U.S. patent application number 14/919048 was filed with the patent office on 2017-02-16 for method of improving skin appearance.
The applicant listed for this patent is The Procter & Gamble Company. Invention is credited to Colin John CLARKE, Chanda Janese DAVIS, Raniele Janine JAGO, Paul Jonathan MATTS, Nicole Annette MOSBY, Elizabeth Anne WILDER.
Application Number | 20170042311 14/919048 |
Document ID | / |
Family ID | 54366540 |
Filed Date | 2017-02-16 |
United States Patent
Application |
20170042311 |
Kind Code |
A1 |
WILDER; Elizabeth Anne ; et
al. |
February 16, 2017 |
Method of Improving Skin Appearance
Abstract
A skin care kit is provided. The skin care kit has a cosmetic
composition having an effective amount of a skin active agent and
one or more barrier patches. The barrier patch has a backing layer
having a first surface and a pressure sensitive adhesive in contact
with the first surface. The barrier patch also has an adhesive
release force of about 50 gms to about 400 gms; a flexibility of
about 8 grams to about 40 grams; and a WVTR of about 1 g/m.sup.2/24
h to about 500 g/m.sup.2/24 h. The kit also includes a display
package with a display surface.
Inventors: |
WILDER; Elizabeth Anne;
(West Chester, OH) ; MATTS; Paul Jonathan;
(Addlestone, GB) ; MOSBY; Nicole Annette;
(Cincinnati, OH) ; CLARKE; Colin John; (Ashford,
GB) ; DAVIS; Chanda Janese; (Cincinnati, OH) ;
JAGO; Raniele Janine; (Cincinnati, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The Procter & Gamble Company |
Cincinnati |
OH |
US |
|
|
Family ID: |
54366540 |
Appl. No.: |
14/919048 |
Filed: |
October 21, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62066765 |
Oct 21, 2014 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 8/678 20130101;
A61K 8/36 20130101; B65D 5/68 20130101; A61K 2800/10 20130101; A45D
40/24 20130101; B65D 77/006 20130101; A61K 8/64 20130101; A61M
35/10 20190501; A61K 8/671 20130101; B65D 5/4802 20130101; A61K
8/673 20130101; A61Q 19/00 20130101; B65D 77/30 20130101; A45D
33/38 20130101; A61K 8/361 20130101; A45D 2200/1036 20130101; A61F
13/00063 20130101; A61K 8/0208 20130101; A61K 8/38 20130101; B65D
5/66 20130101; A45D 37/00 20130101; A45D 40/18 20130101; A45D
44/002 20130101; A61K 2800/88 20130101; B65D 2203/00 20130101; A61K
2800/87 20130101; A45D 2200/053 20130101 |
International
Class: |
A45D 44/00 20060101
A45D044/00; A61K 8/49 20060101 A61K008/49; A61K 8/34 20060101
A61K008/34; B65D 77/30 20060101 B65D077/30; A61K 8/36 20060101
A61K008/36; A61K 8/38 20060101 A61K008/38; A45D 40/18 20060101
A45D040/18; B65D 77/00 20060101 B65D077/00; A61K 8/67 20060101
A61K008/67; A61K 8/64 20060101 A61K008/64 |
Claims
1. A skin care kit comprising: a cosmetic composition comprising an
effective amount of a skin active agent; a barrier patch comprising
a backing layer having a first surface and a pressure sensitive
adhesive in contact with the first surface; the barrier patch
comprising an adhesive release force of from about 50 gms to about
400 gms; a flexibility from about 8 grams to about 40 grams; and a
WVTR from about 1 g/m.sup.2/24 h to about 500 g/m.sup.2/24 h; a
display package comprising: a display surface or an inclined
display surface, defining a first cavity to contain the cosmetic
composition and a second cavity to contain a plurality of barrier
patches.
2. The kit of claim 1 wherein the adhesive release force is about
100 grams to about 200 grams.
3. The kit of claim 1 wherein the WVTR is about 1 g/m.sup.2/24 h to
about 250 g/m.sup.2/24 h.
4. The kit of claim 3 wherein the WVTR is about 2 g/m.sup.2/24 h to
about 20 g/m.sup.2/24 h.
5. The kit of claim 1 wherein the barrier patch is water
impermeable.
6. The kit of claim 1 wherein the barrier patch has a thickness of
about 3 mils to about 15 mils.
7. The kit of claim 6 wherein the barrier layer has a thickness of
about 2 mils to about 15 mils and the adhesive has a thickness of
about 1 mils to about 5 mils.
8. The kit of claim 1 wherein the flexibility is from about 8 grams
to about 25 grams.
9. The kit of claim 1 wherein the pressure sensitive adhesive is
selected from the group consisting of acrylic and methacrylic ester
homo- or copolymers, butyl rubber based systems, silicones,
urethanes, vinyl esters and amides, olefin copolymer materials, and
combinations thereof.
10. The kit of claim 1 wherein the barrier patch is substantially
free of skin active agent.
11. The kit of claim 1 wherein the cosmetic composition and barrier
patch are designed to remain in contact with the target area of
skin for a period of time from about 4 hours to about 24 hours.
12. The kit of claim 1 wherein barrier patch provides a hydration
value from about 35 to about 120.
13. The kit of claim 1 wherein the barrier patch further comprises
a release layer on the surface of the pressure sensitive adhesive
and opposite the backing layer.
14. The kit of claim 1 wherein the cosmetic composition comprises
from about 0.01% to about 10% by weight of vitamin B.
15. The kit of claim 14 wherein the cosmetic composition further
comprises niacinamide, glycerine, tocopherol acetate, D-panthenol,
and combinations thereof.
16. The kit of claim 1 wherein the skin active agent comprises from
about 0.01% to about 10% of a skin active agent selected from the
group consisting of vitamin E, vitamin A,
palmitoyl-lysine-threonine,
palmitoyl-lysine-threonine-threonine-lysine-serine,
N-undecyl-10-enoyl-L-phenylalanine, retinyl propionate, N-acetyl
glucosamine, vitamin C, tretinoin, salicylic acid, benzoic acid,
benzoyl peroxide, tretinoin, and combinations thereof.
17. The kit of claim 1 wherein the barrier patch is essentially
free of a non-woven material.
18. The kit of claim 1 wherein the second cavity further comprises
one or more retention tabs.
19. The kit of claim 1 wherein the barrier patches are provided in
sheet unit dose form.
20. The kit of claim 19 wherein the sheet unit dose form comprises
no more than 2 barrier patches.
21. The kit of claim 1 wherein the cosmetic composition is housed
in a container and the first cavity comprises a substantially
identical dimension or geometric shape of the cosmetic composition
container.
22. The kit of claim 1 wherein the first cavity further comprises a
removal aid to assist in the removal of the cosmetic composition
container from the first cavity.
23. The kit of claim 1 wherein the display package further
comprises: a top cover having a front wall, a back wall and two
sidewalls; a base having a front wall, a back wall and two
sidewalls; an intermediate surround window positioned between said
top cover and said base.
24. The kit of claim 1 wherein the cosmetic composition may either
be positioned substantially within the first cavity or positioned
in an upright position in the first cavity.
25. The kit of claim 23 wherein the edges of the front wall, back
wall and two sidewalls of the top cover are configured to mate with
the edges of the front wall, back wall and two sidewalls of the
base when the intermediate surround window is removed to provide a
close fitting relationship.
26. The kit of claim 1 wherein the display package further
comprises a top cover having a front wall, a back wall and two
sidewalls wherein the front wall further comprises an opening
tab.
27. The kit of claim 1 wherein display package further comprises an
opening tab to aid in opening or closing the display package.
28. The kit of claim 27 wherein the display package further
comprises a top lid comprising an opening flap that is configured
to be seated into a closure slot when the top lid is closed.
Description
TECHNICAL FIELD
[0001] The present invention relates to method of delivering
cosmetic compositions to a target area of the skin via the use of a
barrier patch. The barrier patch comprises a backing layer and a
pressure sensitive adhesive. The barrier patch has improved
properties that provide greater comfort in use, long lasting
adhesion, ease of removal, more efficient delivery of skin care
agents to the skin, and that affords greater formulation
flexibility.
BACKGROUND OF THE INVENTION
[0002] The benefits of using a patch or mask device comprising skin
agents to cosmetically treat the skin, have been recognized in the
art. Cosmetic patches or devices are commercially marketed or
described as being useful for the delivery of skin care actives.
Patches have also been described in the literature and marketed in
the medical field as a useful means for the transdermal
administration of drugs.
[0003] However, many patches or devices suffer drawbacks in their
physical product forms resulting in undesirable in-use
characteristics as perceived by the wearer. For example, some
patches are too wet or sticky. A patch and/or device that comprises
gel forming agents may not form a solid gel structure and as a
result, are difficult to handle and apply to the skin. Other
patches are dry, rough, and inflexible and thus are tight and
uncomfortable to wear. These patches often do not conform well to
the contours of the skin surface to which they are applied. Some
patches or devices, on the other hand, are too flexible. These
patches are thus difficult to handle and apply and may actually
conform too closely to the contours of the skin emphasizing
wrinkles or even inducing wrinkles. Some patches and devices are
difficult to remove and leave behind residue after removal due to
their high adhesive and/or cohesive properties.
[0004] Moreover, patches and devices are also known where the
active agents are incorporated into the adhesive materials in the
patch. Thus these patches serve as a delivery substrate for the
actives. Incompatibility between the skin agents and the adhesive
materials may result in ineffective partitioning of the skin agents
through the adhesive layer. This may lead to inferior penetration
of the skin agents into the layers of the skin. Thus some patches
or devices also do not provide an effective release and penetration
of skin care benefit agents.
[0005] Consumers desire products that provide targeted skin care
effectiveness. These products often require more complex regimens
which may require the use of multiple components such as one or
more liquid compositions and other implements that deliver the
composition to target areas of the skin most needing treatment. For
the beauty-conscious consumer, a normal daily routine may include
the use of 4 to 8 different products every morning and evening.
While products with multiple components may increase the complexity
of the beauty regimen, on the other hand they may provide more
customized and targeted treatment and thus enhance overall efficacy
for each unique consumer.
[0006] Also, skin care manufacturers want to provide skincare
packages that will give consumers the most effective,
solution-oriented, enjoyable and convenient experience when using a
product. Complex regimens may impact compliance, and the lack of
compliance of the beauty regimen can lead to poor overall product
performance and lower overall consumer dissatisfaction. Thus skin
care packaging must ensure that these products with complex
regimens are easy and convenient to use. Skincare packaging also
needs to effectively communicate all of the features and benefits
of the product such as effectiveness, immediate results, quality,
and ease of use.
[0007] It has now been found that a user's satisfaction may be
improved by rebalancing the properties of the barrier patch. By
selecting the proper degree of flexibility, adhesive strength for
ease of removal, occlusion and permeability, skin active agents are
effectively delivered to the skin, and a superior in use experience
is provided for the consumer. Furthermore, some of the embodiments
herein allow greater formulation flexibility, for example, by
allowing the incorporation of a broader range of skin active
agents, which would otherwise interact with the adhesive
material.
[0008] In addition there is a need to reduce the complexity of the
normal daily skin care routine while improving overall compliance
and consumer satisfaction for targeted skin care regimens and
products. Therefore a functional and aesthetically acceptable
product and package that is suitable for simplifying beauty
regimens is provided herein.
SUMMARY OF THE INVENTION
[0009] In accordance with one embodiment, a method of treating skin
is provided comprising:
a. applying a cosmetic composition to a target area of the skin,
comprising an effective amount of a skin active agent, in an
embodiment the skin active agent is provided as a separate
component from a barrier patch; b. applying the barrier patch to
the target area of skin, the barrier patch comprising a backing
layer having a first surface; a pressure sensitive adhesive in
contact with the first surface; adjusting the properties of the
barrier patch to have: an adhesive release force of about 50 gms to
about 400 gms; a WVTR from about 1 g/m.sup.2/24 h to about 500
g/m.sup.2/24 h; in another embodiment from about 1 g/m.sup.2/24 h
to about 180 g/m.sup.2/24 h and a flexibility from about 8 grams to
about 40 grams.
[0010] In an embodiment the cosmetic composition is maintained in
contact with the target area of skin via the barrier patch, for a
period of time from about 2 hours to about 1 week and/or from about
2 hours to about 12 hours.
[0011] In accordance with another embodiment, a method of treating
skin is provided comprising:
a. applying a cosmetic composition to a target area of the skin,
comprising an oil in water emulsion with an effective amount of a
skin active agent that is provided as separate component from a
barrier patch; b. applying the barrier patch comprising:
[0012] a backing layer having a first surface;
[0013] a pressure sensitive adhesive in contact with the first
surface;
[0014] adjusting the properties of the barrier patch to have:
[0015] an adhesive release of from about 75 gms to about 350 gms;
[0016] a WVTR from about 1 g/m.sup.2/24 h to about 180 g/m.sup.2/24
h; [0017] a flexibility from about 8 grams to about 25 grams.
[0018] In accordance with another embodiment, a method of treating
skin is provided comprising:
a. applying a cosmetic composition to a target area of the skin,
comprising an effective amount of a skin active agent that is
provided as separate component from a barrier patch; b. applying
the barrier patch comprising:
[0019] a backing layer having a first surface;
[0020] a pressure sensitive adhesive in contact with the first
surface;
[0021] adjusting the properties of the barrier patch to have:
[0022] an adhesive release force of about 50 gms to about 400 gms;
[0023] a WVTR from about 1 g/m.sup.2/24 h to about 500 g/m.sup.2/24
h; [0024] a flexibility from about 8 grams to about 40 grams; and
adjusting the barrier patch to provide a hydration value of about
35 to about 120.
[0025] In further embodiments, a skin care kit is provided
comprising:
a cosmetic composition comprising an effective amount of a skin
active agent; a barrier patch comprising a backing layer having a
first surface and a pressure sensitive adhesive in contact with the
first surface; the barrier patch comprising an adhesive release
force of from about 50 gms to about 400 gms; a flexibility from
about 8 grams to about 40 grams; and a WVTR from about 1
g/m.sup.2/24 h to about 500 g/m.sup.2/24 h; a display package
comprising:
[0026] a display surface or an inclined display surface, defining a
first cavity to contain the cosmetic composition and a second
cavity to contain a plurality of barrier patches.
[0027] In another embodiment the display package further comprises
a top cover having a front wall, a back wall and two sidewalls; a
base having a front wall, a back wall and two sidewalls; an
intermediate surround window positioned between said top cover and
said base. The cosmetic composition may either be positioned
substantially within the first cavity or positioned in an upright
position in the first cavity. The edges of the front wall, back
wall and two sidewalls of the top cover may be configured to mate
with the edges of the front wall, back wall and two sidewalls of
the base when the intermediate surround window is removed to
provide a close fitting relationship.
[0028] The cosmetic compositions in any of the embodiments of this
summary may comprise an aqueous cosmetic composition.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] While the specification concludes with claims that
particularly point out and distinctly claim the invention, it is
believed that the present invention will be better understood from
the following description of embodiments, taken in conjunction with
the accompanying drawings in which:
[0030] FIG. 1 is a perspective view of a barrier patch, as shown
and described herein.
[0031] FIG. 2 is a top plan view of the barrier patch of FIG. 1, as
shown and described herein.
[0032] FIG. 3 is a cross section of an alternative barrier patch,
as shown and described herein.
[0033] FIG. 4 is a perspective side view of an embodiment of the
display package.
[0034] FIG. 5 is a perspective side view of another embodiment of a
display package.
[0035] FIG. 6 is a perspective side view of another embodiment of a
display package.
[0036] FIG. 7 is a perspective side view of another embodiment of a
display package.
[0037] FIG. 8 is a graph showing the effect of occlusion on skin
hydration.
DETAILED DESCRIPTION OF THE INVENTION
[0038] While the specification concludes with the claims
particularly pointing out and distinctly claiming the invention, it
is believed that the present invention will be better understood
from the following description.
[0039] All percentages and ratios used herein are by weight of the
total composition and all measurements made are at 25.degree. C.,
unless otherwise designated. All numeric ranges are inclusive of
narrower ranges; delineated upper and lower range limits are
interchangeable to create further ranges not explicitly
delineated.
[0040] The compositions of the present invention can comprise,
consist essentially of, or consist of, the essential components as
well as optional ingredients described herein. As used herein,
"consisting essentially of" means that the composition or component
may include additional ingredients, but only if the additional
ingredients do not materially alter the basic and novel
characteristics of the claimed compositions or methods.
[0041] The term "apply" or "application" as used in reference to a
composition, means to apply or spread the compositions of the
present invention onto a substrate such as the human skin surface
or epidermis.
[0042] The term "dermatologically acceptable," as used herein,
means that the compositions or components thereof so described are
suitable for use in contact with mammalian keratinous tissue
without undue toxicity, incompatibility, instability, allergic
response, and the like.
[0043] The term "facial skin surface" as used herein refers to one
or more of forehead, periorbital, cheek, perioral, chin, and nose
skin surfaces. While facial skin surfaces are of concern and are
exemplified herein, other skin surfaces may be treated with the
compositions and methods of the present invention, for example,
surfaces typically not covered by clothing such as facial skin
surfaces, hand and arm skin surfaces, foot and leg skin surfaces,
and neck and chest skin surfaces (for example, deolletage).
[0044] The term "keratinous tissue," as used herein, refers to
keratin-containing layers disposed as the outermost protective
covering of mammals (for example, humans, dogs, cats, etc.) which
includes, but is not limited to, skin, mucosa, lips, hair,
toenails, fingernails, cuticles, hooves, etc.
[0045] The terms "topical application", "topically", and "topical",
as used herein, mean to apply (for example, spread, spray) the
compositions of the present invention onto the surface of the
keratinous tissue.
[0046] As used herein, "effective amount" means an amount of a
compound or composition sufficient to significantly induce a
positive keratinous tissue benefit, including independently or in
combination with other benefits disclosed herein. This means that
the content and/or concentration of agent in the formulation is
sufficient that when the formulation is applied with normal
frequency and in a normal amount, the formulation can result in the
treatment of one or more undesired keratinous tissue conditions
(for example, skin wrinkles). For instance, the amount can be an
amount sufficient to inhibit or enhance some biochemical function
occurring within the keratinous tissue. This amount of the skin
care agent may vary depending upon the type of product, the type of
keratinous tissue condition to be addressed, and the like.
[0047] The term "safe and effective amount" as used herein means an
amount of a compound or composition sufficient to significantly
induce a positive benefit, preferably a positive keratinous tissue
appearance, including independently or in combinations with the
benefits disclosed herein, but low enough to avoid serious side
effects, i.e., to provide a reasonable benefit to risk ratio,
within the scope of sound judgment of the skilled artisan.
[0048] As used herein, "transparent" or "visibly clear" is defined
as having the property of transmitting light without appreciable
scattering so that bodies lying behind are perceivable. One
acceptable test method for determining whether a product is clear
or transparent is according to the method provided herein.
[0049] The term "translucent", as used herein may include
"frosted", "glittered", "pearlescence" and the like and is defined
herein as the practice of inducing a low level of light scattering
into an otherwise "clear" material causing the material to become
matted in appearance.
[0050] As used herein, the term "water impermeable" includes
materials or objects through which water in its liquid state does
not pass.
Barrier Patch
[0051] In an embodiment a skin care product or kit is provided
herein comprising a cosmetic composition comprising an effective
amount of a skin active agent and a barrier patch comprising a
backing layer having a first surface and a pressure sensitive
adhesive in contact with the first surface; the barrier patch
comprising an adhesive release force of from about 50 gms to about
400 gms; a flexibility from about 8 grams to about 40 grams; and a
WVTR from about 1 g/m.sup.2/24 h to about 500 g/m.sup.2/24.
[0052] In an embodiment the method may comprise:
a. applying a cosmetic composition to a target area of the skin,
comprising an effective amount of a skin active agent; b. applying
a barrier patch to the target area of skin, the barrier patch
comprising:
[0053] a backing layer having a first surface;
[0054] a pressure sensitive adhesive in contact with the first
surface;
[0055] adjusting the properties of the barrier patch to have:
[0056] an adhesive release force of about 50 gms to about 400 gms;
a WVTR of about 1 g/m.sup.2/24 h to about 500 g/m.sup.2/24 h; and a
flexibility of about 8 grams to about 40 grams.
[0057] An exemplary embodiment of the barrier patch 1 is shown in
FIGS. 1 and 2. The barrier patch comprises a backing layer 2 and a
pressure sensitive adhesive 3. The backing layer has a first
surface 5 and a second surface 6. The pressure sensitive adhesive 3
is in contact with at least part of the first surface 5 of the
backing layer 2 to form a pressure sensitive adhesive coated region
7 of the first surface 5. In the embodiment of FIGS. 1 and 2, the
barrier patch 1 is rectangular, however this shape is not intended
to limit the invention.
[0058] A cross section of another exemplary embodiment of a subject
barrier patch is shown in FIG. 3 and includes a backing layer 10, a
pressure sensitive adhesive 11, and a release layer 12.
[0059] The backing layer of the barrier patch of the present
invention may comprise a solid sheet material. The sheet provides
the primary structure and shape to the patch, allowing it to be
handled and applied for treatment of a specific target area of the
skin.
[0060] The barrier patches have a size and shape adapted to conform
to a desired target area of skin which could be a human face or
part thereof, legs, hands, arms, feet, or human torso. They may be
generally flat in appearance.
[0061] The exact size and shape of the barrier patch will depend
upon the intended use and product characteristics. The barrier
patch herein can be, for example, a square, circle, semicircle,
rectangle, triangle, oval, ring, crescent, crescent with rounded
corners, teardrop or other more complex and irregular shape. The
shape of the barrier patch may be selected from the group
consisting of circle, square, rectangle, triangle, and/or irregular
shape that conforms to the contours of the forehead, perioral,
and/or periorbital areas of the human face.
[0062] For a barrier patch shaped to fit the face or other target
area of skin, the surface area of the barrier patch may range from
about 0.25 cm.sup.2 to about 1000 cm.sup.2, and/or from about 1
cm.sup.2 to about 500 cm.sup.2, and/or from about 1 cm.sup.2 to
about 200 cm.sup.2, and/or from about 1 cm.sup.2 to about 50
cm.sup.2, and/or from about 5 cm.sup.2 to about 15 cm.sup.2.
Surface area refers to that of a flat plane having the same
boundary as the surface i.e. ignoring any surface texturing
present.
[0063] In an embodiment, the barrier patch typically has an average
thickness ranging from about 0.5 mils to about 100 mils, in
alternative embodiments the barrier patch has a thickness of about
1 mils to about 35 mils and/or about 2 mils to about 30 mils and/or
an average thickness of from about 3 mils to about 15 mils.
[0064] In certain embodiments the barrier patch is substantially
free of, comprises only non-effective amounts of, or is void of, a
skin active agent. As such, the barrier patch of the present
invention may be characterized as a "blank" barrier patch. In this
regard, in an embodiment an effective amount of the skin active
agent employed is a separate component from the barrier patch.
[0065] In certain embodiments, the barrier patch comprises a
backing layer. According to one embodiment, the barrier patch or
backing layer is a film having a WTVR value between about 1
g/m.sup.2/24 h to about 500 g/m.sup.2/24 h, and in another
embodiment has a WVTR from about 1 g/m.sup.2/24 h to about 250
g/m.sup.2/24 h and/or from about 1 g/m.sup.2/24 h to about 180
g/m.sup.2/24 h and/or from about 2 g/m.sup.2/24 h to about 150
g/m.sup.2/24 h and/or from about 2 to about 20 g/m.sup.2/24 h. The
term WTVR stands for "Water Vapor Transmission Rate" and is
measured according to the methods herein.
[0066] The backing layer in certain embodiments is non-porous or
impermeable to water. Thus in an embodiment the barrier patch or
backing layer is water impermeable. In certain other embodiments
the backing layer is impermeable to the cosmetic composition, the
skin care active agent employed, and fluids wherein the WVTR is
from about from about 2 to about 100 g/m.sup.2/24 h. While not
being bound by theory using a substrate that prevents water loss
from the cosmetic composition while the cosmetic composition is in
contact with the keratinous tissue and skin, prevents the cosmetic
composition from drying out. Water loss from the cosmetic
composition may lower the water concentration, may destabilize an
emulsion if present, and may increase the concentration of skin
active agents. This may result in reduced or loss of efficacy
and/or irritation to the skin.
[0067] Such relative water impermeability and lower water vapor
permeability of the backing layer and barrier patch may increase
the effectiveness and efficiency of the cosmetic composition used
with the barrier patch. For example, without being bound by theory,
the water impermeability and lower water vapor permeability of the
backing layer and/or barrier patch employed may serve to enhance or
increase the penetration of the skin care active agent into the
skin.
[0068] In certain embodiments the liquid-impermeable and breathable
backing layer and barrier patch may, for example, consist of a
perforated polyethylene film, where the size of the holes has been
chosen so that air and vapor may pass, but not liquid molecules.
Breathable materials can, as mentioned above, consist of perforated
plastic films. One example of such film is described in U.S. Pat.
No. 5,628,737. The backing layer may also consist of micro-porous
plastic films, as is described in, for example, EP-A-0238200.
[0069] In one embodiment the barrier patch is polyethylene film
sold under the tradename, 1525L, available from 3M, St. Paul, Minn.
No. 1525-L has a backing of polyethylene film of approximately 3
mil thickness, a 1.4 mil thick hypoallergenic, pressure sensitive
acrylate adhesive layer and a paper release layer coated with
polyethylene and silicone.
[0070] In certain embodiments, the backing layer is generally made
of a flexible material which is capable of remaining fitted and
flexing during the movement of the human body and movements
associated with facial expressions or gestures. By "flexible" it is
meant that the backing layer may be substantially bent or folded
without breaking, tearing, ripping, etc. The barrier patch
comprises a flexibility from about 8 grams to about 40 grams and/or
about 8 grams to about 25 grams, and/or from about 10 grams to
about 25 grams, and/or from about 2 grams to about 10 grams. This
degree of flexibility of the barrier patch is selected in
combination with the thickness, WVTR, and adhesion release
properties, to ensure that desirable conformability and comfort are
obtained. The barrier patch also does not collapse or fold under
gravity or upon handling and application by the user. It is
desirable for the barrier patch to conform to the target area of
the skin surface to which it is applied without folding, crinkling,
or inducing more wrinkling of the target area of the skin.
Accordingly, the barrier patch is readily conformable to the skin
and remains flexible throughout the duration of use, as the user
moves during the period of time worn. In an embodiment, the
flexibility is substantially constant for the entire period of time
that the barrier patch is worn by the user.
[0071] Since the thickness of the barrier patch will influence
flexibility, the substrate thickness should be selected that
enables the desired flexibility of the barrier patch to be
achieved.
[0072] The backing layer of the barrier patch may comprise at least
one material, for example, a water impermeable and water vapor
permeable material, that includes but is not limited to
polypropylene (PP); polyethylene (PE, including HDPE and LLDPE);
polyethylene terephthalate (PET); polyvinylchloride (PVC);
polyamide (PA); polycarbonate; polyurethane; cellulose acetate;
polychloropene; polysulfone; polytetrafluoroethylene (PTFE);
polyvinyl acetate (PVA); polyethylene glycol terephthalate film;
polystyrene; polyphenylene oxide (PPO); acrylonitrile butadiene
styrene (ABS); acrylic; acrylonitrile styrene acrylate (ASA);
ethylene vinyl alcohol (EVA); natural rubber, latex, nylon,
nitrile, silicone and thermo plastic elastomers (TPE), and
combination thereof. The backing layer may comprise a single
polymer or mixtures of polymers or copolymers. The barrier patch
may comprise a polyolefin, and/or a high density polyethylene.
Laminates of these materials may also be used. The materials also
may be coextruded. In one embodiment the backing layer or barrier
layer is substantially free of a non-woven material.
[0073] In one embodiment, to provide for a less visible and less
conspicuous barrier patch, the barrier patch is transparent,
translucent, and/or visibly clear. One acceptable test method for
determining whether a product is clear or transparent is according
to the method provided herein which determines the transparency
threshold. In one embodiment the barrier patch is transparent and
in other embodiment the barrier patch has a transparency threshold
from about 1 point to about 10 point, and/or about 1 point to about
4 point, and/or no greater than about 10 point, and/or no greater
than about 4 point.
[0074] The cosmetic composition and barrier patch, for example, may
remain in contact with the target area of skin for a period of time
from about 2 hours to about 1 week. Once the period of time has
elapsed, the barrier patch is removed by peeling it away from the
target area of the skin so that upon removal, the barrier patch is
removed intact, i.e., no backing layer material is left on the
target area of the skin.
[0075] The balance of properties of the barrier patch enables it to
be easily and non-traumatically removed from the target area of
skin. In certain embodiment the adhesive release force is from
about 50 grams to about 400 grams, in another embodiment is from
about 75 grams to about 350 grams, and in another embodiment is
from about 100 grams to about 200 grams. If the adhesive release
force is too low, then the patch does not remain adhered to the
target area of skin for the full extended wearing time. If the
adhesive release force is too high, the removal of the patch at the
end of the wearing period is either painful or is traumatic to the
skin. The method of determining the adhesive release force is
according to the method herein.
[0076] Without being bound by theory, occlusion from the barrier
patch serves three important purposes. First, by maintaining a
continuously moist environment on the skin, the composition such as
an aqueous composition comprising skin active agents can be kept in
a liquefied or solubilized form to create a sustained delivery
environment compared to traditional gel or lotion carriers alone
that become dried on skin. Also, greater hydration/water content in
the skin can promote a more favorable thermodynamic/physical
environment to enable increased penetration and flux of some
actives through layers of the skin, thereby increasing the delivery
rate or amount of actives residing in the skin. Finally, building a
reservoir of moisture in the skin serves to plump or swell the skin
structure.
[0077] Therefore in one embodiment the method and compositions
herein provide for improved hydration of the target area of skin.
As show in FIG. 8, and according to the Methods provided herein,
the hydration of the target area of skin after 8 hours was from
about 35 to about 120 and/or from about 38 to about 100 and/or
about 40 to about 95 and/or about 45 to about 95. In FIG. 8, A is
3M 2476, B is 3M Medipore H, C is 3M 1525L and D is 3M 9830.
[0078] The barrier patch may be manufactured by any suitable
method, including casting, injection moulding, co-injection
moulding, over moulding, in-mold assembly, compression moulding,
blow moulding, casting thermo or vacuum forming. Where appropriate
the barrier patch may be laminated by heat welding (which may
further include the use of pressure, ultrasonic forces and radio or
high frequencies), co-extrusion; adhesives, electro static
adhesions (such as flocking by fibres) and topical surface
applications.
[0079] A variety of adhesives may be used in the manufacture of the
barrier patch herein. Typically, the adhesive material is a
pressure-sensitive adhesive (PSA) that is suitable for long-term
skin contact, and which should be physically and chemically
compatible with the backing layer and/or additives that are
present. Examples of suitable adhesive materials include, but are
not limited to, the following: acrylic and methacrylic ester homo-
or copolymers, butyl rubber based systems, silicones, urethanes,
vinyl esters and amides, olefin copolymer materials, natural or
synthetic rubbers, hot-melt adhesives (see, for example, U.S. Pat.
No. 5,387,450); polyethylenes; polysiloxanes; polyisobutylenes;
polyacrylates; polyacrylamides; polyurethanes; plasticized
ethylene-vinyl acetate copolymers; and tacky rubbers such as
polyisobutene, polybutadiene, polystyrene-isoprene copolymers,
polystyrene-butadiene copolymers, and neoprene (polychloroprene)
and combinations thereof.
[0080] The adhesive typically has an average thickness ranging from
about 0.5 mils to about 15 mils, in alternative embodiments about 1
mils to about 5 mils.
[0081] In accordance with one embodiment, a method of making a
barrier patch is provided comprising:
a. laminating a barrier patch by a process selected from the group
consisting of heat welding, ultrasonic force, co-extrusion,
adhesion, electro static adhesion and combinations thereof; the
barrier patch having a first surface; b. applying a pressure a
pressure sensitive adhesive to the first surface; the barrier patch
having an adhesive release force of about 50 gms to about 400 gms;
a WVTR from about 1 g/m.sup.2/24 h to about 500 g/m.sup.2/24 h; in
another embodiment from about 1 g/m.sup.2/24 h to about 180
g/m.sup.2/24 h and a flexibility from about 8 grams to about 40
grams.
Release Layer
[0082] The barrier patch herein may further comprise a protective
release layer removably attached to the pressure sensitive adhesive
side, for example, first surface, of the backing layer and opposite
the second surface of the backing layer. The release layer provides
protection for the pressure sensitive adhesive from the environment
and prior to application by the user.
[0083] The protective release layer may comprise materials
including polymer resins such as polyolefins, for example,
polypropylene (including stratified biaxially oriented
polypropylene (SBOPP)), polyethylene (including LDPE; LLDPE; HDPE;
Metallocene) or polyethylene terephthalate, and combinations
thereof. Alternative materials which may be used include
polyvinylchloride, polyamide, acetyl, acrylonitrile butadiene
styrene, acrylic, acrylonitrile styrene acrylate, ethylene vinyl
alcohol, ethylene vinyl acetate, Nylon, Latex, natural or synthetic
rubbers, polycarbonate, polystyrene, silicone or thermo plastic
elastomer, thermo plastic vulcanate or copolymers of said
materials, and combinations thereof. In an embodiment the
protective release layer may comprise a coating of a non-stick
material. Exemplary non-stick coatings include wax, silicone,
fluoropolymers such as TEFLON.RTM., and fluorosilicones.
[0084] In an embodiment, the protective release layer covers the
entire aforementioned area of pressure sensitive adhesive coated
region of the backing layer. In another embodiment the protective
release layer is water impermeable. In a further embodiment, the
release layer has a mean thickness of at least about 85 microns, or
from about 85 microns to about 150 microns, and/or from about 90
microns to about 120 microns.
[0085] The release layer may optionally extend, in whole or part,
beyond the pressure sensitive adhesive coated region of the backing
layer and/or beyond the backing layer to provide a removal tab that
facilitates ease of removal of the release layer.
Cosmetic Composition
Skin Active Agents
[0086] The compositions of the present invention may comprise a
skin active agent which provides a particular skin care benefit
characteristic of the usage of the skin care product. The skin care
benefit may include benefits related to appearance or make-up of
the skin. The skin care active can provide acute (immediate and
short lived) benefits, or chronic (long term and longer lasting)
benefits.
[0087] The term "skin active agent" as used herein, means an active
ingredient which provides a cosmetic and/or therapeutic effect to
the area of application on the skin. The skin active agents useful
herein include skin lightening agents, anti-acne agents,
emollients, non-steroidal anti-inflammatory agents, topical
anaesthetics, artificial tanning agents, anti-microbial and
anti-fungal actives, skin soothing agents, sun screening agents,
skin barrier repair agents, anti-wrinkle agents, anti-skin atrophy
actives, lipids, sebum inhibitors, sebum inhibitors, skin sensates,
protease inhibitors, anti-itch agents, desquamation enzyme
enhancers, anti-glycation agents, and mixtures thereof. When
included, the present composition comprises a safe and effective
amount of a skin active agent and/or from about 0.001% to about
20%, in another embodiment from about 0.1% to about 10% of at least
one skin active agent.
[0088] The type and amount of skin active agents are selected so
that the inclusion of a specific agent does not affect the
stability of the composition. For example, hydrophilic agents may
be incorporated in an amount soluble in the aqueous phase, while
lipophilic agents may be incorporated in an amount soluble in the
oil phase.
[0089] Other skin active agents purported to exhibit
expression-line relaxing benefits for use in the present invention
include, but are not limited to, Lavandox available from Barnet
Products Corporation; Thallasine 2, available from BiotechMarine;
Argireline NP, available from Lipotec; Gatuline In-Tense and
Gatuline Expression, available from Gattefosse; Myoxinol LS 9736
from BASF Chemical Company, Syn-ake, available from DSM Nutritional
Products, Inc.; and Instensyl.RTM., available from Silab, Inc;
Sesaflash.TM., available from Seppic Inc.
[0090] Skin lightening agents useful herein refer to active
ingredients that improve hyperpigmentation as compared to
pre-treatment. Useful skin lightening agents herein include
ascorbic acid compounds, vitamin B.sub.3 compounds, azelaic acid,
butyl hydroxyanisole, gallic acid and its derivatives,
glycyrrhizinic acid, hydroquinone, kojic acid, arbutin, mulberry
extract, and mixtures thereof. Use of combinations of skin
lightening agents is believed to be advantageous in that they may
provide skin lightening benefit through different mechanisms.
[0091] Ascorbic acid compounds useful herein include ascorbic acid
per se in the L-form, ascorbic acid salt, and derivatives thereof.
Ascorbic acid salts useful herein include, sodium, potassium,
lithium, calcium, magnesium, barium, ammonium and protamine salts.
Ascorbic acid derivatives useful herein include, for example,
esters of ascorbic acid, and ester salts of ascorbic acid.
Particularly preferred ascorbic acid compounds include
2-o-D-glucopyranosyl-L-ascorbic acid, which is an ester of ascorbic
acid and glucose and usually referred to as L-ascorbic acid
2-glucoside or ascorbyl glucoside, and its metal salts, and
L-ascorbic acid phosphate ester salts such as sodium ascorbyl
phosphate, potassium ascorbyl phosphate, magnesium ascorbyl
phosphate, and calcium ascorbyl phosphate. Commercially available
ascorbic compounds include magnesium ascorbyl phosphate available
from Showa Denko, 2-o-D-glucopyranosyl-L-ascorbic acid available
from Hayashibara and sodium L-ascorbyl phosphate with tradename
STAY C available from Roche.
[0092] Vitamin B.sub.3 compounds useful herein include, for
example, those having the formula:
##STR00001##
[0093] wherein R is --CONH.sub.2 (for example, niacinamide) or
--CH.sub.2OH (for example, nicotinyl alcohol); derivatives thereof;
and salts thereof. Exemplary derivatives of the foregoing vitamin
B.sub.3 compounds include nicotinic acid esters, including
non-vasodilating esters of nicotinic acid, nicotinyl amino acids,
nicotinyl alcohol esters of carboxylic acids, nicotinic acid
N-oxide and niacinamide N-oxide. Preferred vitamin B.sub.3
compounds are niacinamide and tocopherol nicotinate, and in another
embodiment is niacinamide. In a preferred embodiment, the vitamin
B.sub.3 compound contains a limited amount of the salt form and is
more preferably substantially free of salts of a vitamin B.sub.3
compound. Preferably the vitamin B.sub.3 compound contains less
than about 50% of such salt, and is more preferably essentially
free of the salt form. Commercially available vitamin B.sub.3
compounds that are highly useful herein include niacinamide USP
available from Reilly.
[0094] Other hydrophobic skin lightening agents useful herein
include ascorbic acid derivatives such as ascorbyl
tetraisopalmitate (for example, VC-IP available from Nikko
Chemical), ascorbyl palmitate (for example, available from Roche
Vitamins), ascorbyl dipalmitate (for example, NIKKOL CP available
from Nikko Chemical); undecylenoyl phenyl alanine (for example,
SEPIWHITE MSH available from Seppic); octadecenedioic acid (for
example, ARLATONE DIOIC DCA available from Uniquema); oenothera
biennis sead extract, and pyrus malus (apple) fruit extract, Water
and Myritol 318 and butylene glycol and tocopherol and sscorbil
tetraisopalmitate and Paraben and Carbopol 980 and DNA/SMARTVECTOR
UV available from COLETICA, magnesium ascorbyl phosphate in
hyaluronic filling sphere available from COLETICA, and mixtures
thereof.
[0095] Other skin active agents useful herein include those
selected from the group consisting of N-acetyl D-glucosamine,
panthenol (for example, DL panthenol available from Alps
Pharmaceutical Inc.), tocopheryl nicotinate, benzoyl peroxide,
3-hydroxy benzoic acid, flavonoids (for example, flavanone,
chalcone), farnesol, phytantriol, glycolic acid, lactic acid,
4-hydroxy benzoic acid, acetyl salicylic acid, 2-hydroxybutanoic
acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic
acid, trans-retinoic acid, retinol, retinyl esters (for example,
retinyl propionate), phytic acid, N-acetyl-L-cysteine, lipoic acid,
tocopherol and its esters (for example, tocopheryl acetate:
DL-.alpha.-tocopheryl acetate available from Eisai), azelaic acid,
arachidonic acid, tetracycline, ibuprofen, naproxen, ketoprofen,
hydrocortisone, acetominophen, resorcinol, phenoxyethanol,
phenoxypropanol, phenoxyisopropanol, 2,4,4'-trichloro-2'-hydroxy
diphenyl ether, 3,4,4'-trichlorocarbanilide, octopirox, lidocaine
hydrochloride, clotrimazole, miconazole, ketoconazole, neomycin
sulfate, theophylline, and mixtures thereof.
[0096] The compositions of the present invention in various
embodiments may comprise N-acyl amino acid compounds. Suitable
N-acyl amino acid compounds include, but are not limited to, N-acyl
phenylalanine, N-acyl tyrosine, their isomers, including their D
and L isomers, salts, derivatives, and mixtures thereof. An example
of a suitable N-acyl amino acid is N-undecylenoyl-L-phenylalanine
and is commercially available under the tradename SEPIWHITE
(Registered trademark) from Seppic (France).
[0097] Skin care agents are also disclosed in US Publication No.
2007/0020220A1, published Jan. 25, 2007, wherein the
components/ingredients are incorporated herein by reference in
their entirety.
[0098] The cosmetic composition may comprise one or more peptides.
Herein, "peptide" refers to peptides containing ten or fewer amino
acids, their derivatives, isomers, and complexes with other species
such as metal ions (for example, copper, zinc, manganese, and
magnesium). As used herein, peptide also refers to both naturally
occurring and synthesized peptides. In one embodiment, the peptides
are di-, tri-, tetra-, penta-, and hexa-peptides, their salts,
isomers, derivatives, and mixtures thereof. Examples of useful
peptide derivatives include, but are not limited to, peptides
derived from soy proteins, palmitoyl-lysine-threonine (pal-KT) and
palmitoyl-lysine-threonine-threonine-lysine-serine (pal-KTTKS,
available in a composition known as MATRIXYL.RTM.)
palmitoyl-glycine-glutamine-proline-arginine (pal-GQPR, available
in a composition known as RIGIN.RTM.), these three being available
from Sederma, France, and Cu-histidine-glycine-glycine (Cu-HGG,
also known as IAMIN.RTM.). In various embodiments the cosmetic
composition may comprise from about 1.times.10.sup.-7% to about
20%, alternatively from about 1.times.10.sup.-6% to about 10%, and
alternatively from about 1.times.10.sup.-5% to about 5% of the
peptide.
[0099] In one embodiment, the skin active agent is niacinamide. In
one embodiment, the agent is a combination of niacinamide,
glycerine, tocopherol acetate, and D-panthenol. Niacinamide may be
included in the composition in an amount between about 1% to about
30 wt %, in another embodiment from about 2% to about 28 wt %, in
another embodiment from about 5% to about 25 w %, and in another
embodiment from about 10% to about 20 wt %. When D-panthenol is
included, it may be present in an amount of about 0.5% to about 5
wt %, or about 0.5% to about 3 wt % and/or about 0.5% to about 2 wt
%. Glycerin may be included as an active in an amount from about 6%
to about 20 wt %, and/or from about 8% to about 15 wt %, and/or
from about 10% to about 15 wt %.
[0100] In various embodiments, the skin active agent is selected
from niacinamide, alone or in combination with one or more of
palmitoyl-lysine-threonine,
palmitoyl-lysine-threonine-threonine-lysine-serine,
N-undecyl-10-enoyl-L-phenylalanine, retinyl propionate, N-acetyl
glucosamine, vitamin C, tretinoin, salicylic acid, benzoic acid,
benzoyl peroxide, tretinoin, and combinations thereof.
[0101] In an embodiment the cosmetic compositions herein may be
aqueous solutions, or emulsions such as oil-in-water emulsions,
water-in-oil emulsions or multiple emulsions having aqueous or oily
external phases. In another embodiment the cosmetic compositions
herein are oil-in-water emulsions.
[0102] In one embodiment to avoid a negative interaction with the
pressure sensitive adhesive, the cosmetic composition comprises
only low levels of silicones of about 0.5% to about 10%, and/or
from about 1% to about 5% and/or the cosmetic composition is
substantially free of silicones. As used herein "silicones" may
refer to those silicones disclosed in US 2007/0020220A1, published
Jan. 25, 2007, Osborne, for example, in paragraphs [0226] to
[0258].
[0103] In one embodiment the cosmetic composition is substantially
free of depilatory agents.
[0104] The cosmetic composition may comprise an effective amount of
a skin active agent having activity to improve visual or aesthetic
appearance of the skin, such as an agent effective to reduce or
diminish the appearance of fine lines and/or wrinkles on human
facial skin or an agent effective to treating existing acne
lesions, reducing redness associated with acne lesions and/or
protecting from formation of acne lesions.
[0105] The methods of treatment, application, regulation, or
improvement disclosed herein may utilize the aforementioned
compositions. Application of the present compositions can occur on
any target area of skin surface of the body. Skin surfaces of the
most concern tend to be those not typically covered by clothing
such as facial skin surfaces, hand and arm skin surfaces, foot and
leg skin surfaces, and neck and chest skin surfaces (for example,
decolletage). In particular, application may be on a facial skin
surface including the forehead, perioral, chin, periorbital, nose,
and/or cheek skin surfaces.
[0106] The step of applying the cosmetic composition to a target
area of skin may be done by localized application to the target
area, for example, an area that contains wrinkles. In reference to
application of the composition, the term "localized", "local", or
"locally" mean that the composition is delivered to the target area
of skin (such as an area of skin containing wrinkles) while
minimizing delivery to skin surface not requiring treatment. The
composition may be applied and lightly massaged into the skin. It
is recognized that localized application does allow for a
reasonable amount of the composition to be applied to areas
adjacent to the wrinkles to be treated (i.e., the composition is
unlikely to be applied or to remain within the boundary of the
wrinkles without some spreading). The form of the composition or
the dermatologically acceptable carrier should be selected to
facilitate localized application. While certain embodiments of the
present invention contemplate applying a composition locally to a
wrinkled area, it will be appreciated that compositions of the
present invention can be applied more generally or broadly to one
or more facial skin surfaces to reduce the appearance of wrinkles
within those facial skin regions.
[0107] The method of treating skin herein may optionally begin with
a cleansing step. The consumer can wash his or her face with a
suitable cleanser (for example, Olay Purifying Mud Lathering
Cleanser, available from The Procter & Gamble Company,
Cincinnati, Ohio), and gently dry his or her skin with a towel.
[0108] While some methods described herein contemplate applying the
compositions of the present invention with an applicator, it will
be appreciated that applicators are not required and the cosmetic
compositions of the present invention can also be applied directly
by using one's finger or in other conventional manners.
Kits
[0109] Also provided herein are kits, where the kits at least
include one or more barrier patches and a cosmetic composition
comprising an effective amount of a skin active agent, as described
herein.
[0110] Thus in an embodiment a skin care kit is provided
comprising:
a cosmetic composition comprising an effective amount of a skin
active agent; one or more barrier patches comprising a backing
layer having a first surface; a pressure sensitive adhesive in
contact with the first surface; an adhesive release force of from
about 50 gms to about 400 gms; a flexibility from about 8 grams to
about 40 grams; and a WVTR from about 1 g/m.sup.2/24 h to about 500
g/m.sup.2/24 h. The kit may comprise a display package comprising a
display surface or an inclined display surface, defining a first
cavity to contain a cosmetic composition and a second cavity to
contain a plurality of barrier patches.
[0111] As shown in FIG. 4 a display package 2 is provided,
comprising a display surface 7 or an inclined display surface
(shown in FIGS. 5 and 6), defining a first cavity 9 to contain the
cosmetic composition and a second cavity 11 to contain a plurality
of barrier patches 15.
[0112] The display package 2 may comprise a top lid 4; a bottom
support tray 5 having a display surface 7, defining a first cavity
9 to contain a cosmetic composition (not shown) and a second cavity
11 to contain a plurality of barrier patches 15; wherein the
cosmetic composition may be positioned substantially within the
first cavity 9.
[0113] In another embodiment the second cavity 11 further comprises
one or more retention tabs 17. As shown in FIG. 4 the retention tab
17 may be positioned closer to the surface of the sheets in unit
dose form 19 or the retention tab 17 may be placed in a vertical
position against the backwall 21 of the second cavity 11 to make
removal of the one or more sheets in unit dose form 19 easier to
remove from the second cavity 11.
[0114] In an embodiment the display package 2 contains a plurality
of sheets in unit dose form 19 wherein each sheet comprises no more
than 2 barrier patches 15, as shown in FIG. 4. Moreover, the first
cavity 9 may comprise a substantially identical dimension and/or a
substantially identical geometric shape of the container for the
cosmetic composition.
[0115] In further embodiments shown in FIG. 4 the display package 2
may have a first cavity 9 comprising a removal aid 23 to assist in
the removal of the cosmetic composition from the first cavity 9.
The removal aid 23 may comprise a gap in one end of the first
cavity 9 to provide an open area so that a user may be able to
insert his or her fingertip into the gap in order to remove a
cosmetic composition, that is positioned substantially within the
first cavity, from the first cavity 9.
[0116] The display package 2 may also comprise an opening tab 25 to
aid in opening or closing the display package 2. The top lid 4 may
further comprise an opening flap 27 that is configured to be seated
into the closure slot 29 when the top lid is closed. Use
instructions 31 may also be present on the inside surface of the
top lid 4. The opening tab 25 may be a formed from the opening flap
27.
[0117] FIG. 5 shows another embodiment of the skin care kit 1
comprising: a cosmetic composition 3 comprising an effective amount
of a skin active agent. The skin care kit further comprises a
barrier patch 15 comprising a backing layer having a first surface
and a pressure sensitive adhesive in contact with the first
surface; a WVTR from about 1 g/m.sup.2/24 h to about 500
g/m.sup.2/24 h; the barrier patch optionally further comprising an
adhesive release force of from about 50 gms to about 400 gms and
optionally further comprises a flexibility from about 8 grams to
about 40 grams.
[0118] The display package 2 of FIGS. 5 and 6 may comprise a top
cover 6 having a front wall 8, a back wall 10 (not shown) and two
sidewalls 12; the top cover 6 further comprising edges 14 of the
front wall 8, a back wall 10 and two sidewalls 12. The display
package 2 of FIGS. 5 and 6 may also comprise a base 18 having a
front wall 20, a back wall 22 (not shown) and two sidewalls 26; an
intermediate surround window 16 that may be at least partially
transparent; an inclined display surface 34, wherein the
intermediate surround window 16 and the inclined display surface 34
are positioned between said top cover 6 and said base 18. The
inclined display surface 34 may define a first cavity 40 to contain
a cosmetic composition 3 and a second cavity 38 to contain a
plurality of barrier patches 15.
[0119] As shown in FIGS. 5 and 6, in an embodiment the barrier
patches 15 are provided in one or more sheet unit dose forms 44
wherein, for example, the sheet unit dose forms 44 comprise no more
than 2 barrier patches 15. The second cavity 38 may also comprise
one or more retention tabs 42 that prevent or minimize the sheet
unit dose forms from sliding out of the second cavity 38.
[0120] In an embodiment the cosmetic composition (or container
holding the cosmetic composition) 3 may either be positioned
substantially within the first cavity 40 wherein the first cavity
is configured to house the cosmetic container, or the first cavity
40 may be configured to house the cosmetic composition 3 in an
upright position in the first cavity 40. In an embodiment in FIG. 6
the first cavity 40 may further comprise a receptacle 46 which may
enable the cosmetic composition (or container) to be positioned in
an upright position relative to the display surface or the inclined
display surface 34. Moreover, in the same first cavity the cosmetic
composition may also be stored in a position substantially parallel
to the display surface or inclined display surface.
[0121] The skin care kit 1 may further comprise edges 14 of the
front wall 8, back wall 10 and two sidewalls 12 of the top cover 6
that are configured to mate with the edges 28 of the front wall 20,
back wall 22 and two sidewalls 26 of the base 18 when the
intermediate surround window 16 is removed, to provide a close
fitting relationship between the edges 14 of the top cover 6 and
the edges 28 of the base 18.
[0122] In another embodiment the second cavity 38 further comprises
one or more retention tabs 42 to maintain the sheet unit dose forms
44 of the barrier patches 15 in place so that the sheet unit dose
forms of the barrier patches do not side relative to the inclined
display surface 34.
[0123] As shown in FIG. 7, in an embodiment the skin care kit 1 may
comprise edges 14 of the front wall 8, back wall 10 and two
sidewalls 12 of the top cover 6 that are configured to mate with
the edges 28 of the front wall 20, back wall 22 and two sidewalls
26 of the base 18 when the intermediate surround window 16 is
removed, to provide a close fitting relationship between the edges
14 of the top cover 6 and the edges 28 of the base 18. The top
cover 6 may be transparent or opaque.
[0124] In an embodiment the first cavity 40 comprises a
substantially identical dimension and/or geometric shape of the
cosmetic composition (or container) 3.
[0125] As used herein "a sheet unit dose form" means one or a
plurality of sheets (for example, continuous film sheets), that may
have, for example, from about 1 to about 6, barrier patches.
Moreover, the sheet unit dose form may serve as the release layer
for the barrier patch.
[0126] In an embodiment one or more barrier patches may be sealed
in an individual package so that one barrier patch or a relatively
smaller number may be removed from the packaging and used while the
packaging of any other barrier patches of the kit remain intact or
un-breached.
[0127] As mentioned above, the kits may also include a cosmetic
composition, for example, an aqueous cosmetic composition,
comprising an effective amount of a skin active agent. The dosage
amount of formulation provided in a kit may be sufficient for a
single application or for multiple applications. Accordingly, in
certain embodiments of the subject kits a single dosage amount of
the skin active agent is present in a kit. For example, a kit may
include a single barrier patch and a single dosage amount of the
cosmetic composition.
[0128] In certain other embodiments, multiple dosage amounts of the
cosmetic composition may be present in a kit. For example, a kit
may include a plurality of barrier patches and multiple dosage
amounts of the cosmetic composition. In those embodiments having
multiple dosage amounts of the cosmetic composition, such may be
packaged in a single container, for example, a single tube, bottle,
vial, and the like (as shown in FIG. 5), or one or more dosage
amounts may be individually packaged such that certain kits may
have more than one container of a cosmetic composition. In this
instance the inclined display surface 34 or the display surface 7
may have one or more first cavities to contain each of the cosmetic
compositions or to contain multiple cosmetic compositions. In one
embodiment the number of dosage amounts of the cosmetic composition
and the number of barrier patches are the same.
[0129] In certain other embodiments, the kit comprises multiple
barrier patches that are of a size and shape to treat different
areas of the face such as for the treatment of age spots, the
forehead, the under eye area and the under eye area combined with
the crows feet area around the eye.
[0130] The subject kits also generally include instructions for how
to use the barrier patch to occlude the cosmetic composition in
order to deliver the skin active agent to a target area of the
skin. In one embodiment the kit includes instructions to provide an
effective amount of a skin active agent to the target area of skin
that will provide a layer of the cosmetic composition having a
thickness from about 10 microns to about 30 microns and/or from
about 12 microns to about 25 microns. In another embodiment the kit
includes instructions to provide from about 0.5 mg/cm2 to about 3
mg/cm2 of the cosmetic composition, and/or from about 1 mg/cm2 to
about 2 mg/cm2 to the target area of skin. In one embodiment and
without being bound by theory, the use of the proper amount of the
cosmetic composition will minimize the interaction of the cosmetic
composition with the pressure sensitive adhesive.
Test Methods
WVTR
[0131] WVTR of the barrier patch is measured according to ASTM
F1249 at 37.degree. C. and 35% RH. Samples may be analyzed on a
MOCON Permatran-W 3/33 Water Vapor Permeability Instrument using
ASTM F1249. For samples with higher WVTR (for example, from
approximately 300 g/m.sup.2/24 h to 500 g/m.sup.2/24 h) samples may
be analyzed per ASTM E-96 with desiccant placed inside the test
cups and 35% RH surrounding the exterior of the cups. Samples of
barrier patches are prepared and include the pressure sensitive
adhesive.
Adhesive Release Force
[0132] Adhesion measurements were evaluated with a ChemInstruments
AR1000. Specimens are cut to segments 2 cm wide. One end of a 5
cm-long specimen is placed on a stainless steel test panel and
rolled with a 4.5-lb hand-roller. The specimen then stays in
contact with the plate for a period of 4 hours. The panel is placed
into the instrument at 37.degree. C. and the other end of the
specimen is attached to the grip set at a 180.degree. peel using
Nexcare.RTM. gentle paper tape (3/4'' wide) as a coupler. The speed
is set to 10 in/minute and the measurement is initiated. After data
collection the initial (onset of pull) and final (pull-off) regions
are discarded and the central region where there is constant pull
against the specimen is used to generate an average peel force.
Peel forces from three specimens are averaged to generate a peel
force for each sample.
Transparency
[0133] Transparency is measured by assessing the visibility of
printed text through the barrier patch. The printed text is
prepared by printing the English alphabet (capital letters) onto
transparency film (Universal Office Supplies) using Microsoft Word
Arial font and a LaserJet 4 Plus printer (Hewlett Packard) fitted
with a black ink cartridge. Printed transparency films are prepared
in font sizes ranging from 4 points to 28 points. The printed
transparency films are then laid over white paper sheets to ensure
a uniform background and all samples assessed under normal indoor
lighting conditions, such as retail outlet lighting conditions.
[0134] The word and/or letters must be visible and/or readable by
an individual using unaided 20/20 eyesight and positioned 12 inches
in front of the sample.
[0135] A sample of the barrier patch, including the backing layer
and the pressure sensitive adhesive, of interest is selected. This
sample is placed, pressure sensitive adhesive side facing
uppermost, onto the transparency film printed with 4 font size. The
visibility of the printed text is assessed through the sample. If
the text is not legible through the sample, the sample is
transferred to the next largest font size print and the assessment
repeated. This process is repeated until a font size is reached
that is legible through the sample.
[0136] The smallest font size legible through the sample is then
assigned the "transparency threshold" for that device.
[0137] In one embodiment the "transparency threshold" for the
sample of the barrier patch of the present invention is no greater
than about 10 point, in another embodiment no greater than about 7
point and in yet another embodiment is no greater than about 4
point.
Corneometer Testing
[0138] Improvements in skin hydration may be measured with a
Corneometer, while baseline measurements are taken prior to
application of materials. In particular, skin hydration based upon
measurements of capacitance may be assessed using the Corneometer
(Registered trademark) 825. Use of a Corneometer is further
described in U.S. patent application Ser. No. 13/007,630. Such
measurements can be non-invasive and can be taken in duplicate on
the target area of skin at the following times: At baseline, and 8
hours post-treatment.
[0139] Data can be recorded electronically using direct data entry
and data capture programs. Measurements can be performed according
to a test facility's standard operating procedures and/or the
Instrument Operation Manual.
[0140] The Corneometer values are arbitrary units for electrical
impedance. At baseline, for subjects having a dry skin grade from
about 2.5 to about 4.0, an adjusted mean of such Corneometer values
can typically fall within a range of about 15 to about 20. Higher
Corneometer values can correspond to a higher hydration level, and
thus, lower Corneometer values can correspond to lower hydration
levels. The same instrument(s) and operator(s) can be used
throughout the study.
[0141] The probe can be wiped with a Kimwipe between each
measurement. At the end of an evaluation session, data collected
for that period can be backed up according to instructions in the
Instrument Operation Manual, and a hard copy of the data can be
printed.
Flexibility
[0142] Rigidity or flexibility is measured using a Handle-O-Meter,
model #211, available from Thwing-Albert Instrument Co. of
Philadelphia, Pa. A 100-g beam was used. For the sample, a specimen
was cut to a square of 50 mm width and length. The specimens should
be cut in each of the principle directions of the sample, avoiding
creases and wrinkles. The samples are tested in four positions (one
in each direction and one on each side of the sample), with an
average rigidity reported for the 4 positions. For samples with
adhesive material, a 1 mil polyethylene film was attached to the
sample to cover the adhesive. To account for the effect on
flexibility of the 1 mil polyethylene film used as a cover, the
flexibility of the 1 mil film was tested separately. This
flexibility value was then subtracted from the flexibility value of
the sample without the cover film. For thicker samples, it may be
necessary to cut samples with dimensions smaller that 50
mm.times.50 mm to allow the Handle-O-Meter to be able to depress
the samples into the slot.
EXAMPLES
[0143] The following are non-limiting examples of compositions of
the present invention. The examples are given solely for the
purpose of illustration and are not to be construed as limitations
of the present invention, as many variations thereof are possible
without departing from the spirit and scope of the invention, which
would be recognized by one of ordinary skill in the art.
[0144] In the examples, all concentrations are listed as weight
percent, unless otherwise specified and may exclude minor materials
such as diluents, filler, and so forth. The listed formulations,
therefore, comprise the listed components and any minor materials
associated with such components. As is apparent to one of ordinary
skill in the art, the selection of these minors will vary depending
on the physical and chemical characteristics of the particular
ingredients selected to make the present invention as described
herein.
Examples 1-5
TABLE-US-00001 [0145] Example 1 2 3 Phase A Distilled water qs 100
qs 100 qs 100 Phase B Glycerin 5 5 5 Ti02 0.75 0.75 0.75 Phase C
glycerin 1 1 1 EDTA 0.1 0.1 0.1 Carbopol 954 0.68 0.5 0.5 Carbopol
1382 0.1 0.1 0.1 Phase D Cetyl Alcohol 0.72 0.72 0.72 Stearyl
Alcohol 0.48 0.48 0.48 Stearic Acid 0.1 0.1 0.1 PEG-100 Stearate
0.1 0.1 0.1 Arlatone 2121 1 1 1 Silicone Q21403 2 2 2 Fatty acid
ester of sugar 0.67 0.67 0.67 Tocopherol Acetate 0 0 0.5
Niacinamide 2 2 2 Phase E distilled water 2 2 2 NaOH to neutralize
Carbopols to neutralize to neutralize to neutralize Phase F Urea 2
0 0 D-Panthenol 0 0 0.5 distilled water 5 5 5 Phase G Glydant Plus
0.1 0.1 0.1 Glycerin 1 1 1 distilled water 1 1 1 Phase H Methyl
Isostearate 1.33 0 0 Isopropyl Isostearate 0 1.33 1.33 Retinol 0 0
0.04 BHT 0 0 0.05 Tween 20 0 0 0.04 Example 4 5 Phase A distilled
water qs 100 qs 100 Phase B Glycerin 6 6 Ti02 0.75 0.75 Phase C
Glycerin 3 3 Carbopol 954 0.4 0.4 EDTA 0.1 0.1 Phase D Cetyl
Palmitate 1.5 1.5 Cetyl Alcohol 2.25 2.25 Stearyl Alcohol 1.5 1.5
Stearic Acid 0.31 0.31 PEG-100 Stearate 0.31 0.31 Silicone Wax
DC2501 2 2 DC 3225C 1.88 1.88 Dimethicone 200/350 cst 0.63 0.63
Tocopherol Acetate 0 0.5 Niacinamide 2 2 Phase E distilled water 2
2 NaOH to neutralize Carbopol to neutralize to neutralize Phase F
D-Panthenol 0 0.5 distilled water 0 5 Phase G Glydant Plus 0.1 0.1
distilled water 1 1 glycerin 1 1 Phase H Isopropyl Palmitate 1.25
1.25 Retinol 0 0.04 Tween 80 0 0.04 BHT 0 0.05
[0146] Oil-in-water emulsions are prepared from the ingredients in
these examples using conventional formulating techniques. First,
sparge Phase A ingredients using nitrogen for approximately 15
minutes. Phase B ingredients are milled until the Ti02 is
homogeneously dispersed, and then added to Phase A. Phase C
ingredients are then dispersed into Phase A/B until uniform using
propeller type mixing and heating the mixture to about 75.degree.
C. In a separate vessel, Phase D ingredients are combined and
heated to about 75.degree. C. The mixture of phases A/B/C are then
blanketed with a slow, steady stream of nitrogen. Next the Phase D
ingredients are homogenized into the mixture of phases A/B/C using
any rotor/stator type of homogenizer for approximately 15 minutes.
After the 15 minutes, the mixing is switched to low rpm sweep
mixing. Next, phase E ingredients are combined and added to the
mixture of phases A-D.
[0147] Once phase E is mixed and the batch mixture is homogeneous,
the entire batch mixture is cooled. When the 5 batch is cooled to
about 50.degree. C., phase F ingredients are added and homogenized.
When the batch is cooled to about
[0148] 40.degree. C., phase G ingredients are added to the batch
mixture. Lastly, when the batch mixture is cooled to about
30.degree. C., the phase H ingredients are combined to the batch
mixture. Mixing is continued until the batch mixture is
uniform.
[0149] Delivery of Skin Active Agent to a Target Area of Skin.
[0150] The above compositions 1, 2, 3, 4 and/or 5 are applied via
the fingertips to the periorbital area of the face of a human test
subject to provide from about 0.5 mg/cm2 to about 3 mg/cm2 of the
cosmetic composition to the target area of skin. Thereafter an
exemplary orbital barrier patch for treatment of periorbital skin
aging is attached to periorbital area, covering the cosmetic
composition. The barrier patch is transparent and comprises an
adhesive release force of about 150 grams, a WVTR of about 3
g/m.sup.2/24 h, and a flexibility of about 10 grams. The barrier
patch of the invention is applied and worn for an extended period
of time of approximately 7-8 hours and thereafter removed. The
method herein delivers an effective amount of the skin active agent
in a manner that achieves penetration of the skin active agent into
the stratum corneum, and/or other layers of the epidermis, and in
many embodiments, into the basal skin layer and/or dermis.
Example 6
[0151] A consumer, small-base paired comparison of a patch
prototype, 3M 1525L (C), against a series of other commercial patch
materials was conducted. The commercial patch materials varied in
WVTR, flexibility and adhesive release force values as indicated
below in Table 2. The materials included 9776, 9904, 9916, 2476P
and 2475P, available from 3M.
[0152] Each consumer applied a cosmetic composition. Olay Anti
Wrinkle Results Eye Cream, via the fingertips to the periorbital
area of their face delivering approximately from 0.5 mg/cm.sup.2 to
3 mg/cm.sup.2 of the cosmetic composition to the target area of
skin. After applying the cosmetic composition, the test subjects
applied one of the barrier patches listed below and adhered it to
the periorbital area, covering or overlapping the cosmetic
composition. The barrier patch was worn for approximately 7-9
hours, generally overnight while sleeping, and thereafter removed.
This regimen was repeated for each of five consecutive days. Then
consumers answered a questionnaire about the comfort, ease of use
and performance of the product.
TABLE-US-00002 TABLE 2 Patch 1525L 9776 9904 9916 2476P 2475P
(Sample C) (Sample U) (Sample X) (Sample R) (Sample S) (Sample T)
Thickness 4.4 34 11 15 14.6 4.6 (mil) Backing Polyethylene
Polyethylene Polyurethane Spunlace Spunlace Thermoplastic Layer
nonwoven polyester elastomer Adhesive Acrylate Acrylate Acrylate
Acrylate Silicone Silicone Handle-O- 14.2 106.5 24.9 40.4 13.4 5.5
Meter (g) Peak 352.4 387.5 784 2441 108 77.3 Adhesion (g) WVTR 2.6
15 79 813 225 198 (g/m2-day) Overall Rating.sup.1 Sample C-51
Sample C-36 Sample C-50 Sample C-52 Sample C-55 Sample C-60 Sample
U-48 Sample X-41 Sample R-42 Sample S-52 Sample T-35 .sup.1For the
overall ratings, each Sample was rated and compared to Sample
C.
[0153] Consumers prefer, via the overall rating score, 1525L having
an adhesive force of 352.4 g, a flexibility of 14.2, and a WVTR of
2.6, to all of the other patches with the exception of 9776.
However, 9776 had significantly higher stiffness than 1525L having
a flexibility of 106.5 and consumers rated 9776 less comfortable to
wear. 2475P, the most flexible patch, had the lowest score. It was
difficult to handle and apply by consumers.
[0154] Thus providing barrier patches with the right balance of
adhesion, flexibility, and WVTR properties provides preferred
product attributes. Water Vapor Transmission Rate provides a degree
of occlusion and skin hydration; proper flexibility allows the
barrier patch to conform to face and not interfere with sleep,
while easy to handle and apply; and proper adhesion keep the
barrier patch in place, feels comfortable, and is easily
removed.
[0155] The dimensions and values disclosed herein are not to be
understood as being strictly limited to the exact numerical values
recited. Instead, unless otherwise specified, each such dimension
is intended to mean both the recited value and a functionally
equivalent range surrounding that value. For example, a dimension
disclosed as "40 mm" is intended to mean "about 40 mm."
[0156] Every document cited herein, including any cross referenced
or related patent or application and any patent application or
patent to which this application claims priority or benefit
thereof, is hereby incorporated herein by reference in its entirety
unless expressly excluded or otherwise limited. The citation of any
document is not an admission that it is prior art with respect to
any invention disclosed or claimed herein or that it alone, or in
any combination with any other reference or references, teaches,
suggests or discloses any such invention. Further, to the extent
that any meaning or definition of a term in this document conflicts
with any meaning or definition of the same term in a document
incorporated by reference, the meaning or definition assigned to
that term in this document shall govern.
[0157] While particular embodiments of the present invention have
been illustrated and described, it would be obvious to those
skilled in the art that various other changes and modifications can
be made without departing from the spirit and scope of the
invention. It is therefore intended to cover in the appended claims
all such changes and modifications that are within the scope of
this invention.
* * * * *