WO2000033796A1

WO2000033796A1 - Device, method, and composition for skin cleansing

Info

Publication number: WO2000033796A1
Application number: PCT/US1999/008881
Authority: WO
Inventors: Hock Seng Tan; Suresh Borsadia; William R. Pfister; Spiros Fotinos
Original assignee: Lavipharm Laboratories, Inc.
Priority date: 1998-12-07
Filing date: 1999-04-23
Publication date: 2000-06-15
Also published as: UY25529A1; AU3662899A

Abstract

Compositions, devices and methods for sking cleansing are provided, having a pressure-sensitive adhesive comprising a cationic polymer and a plasticizer. The adhesive can comprise additionally an anti-irritant, a cleansing agent, an antiseptic, a colorant, a filler, an antioxidant, a skin protectant, a moisturizer, a humectant, a porolytic agent, a skin reconditioning agent, a cationic salt, and other components. A device is provided in a ready-to-use format, not requiring wetting of the device, the skin, or addition of water, and can be formulated in the absence of preservatives.

Description

DEVICE, METHOD, AND COMPOSITION FOR SKIN CLEANSING Technical Field

The present invention relates to devices, methods, and compositions for skin cleansing, particularly involving pressure-sensitive skin adhesives.

Background of the Invention Keratotic plugs ("blackheads") are dead epidermal keratinized cells with sebaceous material and exogenous matter such as soot particles or dirt, which plug the pores of the skin. Excessive size and number of keratotic plugs result in conspicuous skin pores, and can lead to additional skin problems. It is advisable to remove the keratotic plugs to improve the health and appearance of the skin. Ordinary facial cleansers such as soaps, detergents and make-up removers, do not effectively remove the plugs.

Peel-off patch preparations require pre- wetting of the patch or the skin for application; after drying, the patch is peeled off to remove keratotic plugs (U.S. Patent 5,512,277 and Japan Patent 09110629 A). Keratotic plug remover compositions are formulated as aqueous solutions, suspensions or dispersions (U.S. Patent No. 5,512,277), and can include keratolytic compounds such as salicylic acid, benzoyl peroxide, and resorcinol, complexed to carrier molecules such as polyamides, polyanilines, and polyurethanes in compositions such as make-up, moisturizing lotion, toner, or cleansing cream (U.S. Patent No. 5,449,519). While termed "keratolytic", these agents are primarily anti-bacterial. Commercial preparations are available from several companies (e.g. Kao/Biore,

Chesebrough-Pond's, and Pacific Corporation). Table 1 is a list of keratotic plug removal products on the market, all of which require water to activate adhesion of the product to skin. These preparations contain film forming water-soluble polymers that require moistening to obtain wet tack properties so that they can adhere to and maintain contact with the skin.

One drawback of water-activated adhesion devices is the inconvenience of addition of water to skin or to the device prior to application. Another disadvantage of these products is the presence of preservatives, which can cause irritation of the skin in some subjects. Further, the stability of these devices can be affected by moisture from

Table 1. Ingredient and Water- Activation Requirement of Commercial Devices manufacturer, product enabling polymers, ingredients adhesion mechanism Kao/Biore polyquaternium-37 water-activated

Pond's PVM/MA polymer, water-activated aminomethyl propanol

Elizabeth Arden PVM/VA polymer, amino water- activated methyl propanol, vitamin C

Advanced Research polyvinyl formamide water-activated

Laboratories

Pacific Corporation polyvinylformamide water-activated

HDS Lab, Inc. polyvinyl alcohol water-activated

Dermal Sciences PVP/VA copolymer, water-activated quaternium salt

CNS polyacrylic acid water- activated

Νeutrogena PVP/VA copolymer, water- activated polyvinyl alcohol

J & J PVP/VA copolymer, water- activated polyvinyl alcohol

Aim ay polyvinylformamide water-activated

Suave PVM/MA polymer, amino water-activated methyl propanol

the environment that diffuses into pouches in which these devices are packaged, making them sticky, gummy, and difficult to handle and use successfully. Additionally, these devices must dry after application to the skin, and the drying process causes a shrinking or tightening of the skin which results in an uncomfortable sensation which is undesirable. Furthermore, the devices are difficult to remove from the skin after application, because one must first pick at an edge of the device with the fingers in order to secure hold of the device, and then one must peel the device from the skin.

Summary of the Invention Various embodiments of the invention described herein include self-adhesive compositions, devices formulated with these compositions, and methods of use of the devices and compositions for removal of non-living matter such as dead skin cells, sebum, dirt, particulates, pore plugs and keratotic plugs, and for removal of living matter such as pollen and microorganisms such as bacteria, fungi, and viruses. An advantage of the compositions and devices in accordance with various embodiments are that they are formulated devoid of water, and the methods are without the use of water to activate adhesion to skin. Further, application to and removal of devices from the skin are made easier by use of an adhesive-free area which forms a tab that is easy to secure with the fingers. Finally, embodiments of the device of the present invention do not shrink or cause discomfort during the period of contact with the skin.

Because a device in accordance with an embodiment of the invention is formulated in the absence of water, it can also be fabricated in the absence of preservatives, and can therefore be non-irritating and hypoallergenic, and can accordingly be used with greater frequency than products containing harsh components such as preservatives. A device which is an embodiment of the invention can be applied to skin of a subject for example twice a day, once a day, once every two or three days, or once a week, as needed by the subject.

Among the various embodiments of the invention described herein are devices for removal of material from the skin of a subject, for example, a device for removal of non-living material from skin of a subject, the device comprising: a support substrate; and a layer of a pressure-sensitive adhesive deposited on the support substrate, the pressure-sensitive adhesive including a cationic polymer and a plasticizing agent. In a preferred embodiment, the cationic polymer is an amino acrylate polymer, for example, an amino acrylate polymer selected from the group consisting of a copolymer of an amino methacrylate; a copolymer of an octylacrylamide, an acrylate, and an amino methacrylate; and a copolymer of a vinylpyrrolidone and a dimethylaminoethyl methacrylate. An embodiment of an amino methacrylate copolymer is selected from the group consisting of poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1:2:1 ; poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride), 1:2:0.2; and poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride), 1 :2:0.1. In a preferred embodiment, the cationic polymer is poly utyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1 :2:1.

An embodiment of the invention which is a composition and a device includes a plasticizing agent, for example, a plasticizing agent selected from the group consisting of a citrate ester, a sebacate, a glycol, an adipate, a phthalate, a phosphate, a mineral oil, a polymeric tackifying agent, trolamine, triacetin, and a phospholipid. Further, the citrate ester is selected from the group consisting of triethyl citrate (TEC), acetyl triethyl citrate (ATEC), acetyl trihexyl citrate (ATHC), tributyl citrate (TBC), and acetyl tributyl citrate (ATBC). In another embodiment, the sebacate is selected from the group consisting of dibutyl sebacate and diethyl sebacate. In a preferred embodiment, the plasticizing agent is ATBC.

An embodiment of the invention which is a device can comprise additionally one or more agents selected from the group consisting of an anti-irritant, a cleansing agent, an antiseptic, a colorant, a filler, an antioxidant, a skin protectant, a humectant, a moisturizer, a porolytic agent, a skin reconditioning agent, a cationic salt, a vitamin, a nutritional supplement, and a skin penetration enhancer. In an embodiment of the invention, the device comprises an anti-irritant, a cleansing agent, and a colorant. In an embodiment of the invention which is a composition, the anti-irritant is selected from the group consisting of α -bisabolol, glycerol, glycyrrhetinic acid, tea tree oil, camomile, Aloe vera extract and green tea extract; and the colorant is selected from the group consisting of titanium dioxide, zinc oxide, silica and alumina. In an embodiment of the device, the anti-irritant is α-bisabolol, the cleansing agent is polyoxyethylene 20 sorbitan monolaurate, and the colorant is titanium dioxide. In a related embodiment, poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1, is present at 40-90% by weight; ATBC is present at 5- 60% by weight; α-bisabolol is present at 0.5-5.0% by weight; and titanium dioxide is present at 0.1-5.0% by weight. According to another embodiment of the device, a support substrate is a backing support of a nonwoven, nonocclusive film of high moisture vapor transmission selected from the group consisting of an acrylic, a polyethylene, a polyolefin, a polyurethane, a polyester, a polyethylene, a polypropylene, a nylon, a cotton, a rayon, a polyvinyl chloride, a silicate fiber glass, and a cellulosic fiber. In another embodiment, a support substrate is a release liner of a material selected from the group consisting of paper, polyester, and polystyrene.

An embodiment of the invention is a device having a water content of less than one percent by weight. A further embodiment of the invention is a device for removal of living material from skin of a subject, the device comprising: a support substrate; and a pressure- sensitive adhesive layer deposited on the support substrate, the pressure-sensitive adhesive including a cationic polymer and a plasticizing agent. The living material is a microorganism selected from the group consisting of a bacterium, a fungus, and a virus. A device according to a further embodiment comprises a microorganism- targeted reagent.

In a further embodiment provided herein, a device for removal of matter from skin of the subject comprises: a backing support; and an adhesive matrix deposited on the backing support, wherein the backing support is provided with a tab without adhesive matrix, for removal of the device from the skin of the subject. The device can further comprise: a release liner, wherein the release liner is provided with a tab without adhesive matrix, for removal of the release liner from the matrix adhesive layer prior to application of the device to the skin of the subject.

An embodiment of the invention provides a method for removing non-living material from skin of a subject, comprising: (a) applying to the skin a pressure- sensitive adhesive composition having a cationic polymer and a plasticizing agent; (b) allowing the mixture to bond to the skin and the non-living material; and (c) removing the composition from the skin. Further according to a method of applying a pressure- sensitive adhesive includes providing a backing support for the adhesive composition, the backing support has a tab including an area of the support which has been sheltered from deposition of pressure-sensitive adhesive composition, wherein removing the composition includes grasping the tab. In another aspect of the method prior to applying the composition to the skin, removing a release liner from the composition includes grasping a tab comprising an area of release liner which has been sheltered from deposition of the pressure-sensitive adhesive.

An embodiment of the invention provides a method for removing living material from skin of a subject, comprising: (a) applying to the skin a pressure-sensitive adhesive composition having a cationic polymer and a plasticizing agent; (b) allowing the mixture to bond to the skin and the living material; and (c) removing from the skin the composition with the living material bonded thereto. An embodiment of the method further comprises detecting and identifying the living material bonded to the composition.

Brief Description of the Drawings Figure 1 is a drawing of cross-sections of embodiments of a device in accordance of the present invention having a tab feature for removal of a release liner and of a backing support. Figure 2 is a drawing of a top view of an embodiment of a bat- shaped device.

Detailed Description of Embodiments Embodiments of the invention provide a self-adhering pressure-sensitive adhesive, preservative-free, keratotic plug remover composition and device which can be used by methods that do not require pre-wetting, which can remove living and non- living particulates, and which can also deliver beneficial ingredients to the skin, to minimize trauma after removal and to recondition the skin and pores. Related embodiments provide a device which does not shrink and cause discomfort, and which is easy to apply and remove from the skin.

In accordance with one embodiment, the invention provides a device utilizing a pressure-sensitive adhesive (PSA) which, when applied to skin and subsequently peeled off, can effectively remove non-living matter such as dead cells, sebum, dirt, soot particles, pore plugs and keratotic plugs, and can also remove living matter such as pollen, bacteria, fungal cells and spores from the surface of the skin, so that the pores are cleansed and resolved and the skin is cleansed and exfoliated. A device which is a further embodiment of the invention can remove non-living material from the skin of a subject, for example, a pore plug which is a keratotic plug and dead keratinocytes of the stratum corneum. Removal of living matter, for example removal of a bacterium that is an etiological agent of a skin infection, for example acne, may reduce progression of the infection at an infected site, and reduce spread to additional sites.

Advantages of embodiments of the invention arise from aspects of the formulation of the PSA matrix. The PSA matrix which is an embodiment of the invention does not need water to activate adhesion to skin, and offer improved convenience and comfort compared to compositions which must be wetted to be applied. The PSA component of the devices contains a cationic polymer to facilitate bonding to the negatively charged non-living and living matter on the surface of the skin. In addition, the devices can deliver beneficial ingredients to the skin to minimize trauma after removal, and recondition the skin and pores. Definitions

As used in this description and in the accompanying claims, the following terms shall have the meanings indicated unless the context otherwise requires. A "subject" is a human having an unwanted pore plug, an unwanted cell, or an unwanted particle of living or non-living matter on the skin (epidermis) of the face, head, neck, shoulder, back or other affected area.

A "pore plug" is an obstruction of a pore. A plug can be obstructed by non-living or living material. A "keratotic plug," commonly known as a blackhead, is a deposit of non-living epidermal keratinized cells with sebaceous materials and exogenous matter, for example, dirt, soot, or microorganisms. Epithelial cells are produced from basal stem cells and undergo several rounds of cell division prior to differentiation. During division, the epithelial cells migrate towards the epidermal surface, and initiate synthesis of the fibrous protein keratin, found in skin, hair and nails. Prolonged deposit of keratin-containing dead skin cells into keratotic plugs can impart a unpleasant hard or sharp texture to the surface of the plug. Oxidation and cross-linking of melanin precursors in the plug impart a dark color. As used here and in the claims, a pore or a keratotic plug is not restricted as to degree of keratinization, or color conferred by variation in melanin deposition.

A "pressure- sensitive adhesive" (PSA) is any device or composition that can adhere to skin of a subject with the application of gentle pressure. The PSA compositions used in embodiments of the invention do not require pre- wetting or moisturizing, rather only light manually-applied pressure, similar to that for applying a disposable adhesive bandage, is required for adhesion to skin. Additional forms of manipulation and palpation are within the scope of the embodiments of the invention. The device is formulated and packaged in a ready-to-use format, having a protective disposable release liner which protects the surface of the PSA during storage and which is removed and discarded at the time of use.

A "cationic" polymer or excipient shall mean a polymer or excipient, respectively, that is positively charged under conditions of use in accordance with an embodiment of the present invention, for example, at a neutral pH or equivalent, or at skin pH. In an embodiment of the invention, the cationic polymer is positively charged because of the presence, as a chemical group of the polymer, of functional amino groups as protonated positively charged ions.

A "support substrate" means a backing support or a release liner upon which a PSA pressure-sensitive adhesive matrix layer comprising pressure-sensitive adhesive polymers can be deposited.

As used here and in the claims, a "plasticizer" or a "plasticizing agent" denotes a chemical composition that confers a sticky and pliable texture to a composition which is an embodiment of the invention. A plasticizing agent and a tackifying agent shall have the same meaning.

"Cleansing" is used here and in the claims to denote removal of living or nonliving matter from the surface of the skin.

"Exfoliation" means removal of non-living cells of the subject from the surface of the skin of the subject. A "porolytic" composition, as used here and in the claims, shall mean a composition or combination of several compositions that removes substantially all of a keratotic plug from a pore, such that the pore is resolved, that is, the pore can resume an appropriate functional shape and size. The porolytic composition may contain a porolytic agent such as an enzyme, a cosolvent, a keratolytic agent, and the like. A "porolytic agent" is a chemical that dissolves, softens, plasticizes, loosens, and assists removal and resolution of a keratotic plug or blackhead. Porolytic enzymes such as trypsin, papain, and the like may be employed. Keratolytic agents such as salicylic acid and resorcinol and the like, as well as α-hydroxy acids and β-hydroxy acids may be employed. Co-solvents and plasticizers having a Hildebrand solubility parameter between 8 and 20 cal^1/2/cm³² may be employed. Other components can be added to the combination that can promote healing and retard resumption of development of a keratotic plug.

PSA matrix compositions

Embodiments of devices and methods of the invention are based on the finding that three characteristics are required of a PSA composition to efficiently remove a plug. The first requirement is good adhesion to skin and to a plug, so that point-by- point contact between the composition and the skin is established and maintained. The second requirement is cold flow or migration of the PSA composition into the crevices, wrinkles, contours and pores of the skin. The third requirement is strong interaction between cationic groups of the PSA composition and anionic constituents of matter such as a plug such as a keratotic plug, so that when the device is peeled from the skin, the keratotic plug is removed along with the composition. A superficial layer of dead skin cells, and other non-living or living matter on the surface of the skin can be simultaneously removed, which exfoliation process causes skin to appear smoother, moister and more light reflective.

The invention provides embodiments which are devices, compositions and methods that satisfy these requirements for efficient removal of a keratotic plug. Thus the inventors have made the surprising discovery that compositions that contain a cationic polymer, such as those that have amino functional groups, and a plasticizing (tackifying) agent, are capable of efficient removal of matter on the skin surface such as a keratotic plug. The devices and compositions are fabricated to contain no water, and addition of water is not required for the methods of use. In a preferred embodiment, the pressure-sensitive adhesive matrix layer can have a water content of less than one percent by weight, for example, 0.9%, 0.5%, or 0.1% water by weight. Cationic polymers, and plasticizers An embodiment of the invention is a device for removal of non-living material from skin of a subject, the device comprising a layer of a pressure sensitive adhesive applied to a support substrate, the pressure sensitive adhesive having a cationic polymer and a plasticizing agent. The cationic polymer can be an amino acrylate polymer, for example, an amino acrylate polymer selected from the group consisting of a copolymer of an amino methacrylate; a copolymer of an octylacrylamide, an acrylate, and an amino methacrylate; and a copolymer of a vinylpyrrolidone and a dimethylaminoethyl methacrylate. In one embodiment, the amino acrylate polymer is a copolymer of an amino methacrylate. Alternatively, the cationic polymer can be an amino silicone or an amino cationic cellulosic polymer.

An exemplary polymer is the copolymer poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1, for example, the commercially available copolymer EUDRAGIT^® E 100, as described in A. J. Shukla, Polymethacrylates. in "Handbook of Pharmaceutical Excipients," 2nd Ed., A Wade and P.J. Weller, editors, pp. 362-366, 1994. See also, Provisional Technical Data Sheet. "Pressure-sensitive adhesive matrix based on EUDRAGIT^® E 100 for manufacturing of transdermal therapy systems, " Rohm GmbH, Darmstadt; Hiils America Inc., Somerset, NJ. These references are hereby incorporated herein by reference. Other commercially available amino functional polymethacrylates include: poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride), 1:2:0.2, for example, the commercially available copolymer EUDRAGIT^® RL 100, and poly( ethyl acrylate, methyl methacrylate, trimethyolammonioethyl methacrylate chloride), 1:2:0.1, for example, the commercially available copolymer EUDRAGIT^® RS 100. Other cationic copolymers can be used in embodiments of the invention, for example, a copolymer of octylacrylamide, an acrylate, and an amino methacrylate such as Amphomer^®, Versaty^® 42, or Lovocryl^® 47, supplied by National Starch and Chemical Company, Bridgewater, NJ; a copolymer of vinylpyrrolidone and dimethylaminoethyl methacrylate such as GAFQUAT^®734 or GAFQUAT^® HS-100, supplied by ISP, Corp., Wayne, NJ; or an amino silicone polymer such as polydimethylsiloxypropyl polyethoxyl acetyl cocamidopropyldimethyl ammonium chloride (commercially available, for example, as PECOSIL^® CA-1240, supplied by Phoenix Chemical, Inc., Somerville, NJ); or a cationic amino cellulosic polymer such as CELQUAT^® H-100, CELQUAT^® L-200, CELQUAT^® SC-240C, or CELQUAT^® SC-230M, supplied by National Starch and Chemical Company, Bridgewater, NJ. Examples of plasticizing agents include: a citrate ester such as triethyl citrate (TEC), acetyl triethyl citrate (ATEC), tributyl citrate (TBC), acetyl tributyl citrate (ATBC), and acetyltrihexyl citrate, supplied by Morflex, Inc., Greensboro, NC; a glycol such as ethylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, propylene glycol, dipropylene glycol, tripropylene glycol, butylene glycol, a polyethylene glycol, a glycol ether, sorbitol, and glycerol or a glycerol derivative; triethanolamine (trolamine), triacetin, a phospholipid or a low molecular weight excipients used in cosmetic or pharmaceutical formulations such as ethyl alcohol, methyl propanediol, and vegetable oil; a phthalate ester such as butyl benzyl phthalate, dimethyl phthalate, dibutyl phthalate, dioctyl phthalate, and diethyl phthalate; an adipate plasticizer such as dibutyl adipate and dioctyl adipate; and a phosphate plasticizer such as 2-ethylhexyl diphenyl phosphate; a mineral oil; and a polymeric plasticizing agent such a polybutene, a polyisobutylene, a vinyl ether polymer or a copolymer, and polyethylene imine. In one embodiment, the plasticizing agent is a citrate ester, more preferably, acetyl tributyl citrate (ATBC).

Fabrication of a device having a PSA matrix layer and a support substrate Figure 1 shows cross- sections of embodiments of a device of the invention having a backing support (1), a pressure-sensitive adhesive matrix layer (2) having a pressure-sensitive adhesive cationic polymer, and a release liner (3). The device of the composition can have a release liner layer placed on the pressure-sensitive adhesive matrix composition layer on a surface opposite to that of the backing support. A device can be provided with a tab for convenient removal of a support substrate, formed by providing an area of the substrate, either the support backing or the release liner or both, that has been sheltered from deposition of adhesive matrix. Accordingly, to remove the release liner from the device to expose the adhesive matrix prior to application of the device to the skin, a tab (4) is provided for the user to grasp the release liner, as shown at the top of Figure 1.

Similarly, a tab on the backing support (5) is provided so the device can be grasped by the user for removal of the device from the skin. In an embodiment of the device, a tab is provided on each of the release liner and the backing support, as shown in the middle and bottom drawings of Figure 1. The tab for removal of the release liner can be located at different positions on the margin of the device, as shown in the middle of Figure 1 , or can be located at identical positions of the device, as shown in the bottom portion of Figure 1. Figure 2 shows a device in a "bat" shape suitable for application to the nose, and a device of approximately 75% smaller area for application to the chin or other part of the face. A tab as shown in Figure 2 can be an area present on the margin of the device (6), the area having been sheltered from deposition of the adhesive matrix, for example, an area that is semicircular or of other shape that protrudes from the edge of the device and that can be readily grasped with a finger and thumb of the user. In an embodiment of the devices of the invention with tabs have a matrix adhesive layer (2) comprising a pressure-sensitive adhesive composition of the invention, it is within the present invention to provide other devices, for example having aqueous activated adhesives, or water-soluble adhesive compositions requiring a wetting step as shown in Table 1, with a tab on a backing support, for grasping by the user for removal of the device from the skin.

The pressure-sensitive adhesive matrix which is an embodiment of the present invention is prepared from an organic solution of the components, however processing without solvent can be achieved using a "hot-melt" of the cationic polymer, for example, of poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1 (EUDRAGIT^® E 100). The composition can be applied to a release liner sheet or to a non-porous backing support by a standard coating process, for example, using a rotary doctor blade, slot die, a flat film die, or a laboratory coating unit with integrated dryer, for example, LTSV/LTF, W. Mathis AG, Niederhasli, Zurich, Switzerland CH-8155.

Formulation in an organic solvent, of an embodiment of a device of the invention including a pressure- sensitive adhesive matrix layer having a cationic polymer and a plasticizer as a water-free solution or suspension, can use solvents such as ethanol, methanol, propanol, or other organic solvents, or a mixture of organic solvents. A solution or dispersion of the composition in the solvent can be deposited as a film or matrix layer to a sheet of a release liner, dried to remove the solvent, and then covered by application of a sheet of backing support. Alternatively, the device can be produced as a layer of composition deposited on a backing support if the support is nonporous, then can be dried to remove the solvent.

An embodiment of a device comprises a support substrate, which can be a backing support of a nonwoven, nonocclusive film of high moisture vapor transmission. The backing support can impart tensile strength so that the device can be handled easily, and applied and removed without leaving a portion of the composition or device remaining on the skin. The backing support can be nonporous, microporous, or macroporous, such as a woven or a nonwoven composition, and can be occlusive, semiocclusive or nonocclusive to moisture. The nonwoven material is selected from the group consisting of polyethylene, polyolefin, polyurethane, polyester, polypropylene, nylon, cotton, rayon, polyvinyl chloride and a cellulosic fiber. An embodiment of the device can have a backing that is a nonwoven, nonocclusive polyester or polyolefin film. An embodiment of the device has both a backing support and a release liner. A release liner can be a material selected from the group consisting of paper, polyester, and polystyrene, and can be coated with a silicon or fluorocarbon based release coating. The release liner is removed from the device prior to applying the composition of the matrix layer to skin of a subject having an unwanted keratotic plug. A release liner material can be MediRelease 2226, a polyester silicone release liner obtained from Bertek Medical Products, St. Albans, VT.

A method of fabrication of a device can be by application of a composition to deposit it on the surface of a large sheet of a release liner or a non-porous backing to a desired thickness, drying the matrix layer to the sheet, applying a backing or a release liner to the composition layer, and cutting the sheets in a pattern to produce a device which is an embodiment of the invention. For example, an adhesive-coated release liner can be transfer laminated to a backing, for example a non-woven backing, using a double-roller procedure known to one of ordinary skill in the art of transfer lamination. Deposition of a solution or a suspension of a PSA composition to a support substrate, can be, for example, to a release liner continuously supplied by a doctor roll apparatus, reverse roll, gravure, slot die or other suitable method to coat the adhesive onto the substrate. Alternatively a pressure-sensitive adhesive matrix layer can be formed by deposition onto a backing support. A backing support can be added to a dried pressure-sensitive adhesive matrix layer that has been deposited on a release liner, to form a three-layer device with the pressure-sensitive adhesive matrix layer between the release liner and the backing support. The pressure-sensitive adhesive matrix layer can also be applied to a support substrate by extrusion of a hot melt formulation of the composition. A tab is made by providing an area of the release liner or the backing support lacking adhesive matrix, so that the tab provides a handle for convenient removal of the release liner, and/or removal of the device from the skin of the subject. The pressure-sensitive adhesive matrix layer of the device having the PSA and other ingredients can have a thickness of one to 10 mil, preferably a thickness of 2 to 5 mil, more preferably a thickness of 2.5 mil, even more preferably a thickness of 3.5 mil. The backing support can have a thickness of 0.5 to 10 mil, preferably a thickness of 3 to 5 mil. The release liner can have a thickness of 0.5 to 10 mil, preferably a thickness from 3 to 5 mil. The entire device can have a thickness of 3 to 50 mil, for example, can be 4, 8, 12, 16, 20, or 24 mil thick.

The laminated sheet can be cut into a plurality of devices using a stamp-type cutter, or by rotary die cutting, both techniques known to one of ordinary skill in the art. Embodiments of devices of the invention can be in the shape of rectangles ("strips"), circles, circular sectors, and other regular or irregular shapes such as bat shapes. A device can have an area of from 5 to 100 sq. cm., for example, from 5 to 25 sq. cm., from 5 to 30 sq. cm., from 20 to 50 sq. cm., from 5 to 200 sq. cm., and from 10 to 250 sq. cm. A suitable shape for a device is bat-shaped, for example, of dimension approximately 3 by 8 cm., about 20 to 24 sq cm, for removal of one or more plugs from a particular area of the face such as the bridge and sides of the nose.

A device for application to another area of the skin, for example, to the chin, can have a smaller dimension, for example, 2.8 by 6.5 cm, and have a concomitantly smaller surface area, for example, 12, 15, or 18 sq cm. A tab lacking a pressure- sensitive adhesive matrix layer can extend from the device at one of the longer axes. The user of the device can be directed to cut the strip into smaller shapes for ease of application to an isolated plug in an inaccessible location, such as a plug located in a narrow groove, for example, behind an ear, or in a crease of the nose. Additional ingredients and excipients The cationic polymers of the various embodiments of the invention have a large capacity for containing additional ingredients and excipients as described herein, without loss of advantageous physicochemical properties. Thus, an ingredient beneficial to the skin can be added to the PSA composition of the device, to aid in removal of a pore plug and minimize trauma to the pore and to the surrounding skin upon removal of the device, and to recondition the skin and pores of the subject. Ingredients can be added to the polymer in solution or dispersed in a suspension, or following the hot melt process. Other cationic species that can be used include inorganic and organic cationic compounds such as calcium, zinc, magnesium and the like, with an inorganic or organic negatively charged counterion. Examples of such compounds include zinc oxide, calcium EDTA, calcium stearate, magnesium stearate, and the like. A suitable cationic compound is zinc oxide. Formulation of an embodiment of compositions of the invention in the absence of water allows incorporation of ingredients such as plasticizers, anti-irritants, amino acids, moisturizers, humectants, vitamins, and porolytic agents. These can be more stably maintained in the devices of embodiments of the invention at ambient temperatures in the absence of preservatives, than if the device was formulated in the presence of water. Water-based cosmetic formulations can require addition of preservatives, for example, imidazolidenyl urea, diazolidenyl urea, parabens, quaternium 15, benzyl alcohol, or phenoxyethanol. A preservative is commonly present in skin care products at 0.3 to 0.7% by weight. The embodiments of compositions and devices of the invention herein, formulated in the absence of preservatives, can provide additional excipients for removal of matter such as a pore plug, a keratotic plug, or a microorganism, and for enhanced healing and decreased inflammation of areas of skin. A person with sensitive skin can use such a device, since it can be formulated in the absence of preservatives, which may cause skin irritation and sensitization. The pressure-sensitive adhesive matrix layer having a cationic polymer and a plasticizing agent embodiments of the device of the invention can have the following optional components: a skin anti-irritant, a cleansing agent, an antiseptic, a colorant, a pigment, a filler, an antioxidant, a cationic inorganic salt having an organic or inorganic counterion as described above herein, a cosmetically active ingredient such as a a keratolytic agent, a moisturizer, a humectant, a skin reconditioning agent, a vitamin, a nutritional supplement, and a skin skin penetration enhancer.

Examples of anti-irritants include: α-bisabolol, camomile, tea tree (Melaleuca alternifolia) oil, and green tea (Camellia sinensis) extract, aloe (Aloe vera) extract, licorice (Glycerrhiza glabra) extract, glycyrrhetinic acid, witch hazel (Hamamelis virginiana) extract, and glycerol. Exemplary anti-irritants are α-bisabolol and tea tree oil. Examples of cleansing agents include: polyoxyethylene 20 sorbitan monolaurate, polyoxyethylene 20 sorbitan monopalmitate, polyoxyethylene 20 sorbitan monostearate, and polyoxyethylene 20 sorbitan monooleate (for example, Tween 20, Tween 40, Tween 60, Tween 80, respectively, obtained for example from ICI Surfactants, Wilmington, DE). Examples of antiseptics include: an alcohol such as ethyl alcohol, isopropyl alcohol, phenyl alcohol, and tea tree oil.

Examples of colorants which are insoluble pigments include: titanium dioxide, zinc oxide, silica, and alumina. In one embodiment, the colorant is titanium dioxide, for example titanium dioxide (commercially available as TiO₂ Sperse™GLY; Collaborative Laboratories, East Setauket, NY). A colorant can be a soluble composition, such as an FDC-approved dye, or can be a lake.

Examples of fillers include: a fumed silica such as Cab-O-Sil M-5 supplied by Cabot Corporation (Tuscola, IL); kaolin; a silica gel; a clay; a micro-crystalline wax; a micro-crystalline cellulose; and a polymer used as a pharmaceutical or cosmetic excipients such as polyvinyl pyrrolidone; a polyvinyl formamide; or a acrylic polymer for enteric coatings (e.g. Eastacryl 30D from Eastman Chemical Company: Kingsport, TN); and a cellulose ester such as those available from Eastman Chemical. In an embodiment, the filler is a fumed silica, for example, Cab-O-Sil supplied by Cabot Corporation (Tuscola, IL). Examples of antioxidants are propyl gallate, sodium bisulfite, ascorbic acid

(vitamin C) and ascorbic acid esters, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), vitamin E, and cysteine.

Examples of moisturizers include : a preparation of vegetal ceramides such as Ceramide II (obtained from Quest International, Ashford, Kent, England), hyaluronic acid, an essential fatty acid preparation, a collagen, a lipid, a phospholipid, castor oil, sorbitol, glycerol, a glycol, a glycol derivative, and a glyceride, etc.

Examples of vitamins include: vitamin A, vitamin A palmitate, β-carotene, ascorbic acid (vitamin C), ascorbyl palmitate, tocopherol (vitamin E), tocopheryl acetate (vitamin E acetate), vitamin K, and vitamin F (glyceryl linoleate and glyceryl linolenate).

Examples of skin-conditioning ingredients include: extract of any of aloe (for example, Aloe vera), Camellia sinensis (green tea), camomile, cucumber, corn flower, orange peel, dog rose hip; marine extracts such as those from seaweed, kelp, and algae; rice bran oil, wheat germ oil, avocado oil and almond oil; an α-hydroxy acid such as glycolic acid, lactic acid, malic acid, and citric acid; a β-hydroxyl acid such as salicylic acid, a polymeric hydroxylic acid, and a ketoacid; and a β-glucan, panthenol, an anthocyanidin, a phytic acid, and an amino acid such as glycine, proline, lysine and leucine.

Examples of skin skin penetration enhancers are those commonly used in transdermal drug delivery patches. General chemical classes of skin permeation enhancers are sulfoxides, alcohols, fatty acids, fatty acid esters, polyols, amides, terpenes, alkanones, and organic acids.

The ranges of optional ingredients of the compositions in weight per cent can be: a skin anti-irritant, 0-5.0 weight %; a cleansing agent, 0-10 weight %; an antiseptic, 0-5 weight %; a colorant, 0-5.0 weight %; a filler, 0-30 weight %; an antioxidant, 0-2 weight %; a cationic inorganic salt, 0-20 weight %; a cosmetically active ingredient such as a moisturizer, a skin reconditioning agent, a vitamin, and a nutritional supplement, 0-20 weight % for each; a humectant, 0-10 weight %; a pigment, 0-5 weight %; a keratolytic agent, 0-10 weight %; and a skin skin penetration enhancer, 0- 10 weight %.

In various embodiments, the ranges of ingredients of the compositions in weight per cent can be: the cationic polymer, 30-90%; the plasticizing agent, 5-60%; and optionally, the skin anti-irritant, 0.5-5.0%; the cleansing agent, 1.0-10%; the antiseptic, 0.1-5%; the colorant, 0.1-5.0%; the filler, 5-30%; the antioxidant, 0.5-2%; the cationic inorganic salt, 0.1-20%; the cosmetically active ingredient such as a moisturizer, a skin reconditioning agent, a vitamin, a nutritional supplement, 0.5-20%; and the skin skin penetration enhancer, 0.5-10%.

In embodiments of the pressure-sensitive adhesive matrix layer of a device, the polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1 :2:1, is present at 30-90% by weight; ATBC is present at 5-60% by weight; α-bisabolol is present at 0.5-5.0% by weight; titanium dioxide is present at 0.1- 5.0% by weight; zinc oxide is present at 0.1-5.0% by weight; and polyoxyethylene 20 sorbitan monolaurate is present at 0-10% by weight. In a preferred embodiment of a pressure-sensitive adhesive matrix layer of a device, the polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1:2:1, is present at 30-40% by weight; ATBC is present at 10- 20% by weight; α-bisabolol is present at 0.5-1.0% by weight; titanium dioxide is present at 1.5-2.5% by weight; zinc oxide is present at 0.5-2.0% by weight; and polyoxyethylene 20 sorbitan monolaurate is present at 0.5-3.0% by weight.

In one embodiment of this device, the polymer poly(butyl methacrylate, (2- dimethyl aminoethyl) methacrylate, methyl methacrylate), 1 :2: 1, is present at 36 parts by weight; ATBC is present at 14 parts by weight; α-bisabolol is present at 0.5 parts by weight; titanium dioxide is present at 2 parts by weight; zinc oxide is present at 1.0 parts by weight; and polyoxyethylene 20 sorbitan monolaurate is present at 1.5 parts by weight. These components can be formulated for manufacture with ethanol, for example, at 44 parts by weight.

A formulation of the composition of the pressure-sensitive adhesive matrix layer of the device comprises the following components, in pounds: the polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1 :2:1, 70.5 pounds; ATBC is present at 27.5 pounds; α-bisabolol is present at one pound; titanium dioxide is present as 4.0 pounds of TiOSperse GLY; zinc oxide is present at 2.0 pounds; polyoxyethylene 20 sorbitan monolaurate (Tween 20) is present at 3.0 pounds; and ethanol, 88.4 pounds. In an embodiment of a device, the components of the pressure-sensitive adhesive matrix layer are present in the following ranges of quantities per an area of skin: polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1:2:1, 2-20 mg/sq cm; ATBC is present at 0.5-5 mg/sq cm; α-bisabolol is present at 0.03-0.3 mg/sq cm; titanium dioxide is present at 0.05-0.5 mg/sq cm; zinc oxide is present at 0.05-0.5 mg/sq cm; and polyoxyethylene 20 sorbitan monolaurate is present at 0.05-0.5 mg/sq cm.

In an embodiment of a device, the components of the pressure-sensitive adhesive matrix layer are present in the following quantities per an area of skin: polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate), 1:2:1, is present on an area of skin at a concentration of 6 mg/sq cm; ATBC is present at 2.3 mg/sq cm; α-bisabolol is present at 0.08 mg/sq cm; titanium dioxide is present at 0.3 mg/sq cm; zinc oxide is present at 0.05-0.3 mg/sq cm; and polyoxyethylene 20 sorbitan monolaurate is present at 0.25 mg/sq cm.

Additional uses of embodiments of the invention

In one embodiment, the invention features a method for removing non-living matter, for example, a keratotic plug, from skin of a subject, having steps of: applying a composition of the invention to the skin, allowing the composition to bond to the nonliving matter; and removing the composition from the skin. Non-living matter can include dead skin cells, cell debris, sebum, soot, dirt, particulates, pore plugs, keratotic pore plugs, residues of paniculate cosmetics, and food particles.

Another embodiment of the invention is a method for removing living matter, for example, microorganisms such as bacteria, fungi including yeasts and molds, and virus particles, or cells of higher organisms such as pollen granules, from skin of a subject. In a further embodiment, there is provided a device for removing living material from skin of a subject, the device comprising a pressure sensitive adhesive layer applied to a support substrate, the pressure sensitive adhesive having a cationic polymer and a plasticizing agent. The living material is a cell of a microorganism selected from the group consisting of a bacterium, for example, a cell of Propionibacterium acnes, Staphylococcus aureus, Streptococcus epidermis, Escherichia coli, or Shigella dysenteriae; a fungus, for example, Lichen planus, or Candida alhicans; and a virus, for example, a herpes virus such as HSV type I or a retrovirus such as feline leukemia virus; or the living material can be from a higher organism, for example, the living material can be pollen.

In a related embodiment, a device for removing living material from skin of a subject can be a diagnostic device, wherein the cell of the microorganism can be detected and identified by standard diagnostic means. In an embodiment of a diagnostic device, a diagnostic composition can be formulated as a part of or impregnated into the matrix adhesive layer of the device. The device can include a reagent that is specific for binding to some chemical entity associated with one or more of the microorganisms to be removed and detected.

In an embodiment of the invention that is a method having a step of removing a composition from the skin, a step is provided of detecting and identifying a microorganism bonded to the composition. The microorganism can be identified by a method of determining the identity of a species or strain of a microorganism, the method known to one of ordinary skill in the art, for example, use of an antibody specific to an antigen of the microorganism, for example, an antibody conjugated to a dye, such as a fluorescent dye, such as fluorescein isothiocyanate, or an antibody bound to an enzyme, for example, horseradish peroxidase, or a nucleic acid probe of base sequence specific to the microorganism. Identification can be achieved by nucleic acid hybridization using each of a series of probes selected as having sequences that are specific to each of the species or strains of microorganism to be identified. The probes can comprise naturally occurring nucleic acids, or example, DNA or RNA, or can contain nucleotide homologs, or can be labeled with a radioisotope or a fluorescent dye.

A method of use for cleansing the skin by removing a keratotic plug from a subject involves: removing a release liner from the composition layer; applying the device to the skin with a pressure-sensitive adhesive composition in contact with the skin; pressing the device with gentle pressure to contact the skin for an effective time period, for example, from 1 to 30 minutes; and removing the device from the skin. An effective period of time can be, for example, from 1 to 30 min., preferably from 5 to 15 min., and more preferably from 5 to 10 min. The effectiveness is determined by removal of a keratotic plug from the skin, and by extent of exfoliation and extent of removal of matter from the skin. An embodiment which is a method of use of a pore plug removal device of the invention can be: removing the release liner from the device; applying the composition to an area of skin such that the pressure-sensitive adhesive matrix layer, attached to its backing, contacts the skin for a period of time, for example, of up to 30 min.; and removing the device so that pore plugs and other non-living or living matter adhere to the pressure-sensitive adhesive matrix layer and are removed from the skin. It is within the scope of the present invention to provide a composition formulated for use as a poultice. Examples The Examples show formulations and results obtained from experiments that tested variables such as the particular cationic polymer PSA composition, the plasticizer composition, the addition of a colorant, the presence and composition of a moisturizer, and the thickness of the matrix adhesive layer of the device.

Examples 1 , 2 and 3 show devices with a PSA composition having the cationic polymer poly utyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1, and the plasticizing agent ATBC. The composition was formulated into a device having a release liner, a pressure-sensitive adhesive matrix layer, and a support backing. In Example 1, the thickness of the pressure-sensitive adhesive matrix layer was 2.5 mil, and in Example 2, the thickness was 3.5 mil. In Example 3, zinc oxide, 2g, was added to the formulation used in Example 2.

Examples 4 and 5 show devices with PSA compositions having different PSA compositions, with a PSA and plasticizer combination other than the combination of poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate. methyl methacrylate) 1:2:1 with ATBC. The PSA of the device of Example 4 was the thermoplastic acrylic copolymer adhesive MA31, and that of Example 5 was Durotak 87-2287.

Example 6 tested a commercially available product, Pond's^® Clear Pore Strips, for the purposes of comparison to the devices with PSA compositions that are embodiments of the present invention. The performance test data collected from use of each of the devices described in Examples 1 to 6 are compared in Table 4.

Examples 7 through 11 describe additional embodiments of devices having PSA composition embodiments of the present invention. Examples 7 through 10 used devices having the cationic polymer poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1 :2:1. Further, in the device of

Example 7, the PSA composition included two plasticizing agents, trolamine (10 parts by weight) and ATBC (17.5 parts by weight). In Example 8, a preparation of vegetal ceramides, 0.4 parts by weight, was present. In Example 9, the plasticizing agent TEC was used, and ATBC was omitted. In Example 10, the moisturizer phospholipid GLA, 10 parts by weight, was present, and ATBC content was reduced to 22.5 parts by weight compared to the ATBC content in the formulation of devices of the previous Examples. The formulations for the devices of Examples 7-10 and the results of the performance tests for devices having these formulations are shown in Table 5.

Example 11 describes a device having a PSA composition with the cationic polymer GAFQUAT^® 734 rather than poly utyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1, and having glycerol as the sole plasticizing agent.

Example 12 describes a comparison test of a device of the present invention having the formulation of Example 3 above, with a commercially available product that requires pre-wetting, for the attributes of ease of application and removal, pain/discomfort, and overall rating. Fabricating procedures

The composition was prepared as a solution or dispersion by dissolving or dispersing the ingredients in a liquid carrier vehicle such as an organic solvent or blend of solvents (for example, ethanol, acetone, etc.) or water. The solution or dispersion was then coated on a polyester release liner which was then dried to remove the carrier solvent. After the coating was dried, the pressure-sensitive adhesive matrix composition with the release liner was transferred to a backing support, such as a nonwoven material composition. The finished product thus had a construction of three layers: a protective release liner, a dried PSA matrix layer, and a backing support. In the examples below, the PSA matrix layer had a thickness of 2.5 mil unless otherwise indicated. The three-layer sheet was die-cut into 1.5 in x 3 in strips for use on an area of skin such as on the nose, chin, forehead, and cheek. Performance test for efficacy

Six human subjects were used for the evaluations. Subjects were pre-screened to obtain those with skin having a minimal threshold of keratotic plugs on the nose area. The objective of the test was to determine the number of keratotic plugs removed by each device of the Examples from the nose area of a subject. The subject first washed with warm water areas of skin where the strip device was to be applied, such as the nose and the surrounding skin, and then dried the area thoroughly with paper towels. A release liner was removed from a strip device embodiment of the invention, and the side of the device having the PSA matrix layer was manually applied to the skin of the nose, such that the PSA layer side of the device formed an even contact with the area of skin. In each of the performance tests shown in the Examples below, the strip was left in contact with the skin of the nose for 5 minutes, and then the strip with adhering plugs was removed. Keratotic plugs adhering to the strips were counted under a magnifier, and the numbers for each Example were recorded. Example 1. A device having poly utyl methacrylate, (2-dimethyl aminoethyl jmethacrylate, methyl methacrylate) 1:2:1 copolymer and ATBC plasticizer PSA composition

The ingredients listed in Table 2 were mixed in the proportions indicated, and agitated until homogeneous. The solution was coated on a polyester release liner and the device was dried in an oven at 80°C for 15 min to remove the solvent. Analysis by gas chromatography showed that the residual solvent remaining in the dried PSA was less than 5,000 ppm. The dried coating thickness of the pressure-sensitive adhesive matrix layer was 2.5 mil (2.5 x 10^~3 inches). The dried PSA layer coating the release liner was transferred to a nonwoven material backing support, to make a three-layer laminate device having a nonwoven backing, a PSA matrix layer of the indicated composition, and a release liner. The laminate was die cut into 1.5 in by 3 in devices (strips), which were used to carry out the performance test above to determine efficacy of removal of keratotic plugs.

The result of the performance test was that 45 plugs were removed from the skin using the device of Example 1.

Example 2. Varying the thickness of the pressure-sensitive adhesive matrix layer

The same composition and procedure of Example 1 was coated on a polyester release liner to yield a dried coating thickness of the PSA matrix layer of 3.5 mil, and transfer laminated to a nonwoven backing. The performance test described above was carried out for the device strips of Example 2, and results are shown in Table 4.

The result of the performance test was that 100 plugs were removed from the skin using the device of Example 2, more than twice that observed in Example 1. Example 3. Addition of zinc oxide to the formulation

To the composition of Table 2 was added 2g of zinc oxide, USP grade, the dried PSA matrix layer was coated to a thickness of 3.5 mil, and finished devices were prepared as in Example 2. Results of the performance test are shown in Table 4. The result of the performance test was that 104 plugs were removed from the skin using the device of Example 3. The presence of zinc oxide in the formulation did not affect the efficiency of the PSA composition for removal of plugs. Example 4. Use of acrylic adhesive MA31

A composition was fabricated by the same procedure as in Example 1 , using the commercial pressure-sensitive acrylic adhesive, MA31, supplied by Adhesive Research Inc., (Glen Rock, PA) to replace both the cationic polymer poly(butyl methacrylate, (2- dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2: 1 and the plasticizer ATBC. The composition is shown in Table 3, and the efficacy data from the performance test in Table 4.

Table 2. Composition of Examples 1 and 2

ingredient relative proportion bv weight

EUDRAGIT^® E 100 72.5

ATBC 27.5 α-bisabolol 1

Tween 20 3 titanium dioxide Sperse™ GLY 4 ethanol, as solvent 100

EUDRAGIT^® E 100 is poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1; and TiO₂ Sperse™ GLY is a dispersion of 30% titanium dioxide and 1.9% alumina in 63.8% glycerin, obtained from Collaborative Laboratories.

The result of the performance test was that only 1 plug was removed from the skin using the device of Example 4. Thus this formulation is much less efficient that those using the cationic polymer poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1 and the plasticizer ATBC. Example 5. Use of pressure-sensitive acrylic adhesive Durotak 87-2287

A composition was fabricated by the same procedure as in Example 1 , using the commercial pressure-sensitive acrylic adhesive, Durotak 87-2287, supplied by National Starch and Chemical Company (Bridgewater, NJ), in place of both the cationic polymer poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1 and the plasticizer ATBC. The composition is shown in Table 3, and the efficacy data from the performance test in Table 4.

The result of the performance test was that 0 (zero) plugs were removed from the skin

Table 3. Compositions Having Commercial Pressure-sensitive Adhesives

example ingredient relative proportion bv weight

4 MA31 260 α-bisabolol 1

Tween 20 3

TiO₂ Sperse™ GLY 4

5 Durotak 87-2287 196 α-bisabolol 1

Tween 20 3

TiO₂ Sperse™ GLY 4

Table 4. Results of Performance Test, Examples 1 through 5

plugs from nose device adhering to device water requirement Example 1 45 No Example 2 100 No Example 3 104 No Example 4 1 No Example 5 0 No Example 6 20 Yes

using the device of Example 5. Thus, this adhesive as formulated here was observed to be not suitable for removal of plugs from pores. Example 6. Control device for comparison to device embodiments of the invention

Pond's^® Clear Pore Strips, a commercial product for removal of keratotic plugs, was purchased from a local drugstore, and the plug removal test was performed as described above, except that the product was applied to the skin and used as recommended by the instructions provided. Thus the product was moistened, and placed in contact with the skin for 15 min as required for the moisture-activated adhesive to dry. Thus an additional step was required for the method of use of the commercial product, in comparison to the embodiment method of the present invention described above: while wetting the strip with water before applying it to the nose is not required. (Alternately, an additional step for use of the commercial product can involve wetting the nose with water and applying the Pond's^® Clear Pore Strips and the devices listed in Table 1 to the moist skin site.)

The result of the performance test with the Pond's^® Clear Pore Strips was that 20 plugs were removed from the skin. Thus Pond's^® Clear Pore Strips is less efficient than those devices of the present invention with the PSA matrix layer compositions described in Examples 1-3 and 7-11 herein.

The data in Table 4 show that a device which is an embodiment of the present invention with the PSA composition having the combination of poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2: 1 and ATBC, as in Examples 1 and 2, was superior in performance for removing pore plugs from skin, compared to devices having the other compositions tested in Examples 1-6. Between one and two orders of magnitude more pore plugs adhered to the devices having the composition of Example 1 and Example 2, than to those having either of two commercial pressure-sensitive acrylic adhesives (Examples 4 and 5). The devices that are embodiments of the invention removed two to five-fold more pore plugs than a commercially available product, Pond's^® Clear Pore Strips, tested in Example 6. Further, the devices having the combination of poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1 and ATBC, an embodiment of a PSA composition of the invention comprising a cationic polymer and a plasticizing agent, did not require an additional step of wetting the skin or the device, prior to application of the device. Examples 7. 8. 9. and 10. Efficacy for keratotic plug removal of compositions having different plasticizer formulations, or having an added moisturizer composition

Table 5 provides formulations for Examples 7, 8, 9 and 10 with devices having additional PSA compositions of the embodiments of the present invention. Each of these formulations contained the cationic polymer poly(butyl methacrylate, (2- dimethyl aminoethyl) methacrylate, methyl methacrylate) 1:2:1. The data also in Table 5 indicate performance of these compositions for keratotic plug removal.

Table 5. Examples 7 to 10 Compositions, and Results for Keratotic Plug Removal Efficacy relative proportion bv weight ingredient Example 7 Example 8 Example 9 Example 10

EUDRAGIT^® E 100 72.5 72.5 72.5 72.5

ATBC 17.5 27.5 22.5

TEC 27.5 trolamine 10 α-bisabolol 1 1 1 1

Tween 20 3 3 3 3

TiO₂ Sperse™ 4 4 4 4 vegetal ceramides 0.4 phospholipid GLA 10

results keratotic plugs removed 36 32 30 35

EUDRAGIT^® E 100 is poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1. Phospholipid GLA is a phospholipid complex supplied by Mona Industries, Inc., Paterson, NJ. Vegetal ceramides (Labiomix™) supplied by Lavipharm Laboratoires, Paris, France.

The data show that the devices having the cationic polymer poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate) 1:2:1 formulated in combination with plasticizer trolamine, or with an ATBC and TEC combination, also have ability to remove keratotic plugs with good efficiency, superior to that of the commercial product control of Example 6. The data in Table 5 show that when the device of Example 7 was used, 36 plugs were removed, similar to the 45 plugs that were removed by the device of Example 1 (Table 4). The plasticizer combination of ATBC and trolamine in the device of Example 7 was similarly efficient to an equivalent weight formulation of ATBC alone, in causing removal of pore plugs from skin. Further, the data of Table 5 show that addition of a preparation of vegetal ceramides (0.4 parts by weight) as moisturizer does not significantly affect efficiency of pore plug removal, since the yield of 32 pore plugs removed by the device of Example 8 was comparable if somewhat less than the 45 pore plugs removed by the device of Example 1 (Table 4). The device having the formulation with the plasticizer TEC (Example 9) removed

30 pore plugs. A phospholipid moisturizer used at 10 parts by weight in Example 10, formulated with a plasticizer ATBC at 22.5 parts, did not significantly affect efficiency of pore plug removal. These compositions of a cationic polymer and a plasticizer were more efficient in removal of keratotic pore plugs than the commercial product used in Example 6.

Example 11. Composition for keratotic plug removal having a cationic copolymer of vinylpyrrolidone and dimethylaminoethyl methacrylate, GAFQUAT^® 734

To test an embodiment of the compositions of the invention having a cationic polymer different than the cationic polymer poly utyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate) 1 :2: 1 , for example, a copolymer of vinylpyrrolidone and dimethylaminoethyl methacrylate, the ingredients listed in Table 6 were mixed, fabricated into the strips by the method described above, and tested for efficacy. The performance test described above was carried out on the composition of Table 6. Results of the performance test showed that the strips made with this composition removed 21 keratotic plugs. Thus, the copolymer of vinylpyrrolidone and dimethylaminoethyl methacrylate in the device here (GAFQUAT^® 734) is as effective as the commercially available product shown in Example 6 above and in Table 4, which removed 20 pore plugs. The devices of the present invention, unlike the Pond's^® Clear Pore Strips and the other commercial products listed in Table 1, offer the advantages of requiring no prewetting for use, and being free of preservatives. Table 6. A Composition for Removal of Keratotic Plugs Having Vinylpyrrolidone and Dimethylaminoethyl Methacrylate (GAFQUAT^® 734) ingredient relative proportion bv weight GAFQUAT^® 734 80 glycerol 20

Carbowax^® PEG 400 10 α-bisabolol 1

Tween 20 3 titanium dioxide (Sperse™ GLY) 5

Carboxwax^® PEG 400 is a polyethylene glycol supplied by Union Carbide Chemicals and Plastics Company, Inc., Danbury, CT.

Example 11 illustrates that a device which is an embodiment of the invention having the vinylpyrrolidone and dimethylaminoethyl methacrylate (GAFQUAT^® 734) cationic polymer, as well as a device which is an embodiment of the invention having the cationic polymer poly(butyl methacrylate, (2-dimethyl aminoethyl) methacrylate, methyl methacrylate) 1 :2:1, in combination with a suitable plasticizer as described above, was also effective for removal of keratotic plugs.

Example 12. Comparison test of Example 3 device and commercial product using human volunteer subjects

Twenty-four subjects were tested by using an embodiment of the invention and a commercially available product, Biore Pore Perfect™, each subject using the embodiment of the invention or the commercial product on alternative successive visits. To eliminate a possible differential effects of the primary compared to the later consumer product experience, half of the subjects were given the product having the formulation of Example 3 supra to use on the first visit, and half were given the commercial product requiring pre-wetting (Biore, Table 1 supra). Each subject was given the other of the two products on the subsequent visit, and were asked to rate each product on the attributes of ease of application, ease of removal, pain and discomfort, and overall rating (Table 7).

The data in Table 7 show that subjects consider the formulation of Example 3, as similar to the commercial product on the attributes tested here for ease of application and removal, level of pain or discomfort, and overall rating. The Example 3 formulation comprises poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl

Table 7. Human Volunteer Subjects' Rating of Attributes of the Invention attribute tested Example 3 device Biore device ease of application 4.00 ± 3.18 3.25 ± 2.66

(l=easy to 10=very difficult)

ease of removal 2.96 ± 1.85 2.75 ± 2.01

(l=easy to 10=very difficult)

pain/discomfort 2.83 ± 1.81 3.08 ± 2.36 ( 1 =no pain to 10=very painful)

overall rating 5.87 ± 2.24 6.58 ± 2.55

(l=no good to 10=perfect)

The number before and after the ± sign indicates mean and standard deviation respectively.

methacrylate) 1:2:1 copolymer, ATBC plasticizer, zinc oxide, α-bisobolol, titanium dioxide, and Tween 20. These results illustrate that composition and method embodiments of the present invention, which Table 4 above shows to have significant effect in removing keratotic plugs from skin of the nose, are as acceptable to human subjects as a commercial product having the additional inconvenience of requiring pre- wetting for use.

Claims

What is claimed is:

1. A device for removal of non-living material from skin of a subject, the device comprising: a support substrate; and a layer of a pressure-sensitive adhesive deposited on the support substrate, the pressure-sensitive adhesive including a cationic polymer and a plasticizing agent.

2. A device according to claim 1 , wherein the cationic polymer is an amino acrylate polymer.

3. A device according to claim 2, wherein the amino acrylate polymer is selected from the group consisting of a copolymer of an amino methacrylate; a copolymer of an octylacrylamide, an acrylate, and an amino methacrylate; and a copolymer of a vinylpyrrolidone and a dimethylaminoethyl methacrylate.

4. A device according to claim 3, wherein the amino methacrylate copolymer is selected from the group consisting of poly(butyl methacrylate, (2- dimethyl aminoethyl) methacrylate, methyl methacrylate), 1:2:1; poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride), 1:2:0.2; and poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride), 1:2:0.1.

5. A device according to claim 4, wherein the cationic polymer is poly(butyl methacrylate, (2-dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1.

6. A device according to claim 5, wherein the plasticizing agent is selected from the group consisting of a citrate ester, a sebacate, a glycol, an adipate, a phthalate, a phosphate, a mineral oil, a polymeric tackifying agent, trolamine, triacetin, and a phospholipid.

7. A device according to claim 6, wherein the citrate ester is selected from the group consisting of triethyl citrate (TEC), acetyl triethyl citrate (ATEC), acetyl trihexyl citrate (ATHC), tributyl citrate (TBC), and acetyl tributyl citrate (ATBC).

8. A device according to claim 6, wherein the sebacate is selected from the group consisting of dibutyl sebacate and diethyl sebacate.

9. A device according to claim 7, wherein the plasticizing agent is ATBC.

10. A device according to claim 5, comprising additionally one or more agents selected from the group consisting of an anti-irritant, a cleansing agent, an antiseptic, a colorant, a filler, an antioxidant, a skin protectant, a humectant, a moisturizer, a porolytic agent, a skin reconditioning agent, a cationic salt, a vitamin, a nutritional supplement, and a skin penetration enhancer.

11. A device according to claim 10, comprising an anti-irritant, a cleansing agent, and a colorant.

12. A device according to claim 11, wherein the anti -irritant is selected from the group consisting of α -bisabolol, glycerol, glycyrrhetinic acid, tea tree oil, camomile, Aloe vera extract and green tea extract.

13. A device according to claim 12, wherein the colorant is selected from the group consisting of titanium dioxide, zinc oxide, silica and alumina.

14. A device according to claim 13, wherein the anti -irritant is α-bisabolol, the cleansing agent is polyoxyethylene 20 sorbitan monolaurate, and the colorant is titanium dioxide.

15. A device according to claim 14, wherein poly(butyl methacrylate, (2- dimethyl aminoethyl)methacrylate, methyl methacrylate), 1:2:1, is present at 40-90% by weight; ATBC is present at 5-60% by weight; α-bisabolol is present at 0.5-5.0% by weight; and titanium dioxide is present at 0.1-5.0% by weight.

16. A device according to claim 15, wherein the support substrate is a backing support of a nonwoven, nonocclusive film of high moisture vapor transmission selected from the group consisting of an acrylic, a polyethylene, a polyolefin, a polyurethane, a polyester, a polyethylene, a polypropylene, a nylon, a cotton, a rayon, a polyvinyl chloride, a silicate fiber glass, and a cellulosic fiber.

17. A device according to claim 15, wherein the support substrate is a release liner of a material selected from the group consisting of paper, polyester, and polystyrene.

18. A device according to claim 15, having a water content of less than one percent by weight.

19. A device for removal of living material from skin of a subject, the device comprising: a support substrate; and a pressure-sensitive adhesive layer deposited on the support substrate, the pressure-sensitive adhesive including a cationic polymer and a plasticizing agent.

20. A device according to claim 19, wherein the living material is a microorganism selected from the group consisting of a bacterium, a fungus, and a virus.

21. A device according to claim 20, further comprising a microorganism- targeted reagent.

22. A device for removal of matter from skin of the subject, comprising: a backing support; and an adhesive matrix deposited on the backing support, wherein the backing support is provided with a tab without adhesive matrix, for removal of the device from the skin of the subject.

23. A device according to claim 22, further comprising: a release liner, wherein the release liner is provided with a tab without adhesive matrix, for removal of the release liner from the matrix adhesive layer prior to application of the device to the skin of the subject.

24. A method for removing non-living material from skin of a subject, comprising: (a) applying to the skin a pressure-sensitive adhesive composition having a cationic polymer and a plasticizing agent;

(b) allowing the mixture to bond to the skin and the non-living material; and

(c) removing the composition from the skin.

25. A method according to claim 24, wherein applying a pressure- sensitive adhesive includes providing a backing support for the adhesive composition, the backing support having a tab including an area of the support which has been sheltered from deposition of pressure-sensitive adhesive composition, wherein removing the composition includes grasping the tab.

26. A method according to claim 24, wherein prior to applying to the skin the composition, removing a release liner from the composition includes grasping a tab comprising an area of release liner which has been sheltered from deposition of the pressure-sensitive adhesive.

27. A method for removing living material from skin of a subject, comprising:

(a) applying to the skin a pressure-sensitive adhesive composition having a cationic polymer and a plasticizing agent;

(b) allowing the mixture to bond to the skin and the living material; and (c) removing from the skin the composition, with the living material bonded thereto.

28. A method according to claim 27, further comprising detecting and identifying the living material bonded to the composition.

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