in particular paraffin wax, carnauba wax and
beeswax. Use may also be made of silicone compounds, such as
silicone oils, for example cyclomethicones and dimethicones,
silicone waxes, silicone resins and silicone gums.
[0103] Mention may be made, as emulsifiers which can be used in the
disclosure, for example, of glyceryl stearate, polysorbate 60, the
cetearyl alcohol/oxyethylenated cetearyl alcohol comprising 33 mol
of ethylene oxide mixture sold under the name Sinnowax AO.TM. by
Henkel, the PEG-6/PEG-32/Glycol Stearate mixture sold under the
name Tefose.RTM. 63 by Gattefosse, PPG-3 myristyl ether, silicone
emulsifiers, such as cetyl dimethicone copolyol, and sorbitan mono-
or tristearate, PEG-40 stearate or oxyethylenated (20 EO) sorbitan
monostearate.
[0104] Mention may be made, as solvents which can be used in the
disclosure, of lower alcohols, in particular ethanol and
isopropanol, or propylene glycol.
[0105] The composition of the disclosure can also advantageously
comprise a thermal and/or mineral water chosen in particular from
water from Vittel, water from the Vichy basin and water from La
Roche Posay.
[0106] Mention may be made, as hydrophilic gelling agents, of
carboxyl polymers, such as carbomer, acrylic copolymers, such as
acrylate/alkylacrylate copolymers, polyacrylamides, in particular
the mixture of polyacrylamide, C13-14 Isoparaffin and Laureth-7
sold under the name Sepigel 305.TM. by SEPPIC, polysaccharides,
such as cellulose derivatives, for example hydroxyalkylcelluloses,
in particular hydroxypropylcellulose and hydroxyethylcellulose,
natural gums, such as guar, locust bean and xanthan gums, and
clays.
[0107] Mention may be made, as lipophilic gelling agents, of
modified clays, such as bentones, metal salts of fatty acids, such
as aluminium stearates, and hydrophobic silica, or also
ethylcellulose and polyethylene.
[0108] In the case of the use of a combination in accordance with
the disclosure by the oral route, use of an ingestible carrier is
favoured.
[0109] Milk, yogurt, cheese, fermented milks, milk-based fermented
products, ice creams, products based on fermented cereals,
milk-based powders, formulas for children and infants, foodstuffs
of confectionery, chocolate or cereal type, foods for animals, in
particular domestic animals, tablets, including compressed tablets,
hard gelatin capsules, oral supplements in a dry form and oral
supplements in the liquid form are suitable in particular as
dietary or pharmaceutical carriers.
[0110] Numerous embodiments of oral compositions and in particular
of food supplements are possible for ingestion. They are formulated
by standard processes for producing tablets, including sugar-coated
tablets, capsules, including hard gelatin capsules, gels or
emulsions. In particular, the active principle(s) according to the
disclosure can be incorporated in any other form of food supplement
or enriched food, for example food bars, or compacted or
uncompacted powders. The powders can be diluted with water or in
fizzy drinks, dairy products or soya derivatives or can be
incorporated in food bars.
[0111] According to a specific embodiment, the additional
microorganisms under consideration according to the disclosure can
be formulated in compositions in an encapsulated form, so as to
significantly improve their lifetime. In such a case, the presence
of a capsule can in particular slow down or prevent the
decomposition of the microorganism in the gastrointestinal
tract.
[0112] Of course, the topical or oral compositions or the
combinations according to the disclosure can additionally comprise
several other active principles.
[0113] Mention may be made, as active principles conventionally
employed, of vitamins B3, B5, B6, B8, C, E or PP, niacin,
carotenoids, polyphenols and minerals, such as zinc, calcium,
magnesium, and the like.
[0114] In particular, use may be made of an antioxidant complex
comprising vitamins C and E and at least one carotenoid, in
particular a carotenoid chosen from .beta.-carotene, lycopene,
astaxanthin, zeaxanthin and lutein, flavonoids, such as catechins,
hesperidin, proanthocyanidins and anthocyanins.
[0115] At least one prebiotic or one mixture of prebiotics may also
be involved. More particularly, these prebiotics can be chosen from
oligosaccharides, produced from glucose, galactose, xylose,
maltose, sucrose, lactose, starch, xylan, hemicellulose, inulin,
gums of acacia type, for example, or one of their mixtures. More
particularly, the oligosaccharide comprises at least one
fructooligosaccharide. More particularly, this prebiotic can
comprise a mixture of fructooligosaccharide and of inulin.
[0116] In the topical formulation forms, use may more particularly
be made, as hydrophilic active principles, of proteins or protein
hydrolysates, amino acids, polyols, in particular C.sub.2 to
C.sub.10 polyols, such as glycerol, sorbitol, butylene glycol and
polyethylene glycol, urea, allantoin, sugars and sugar derivatives,
water-soluble vitamins, starch, or bacterial or plant extracts,
such as those of aloe vera.
[0117] As regards the lipophilic active principles, use may be made
of retinol (vitamin A) and its derivatives, tocopherol (vitamin E)
and its derivatives, ceramides, essential oils and nonsaponifiable
materials (tocotrienol, sesamin, .gamma.-oryzanol, phytosterols,
squalenes, waxes or terpenes).
[0118] According to one embodiment, a composition of the disclosure
is devoid of vitamin A.
[0119] According to an alternative form of the disclosure, the
lysate in accordance with the disclosure can be employed in a
topical composition with an agent which is active with regard to
the epidermides, in particular dry epidermides.
[0120] Mention may in particular be made, by way of illustration
and without implied limitation of such active principles, of
moisturizing active principles.
[0121] The term "moisturizing active principle" is understood to
mean: [0122] either a compound which influences the barrier
function, for the purpose of maintaining the hydration of the
stratum corneum, or an occlusive compound. Mention may be made of
ceramides, sphingoid-based compounds, lecithins,
glycosphingolipids, phospholipids, cholesterol and its derivatives,
phytosterols (stigmasterol, .beta.-sitosterol or campesterol),
essential fatty acids, 1-2-diacylglycerol, 4-chromanone,
pentacyclic triterpenes, petrolatum and lanolin; [0123] or a
compound which directly increases the water content of the stratum
corneum, such as urea and its derivatives, trehalose and its
derivatives, hyaluronic acid and its derivatives, glycerol,
pentanediol, pidolates, serine, xylitol, lactic acid and sodium
lactate, glyceryl polyacrylate, ectoine and its derivatives,
chitosan, oligo- and polysaccharides, cyclic carbonates,
N-lauroylpyrrolidonecarboxylic acid and
N-.alpha.-benzoyl-L-arginine; [0124] or a compound which activates
the sebaceous glands, such as steroidal derivatives (including
DHEA) and vitamin D and its derivatives.
[0125] These compounds can represent from 0.001% to 30% and
preferably from 0.01 to 20% of the total weight of the composition
according to the disclosure.
[0126] Mention may more particularly be made, by way of
illustration of the urea derivatives, of the (hydroxyalkyl)urea
derivatives, in particular derivatives described in the document FR
2 877 222.
[0127] Consideration may also be given, as active principles
capable of being more particularly combined with the lysate in an
oral formulation formula, to all the ingredients commonly used
and/or authorized.
[0128] Mention may be made, by way of illustration, of vitamins,
minerals, essential lipids, trace elements, polyphenols,
flavonoids, phyto-oestrogens, antioxidants, such as lipoic acid and
coenzyme Q10, carotenoids, prebiotics, proteins and amino acids,
mono- and polysaccharides, amino sugars, phytosterols and
triterpene alcohols of plant origin.
[0129] They are in particular vitamins A, C, D, E, PP and of the
group B. The choice has preferably been made, among carotenoids, of
.beta.-carotene, lycopene, lutein, zeazanthin and astaxanthin. The
minerals and trace elements particularly employed are zinc,
calcium, magnesium, copper, iron, iodine, manganese, selenium or
chromium(III). The selection is also in particular made, among
polyphenols, of grape, tea, olive, cocoa, coffee, potato,
blueberry, elder, strawberry, cranberry and onion polyphenols. The
selection is preferably made, among phyto-oestrogens, of
isoflavones in the free or glycosylated form, such as genistein,
daidzein or glycitein, or lignans, in particular those of flax and
Schisandra chinensis. Amino acids or the peptides and the proteins
comprising them, such as taurine, threonine, cysteine, tryptophan
or methionine. The lipids preferably belong to the group of the
oils comprising mono- and polyunsaturated fatty acids, such as
oleic, linoleic, .alpha.-linolenic, .gamma.-linolenic or
stearidonic acids, long-chain fish .omega.-3 fatty acids, such as
EPA and DHA, or conjugated fatty acids resulting from plant or
animals, such as CLAs (Conjugated Linoleic Acid).
[0130] The cosmetic treatment method of the disclosure can be
employed in particular by administering the cosmetic and/or
dermatological compositions or the combinations as defined above
according to the usual technique for the use of these compositions.
For example: applications of creams, gels, serums, lotions,
make-up-removing milks or aftersun compositions to the keratinous
substance, such as dry skin or hair, or application of a hair
lotion to wet hair or of shampoos as regards the topical
application.
[0131] The cosmetic method according to the disclosure can thus be
employed by topical administration, for example daily, of the
lysate under consideration according to the disclosure.
[0132] The method according to the disclosure can comprise a single
administration. According to another embodiment, the administration
is repeated, for example 2 to 3 times daily over a day or more and
generally over a prolonged period of time of at least 4 weeks,
indeed even 4 to 15 weeks, with, if appropriate, one or more
periods of interruption.
[0133] In the description and in the following examples, unless
otherwise indicated, the percentages are percentages by weight and
the ranges of values worded in the form "between . . . and . . . "
include the lower and upper limits specified. The ingredients are
mixed, before they are formed, in the order and under conditions
easily determined by a person skilled in the art.
[0134] The following examples are presented by way of illustration
and without implied limitation of the field of the disclosure.
Example 1
TABLE-US-00001 [0135] Milk for the care of dry skin of the face %
by weight Magnesium chloride 3.00 Calcium ascorbate 3.00
Bifidobacterium longum 10.00** lysate CLR (Repair Complex CLR
.RTM.)* Glyceryl stearate 1.00 Cetearyl alcohol/oxyethylenated
cetearyl alcohol 3.00 comprising 30 mol of EO (Sinnowax AO .RTM.,
sold by Henkel) Cetyl alcohol 1.00 Dimethicone (DC 200 Fluid .RTM.
sold by Dow Corning) 1.00 Liquid petrolatum 6.00 Isopropyl
myristate (Estol IMP 1514 .RTM., sold by Uniqema) 3.00 Antioxidant
0.05 Glycerol 20.00 Preservative 0.30 Water q.s. for 100 *Repair
Complex CLR .RTM., sold by K. Richter GmbH and corresponding to a
formulation comprising 5% by weight of active principles **amount
expressed as total product
Example 2
TABLE-US-00002 [0136] Milk for the care of dry skin of the face %
by weight Magnesium ascorbate 3.00 Blackcurrant seed oil 4.00
Borage oil 4.00 Inactivated Lactobacillus johnsonii powder 5.00
Bifidobacterium longum lysate CLR 10.00** (Repair Complex CLR
.RTM.)* Glyceryl stearate 1.00 Cetearyl alcohol/oxyethylenated
cetearyl alcohol 3.00 comprising 3 mol of EO (Sinnowax AO .RTM.,
sold by Henkel) Cetyl alcohol 1.00 Dimethicone (DC 200 Fluid .RTM.,
sold by Dow Corning) 1.00 Liquid petrolatum 6.00 Isopropyl
myristate (Estol IPM 1514 .RTM., sold by Uniqema) 3.00 Glycerol
20.00 Preservative 0.30 Water q.s. for 100 *Repair Complex CLR
.RTM., sold by K. Richter GmbH and corresponding to a formulation
comprising 5% by weight of active principles **amount expressed as
total product
Example 3
TABLE-US-00003 [0137] Lotion for the scalp % by weight
Bifidobacterium longum lysate CLR 5.00** (Repair Complex CLR
.RTM.)* Antioxidant 0.05 Isopropanol 40.0 Preservative 0.30 Water
q.s for 100 *Repair Complex CLR .RTM. sold by K. Richter GmbH and
corresponding to a formulation comprising 5% by weight of active
principles **amount expressed as total product
Example 4
TABLE-US-00004 [0138] Milk for the care of the scalp % by weight
Bifidobacterium longum (lysate CLR) 5.00** (Repair Complex CLR
.RTM.)* Glyceryl stearate 1.00 Cetearyl alcohol/oxyethylenated
cetearyl alcohol 3.00 comprising 30 mol of EO (Sinnowax AO .RTM.,
sold by Henkel) Cetyl alcohol 1.00 Dimethicone (DC 200 Fluid .RTM.
sold by Dow Corning) 1.00 Liquid petrolatum 6.00 Isopropyl
myristate (Estol IMP 1514 .RTM., sold by Uniqema) 3.00 Antioxidant
0.05 Preservative 0.30 Water q.s. for 100 *Repair Complex CLR .RTM.
sold by K. Richter GmbH and corresponding to a formulation
comprising 5% by weight of active principles **amount expressed as
total product
Example 5
TABLE-US-00005 [0139] Gel for the care of the scalp % by weight
Bifidobacterium longum (lysate CLR) 5.00** (Repair Complex CLR
.RTM.)* Hydroxypropylcellulose (Klucel H .RTM., sold by Hercules)
1.00 Vitamin E 2.50 Antioxidant 0.05 Isopropanol 40.00 Preservative
0.30 Water q.s. for 100 *Repair Complex CLR .RTM. sold by K.
Richter GmbH and corresponding to a formulation comprising 5% by
weight of active principles **amount expressed as total product
Example 6
TABLE-US-00006 [0140] Cream for the care of the scalp % by weight
Arachidyl behenyl alcohol/arachidyl glucoside 3.0 Isohexadecane 7.0
Bifidobacterium longum (lysate CLR) 5.00** (Repair Complex CLR
.RTM.)* Glycerol 2.0 Vitreoscilla filiformis extract 3.0 BHT 0.05
Methyl POB 0.1 Propyl POB 0.05 Water q.s. for 100 *Repair Complex
CLR .RTM. sold by K. Richter GmbH and corresponding to a
formulation comprising 5% by weight of active principles **amount
expressed as total product
Example 7
TABLE-US-00007 [0141] Gel for the care of the hair % by weight
Bifidobacterium longum (lysate CLR) 5.00** (Repair Complex CLR
.RTM.)* Copper citrate 2.00 Vitreoscilla filiformis extract 3.00
Antioxidant 0.05 Vitamin C 2.50 Antioxidant 0.05 Isopropanol 40.00
Preservative 0.30 Water q.s. for 100 *Repair Complex CLR .RTM. sold
by K. Richter GmbH and corresponding to a formulation comprising 5%
by weight of active principles **amount expressed as total
product
Example 8
TABLE-US-00008 [0142] Lotion for the face % by weight
Bifidobacterium longum lysate (Repair Complex CLR .RTM.)* 5.00**
Antiinflammatory 0.05 Antioxidant 0.05 Isopropanol 40.0
Preservative 0.30 Water q.s. for 100 *Repair Complex CLR .RTM. sold
by K. Richter GmbH and corresponding to a formulation comprising 5%
by weight of active principles **amount expressed as total
product
Example 9
TABLE-US-00009 [0143] Gel for the care of the face % by weight
Bifidobacterium longum lysate (Repair Complex CLR .RTM.)* 5.00**
Hydroxypropylcellulose (Klucel H .RTM., sold by Hercules) 1.00
Vitamin E 2.50 Antioxidant 0.05 Isopropanol 40.00 Preservative 0.30
Water q.s. for 100 *Repair Complex CLR .RTM. sold by K. Richter
GmbH and corresponding to a formulation comprising 5% by weight of
active principles **amount expressed as total product
Example 10
TABLE-US-00010 [0144] Cream for the care of the face % by weight
Arachidyl behenyl alcohol/arachidyl glucoside 3.0 Isohexadecane 7.0
Bifidobacterium longum lysate (Repair Complex CLR .RTM.)* 5.00**
Glycerol 2.0 Vitreoscilla filiformis extract 3.0 BHT 0.05 Methyl
POB 0.1 Propyl POB 0.05 Water q.s. for 100 *Repair Complex CLR
.RTM. sold by K. Richter GmbH and corresponding to a formulation
comprising 5% by weight of active principles **amount expressed as
total product
Example 11
TABLE-US-00011 [0145] Gel for the care of the face % by weight
Vitreoscilla filiformis extract 3.00 Bifidobacterium longum lysate
(Repair Complex CLR .RTM.)* 5.00** Antioxidant 0.05 Vitamin C 2.50
Antioxidant 0.05 Isopropanol 40.00 Preservative 0.30 Water q.s. for
100 *Repair Complex CLR .RTM. sold by K. Richter GmbH and
corresponding to a formulation comprising 5% by weight of active
principles **amount expressed as total product
Example 12
Evaluation of the Dryness of Subjects Treated with a
Bifidobacterium Lysate
[0146] The product tested is a Bifidobacterium longum lysate in
disintegrated (with ultrasound) suspension in a weakly acidic
aqueous medium, sold under the name Repair Complex CLR.RTM..
[0147] The active principle was tested alone in a randomized double
blind study.
[0148] Sixty-six women exhibiting dry skin were divided into two
groups, placebo (n=33, group A), Repair Complex CLR.RTM. (n=33
group B). The treatments were applied topically for 58 days, the
active principle being formulated at 10% of the test formulation.
This carrier formulation is an Arlacel/myrj.RTM. oil/demineralized
water emulsion comprising 5% Parleam, 15% cyclopentasiloxane, 3%
glycerol and 2% petrolatum.
[0149] In the placebo formulation, the absence of Repair Complex
CLR.RTM. is compensated for with water.
[0150] The subjects were evaluated at D1, D29, D43 and D57. On each
visit, evaluations of the dryness of the legs were carried out by
the dermatologist and by self-evaluation by the subjects according
to the forms specified below.
[0151] The investigating dermatologist evaluated on each visit the
cutaneous dryness of the area studied (the external face of the
right leg) according to a squama from 0 to 3 with regard to the
following criteria: 0=skin not dry, 1=slight dryness (slight
roughness), 2=moderate dryness (moderate roughness, a few squamas),
3=severe dryness (significant roughness and desquamation).
[0152] Furthermore, the investigating dermatologist, on each visit,
asked the subject for a self-evaluation of the state of cutaneous
dryness of her legs according to the following squama from 0 to 5:
0=not at all; 1=very slightly; 2=slightly; 3=moderately;
4=strongly; 5=very strongly.
[0153] At the same time, the change in various cutaneous markers
was studied by proteomics.
[0154] A sample is withdrawn from the external face of the leg at
times D1, D29, D43 and D57 by varnish stripping in order to
withdraw only a portion of the stratum corneum, i.e. at most 4 to 5
layers of stratum corneum.
[0155] A 41 .mu.m filter, type NY41 Millipore, nylon cloth
(5.times.5 cm) is applied to a predefined area of the left leg. A
transparent varnish with reference 614254/T.D., comprising:
nitrocellulose 6.86 g; isopropanol 2.94 g; hypoallergenic alkyl
resin 7.35 g; tributyl acetylcitrate 7.7 g; ethyl acetate 75.15 g;
is then spread using a brush (15 mm) and then left to dry for 15
min. The nylon cloth is subsequently recovered using tweezers, the
varnish strip being torn off with a sharp movement.
[0156] The varnish strips are stored flat at -20.degree. C. in
plastic bags.
[0157] These withdrawn samples of skin (stratum corneum varnish
strips) were subsequently analysed by proteomics in order to
evaluate the expression of various proteins according to the method
described by Zieske (J. Exp. Bot., 2006, 547:1501) and Wiesse et
al., (Proteomics, 2007, 7:340).
[0158] Results
[0159] a) By Clinical Scoring
[0160] The forms of the score of cutaneous dryness, expressed as
percentage, per visit and treatment are represented in Table 1
below. The groups are comparable at day 1 (p=0.8677).
[0161] An improvement over time is observed in both groups, which
improvement is more marked for the group being treated with the
topical formulation comprising 10% of Repair Complex CLR.RTM. and
very particularly at D29.
TABLE-US-00012 TABLE 1 Clinical Legs 0 1 2 3 Total A Time D1
Participants 0 0 21 11 32 % over time .0% .0% 65.6% 34.4% 100.0%
D15 Participants 7 8 15 2 32 % over time 21.9% 25.0% 46.9% 6.3%
100.0% D29 Participants 4 18 7 1 30 % over time 13.3% 60.0% 23.3%
3.3% 100.0% D43 Participants 8 15 3 3 29 % over time 27.6% 51.7%
10.3% 10.3% 100.0% D57 Participants 13 10 4 1 28 % over time 46.4%
35.7% 14.3% 3.6% 100.0% Total Participants 32 51 50 18 151 % over
time 21.2% 33.8% 33.1% 11.9% 100.0% B Time D1 Participants 0 0 21
10 31 % over time .0% .0% 67.7% 32.3% 100.0% D15 Participants 5 16
9 0 30 % over time 16.7% 53.3% 30.0% .0% 100.0% DJ29 Participants 8
19 3 0 30 % over time 26.7% 63.3% 10.0% .0% 100.0% D43 Participants
3 24 2 1 30 % over time 10.0% 80.0% 6.7% 3.3% 100.0% D57
Participants 11 15 4 0 30 % over time 36.7% 50.0% 13.3% .0% 100.0%
Total Participants 27 74 39 11 151 % over time 17.9% 49.0% 25.8%
7.3% 100.0%
[0162] The reduction in the clinical score for dryness over time
appears to be very significant (Chi-Square test, p<0.0001).
Thus, a significant difference is observed between the groups at
D29 (one-sided Chi-square test; p=0.0612) in favour of the
treatment with the topical formulation comprising 10% of Repair
Complex CLR.RTM..
[0163] b) By Self-Evaluation
[0164] The forms of the score for self-evaluated cutaneous dryness,
expressed as percentage, per visit and treatment are represented in
Table 2 below. The groups are comparable at D1 (p=0.3945).
[0165] An improvement over time is observed in both groups, which
improvement proves to be more marked for the group treated with the
topical formulation comprising 10% of Repair Complex CLR.RTM.,
particularly at D29, in a way comparable to what had been observed
for the clinical score.
TABLE-US-00013 TABLE 2 Legs rando 0 1 2 3 4 5 Total A Time D1
Participants 0 0 2 9 15 6 32 % over time .0% .0% 6.3% 28.1% 46.9%
18.8% 100.0% D15 Participants 2 11 6 11 2 0 32 % over time 6.3%
3.4% 18.8% 34.4% 6.3% .0% 100.0% D29 Participants 4 6 9 11 0 0 30 %
over time 13.3% 20.0% 30.0% 36.7% .0% .0% 100.0% D43 Participants 5
9 9 5 1 0 29 % over time 17.2% 31.0% 31.0% 17.2% 3.4% .0% 100.0%
D57 Participants 6 7 9 5 1 0 28 % over time 21.4% 25.0% 32.1% 17.9%
3.6% .0% 100.0% Total Participants 17 33 35 41 19 6 151 % over time
11.3% 21.9% 23.2% 27.2% 12.6% 4.0% 100.0% B Time D1 Participants 0
0 5 10 9 7 31 % over time .0% .0% 16.1% 32.3% 29.0% 22.6% 100.0%
D15 Participants 6 5 10 6 3 0 30 % over time 20.0% 16.7% 33.3%
20.0% 10.0% .0% 100.0% D29 Participants 8 9 7 5 1 0 30 % over time
26.7% 30.0% 23.3% 16.7% 3.3% .0% 100.0% D43 Participants 6 13 8 3 0
0 30 % over time 20.0% 43.3% 26.7% 10.0% .0% .0% 100.0% D57
Participants 8 14 5 3 0 0 30 % over time 26.7% 46.7% 16.7% 10.0%
.0% .0% 100.0% Total Participants 28 41 35 27 13 7 151 % over time
18.5% 27.2% 23.2% 17.9% 8.6% 4.6% 100.0%
[0166] The groups were compared on the different visits. A
significant difference is observed between the groups at D29
(one-sided Chi-square test; p=0.0561) in favour of the group
treated with the topical formulation comprising 10% of Repair
Complex CLR.RTM..
[0167] c) Analysis by Proteomics
[0168] The results of the analysis by proteomics showed that the
Bifidobacterium longum lysate stimulates the expression of various
proteins which defend the epidermis from microorganisms such as the
RNase 7, the dermcidin, the prolactin inducible protein (PiP), the
proteins S100 A8 and A9, the histone protein of certain proteases
involved in the phenomenon of desquamation (KLK7, KLK5, Cathepsin
L2), while other proteins reflecting the metabolic immatunity of
the cutaneous barrier see the decrease of their expression
(Bleomycin hydrolase, Enolase 1, TP1, GAPDH).
[0169] The defense properties of the skin against dryness are
therefore strengthened.
CONCLUSION
[0170] For the dryness of the legs (both by the clinical study and
the self-evaluations), a significant reduction is observed at D29
and, overall, after 2 months, a tendency towards reduction is
observed for the subjects who have been treated with the topical
formulation comprising 10% of Repair Complex CLR.RTM..
[0171] Although the present disclosure herein has been described
with reference to particular embodiments, it is to be understood
that these embodiments are merely illustrative of the principles
and applications of the present disclosure. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
disclosure as defined by the appended claims.
* * * * *