JPH046375B2 - - Google Patents

Description

Claim 1: A composition consisting essentially of (a) a continuous, microporous, hydrophobic polymer film and (b) a high molecular weight component that coats the majority of its surface and resists migration into the pores of the microporous film. a layer of pressure-sensitive adhesive, the adhesive layer being sufficiently thick and continuous to hold the microporous film in close proximity to the opening of the sebaceous gland, and the adhesive layer being sufficiently thick and continuous to hold the microporous film in close proximity to the opening of the sebaceous gland; The microporous film is thin enough that substantially all of the sebum secreted by the sebaceous glands passes through it and enters the pores of the microporous film; The film has a pore volume of approximately 0.01 mm to approximately 0.05 mm.
mm, the pores of the film have an average effective diameter of less than about 0.1 micron, and microporous films are opaque or opalescent to light when the pores are filled with gaseous substances, and when the pores are filled with sebum or other hydrophobic substances. A device for collecting sebum secreted from a subject's sebaceous glands, the device being substantially translucent when filled with a substance.

2 Microporous film has approximately 40% pore volume and approximately 0.01mm
2. The apparatus of claim 1, wherein the film thickness is ˜about 0.03 mm.

3. The device of claim 1, wherein the film is microporous polypropylene.

4. The device of claim 1, wherein the film is a nonwoven material made of fibers selected from the group consisting of polyester, polyether, and polyolefin fibers.

5 The adhesive is made of acrylic acid and methacrylic acid.
selected from the group consisting of homopolymers and heteropolymers of monomers selected from _C2 to _C10 aliphatic esters, _C2 to _C10 aliphatic vinyl ethers and esters, acrylamides and urethanes; 4. The device of claim 3 consisting essentially of a high molecular weight polymer.

6. The device of claim 5, wherein the heteropolymer is a terpolymer of 2-ethylhexyl acrylate, vinyl acetate and t-butylacrylamide.

7 (a) A synthetic pressure-sensitive material consisting essentially of () a continuous, microporous, hydrophobic polymeric film and () a high molecular weight component that coats the majority of its surface and resists migration into the pores of the microporous film. a layer of adhesive, the adhesive layer being sufficiently thick and continuous to hold the microporous film in close proximity to the opening of the sebaceous gland, and the adhesive layer being sufficiently thick and continuous to hold the microporous film in close proximity to the opening of the sebaceous gland; The microporous film is thin enough that substantially all of the sebum secreted by the sebaceous glands passes through it and enters the pores of the microporous film;
% pore volume, and the film thickness is approximately 0.01mm~
Approximately 0.05 mm, the pores of the film have an average effective diameter of less than approximately 0.1 micron, and the microporous film is opaque or opalescent to light when the pores are filled with gaseous substances, and when the pores are filled with sebum or other (b) applying a device comprising a device that is substantially translucent when filled with a hydrophobic substance to the skin of the subject for a predetermined period of time; and (b) removing the device after the predetermined period of time. How to measure the location and approximate rate of sebum secretion.

8. The method of claim 7 further comprising: (c) observing the location, number, and size of the translucent regions of the device.

9 Furthermore, the number and size of the translucent regions of the device,
8. The method of claim 7, comprising comparing with a preselected standard.

10. The method of claim 7, further comprising collecting sebum from the device and measuring the amount of sebum collected.

11 Claim 7 further comprising collecting sebum from the device and measuring the composition of the collected sebum.
Section method.

12. The method of claim 7, wherein the predetermined period of time is in the range of about 20 minutes to about 3 hours.

13. The method of claim 12, wherein the predetermined time ranges from about 30 minutes to about 90 minutes.

14. The method of claim 12, wherein the predetermined time period is at least about 30 minutes.

15 Synthetic pressure-sensitive adhesives consisting essentially of (a) a continuous, microporous, hydrophobic polymeric film and (b) a high molecular weight component that coats most of its surface and resists migration into the pores of the microporous film. a layer of adhesive, the adhesive layer being sufficiently thick and continuous to hold the microporous film in close proximity to the orifice of the sebaceous gland, and the adhesive layer being in contact with the sebaceous gland. The microporous film is thin enough that substantially all of the sebum secreted by the sebaceous glands passes through it and enters the pores of the microporous film, which has a pore volume of about 25% to about 50%. The film thickness is approximately 0.01mm to approximately 0.05mm.
mm, the pores of the film have an average effective diameter of less than about 0.1 micron, and microporous films are opaque or opalescent to light when the pores are filled with gaseous substances, and when the pores are filled with sebum or other hydrophobic substances. A method for removing excess skin from a subject's sebum, comprising periodically and sequentially applying to the subject's skin a device that is substantially translucent when filled with a substance and then removing it. .

TECHNICAL FIELD This invention relates to means for monitoring the location of sebaceous glands and the relative rate of secretions.
More specifically, the invention involves the use of microporous films to ascertain the degree of sebaceous gland activity at a given skin site. According to a preferred embodiment, the invention relates to an adhesive film that can be applied to the skin for the absorption of sebum. After removal, the film contains a surface pattern that can be compared to a standard to determine the relative rate of sebaceous gland location and secretion in the subject's skin. The analytical values obtained are generally the most useful for diagnosing acne as well as oily skin. According to another aspect, the adhesive film can be used therapeutically to reduce the level of sebum in a subject's skin to a desired value, as well as to deliver active agents directly to overproducing or underproducing sebaceous glands. .

(Technical background) Acne vulgaris is a skin disease that is prevalent among adolescents. This acne most commonly appears on the patient's face and torso. The basic lesions of acne are pilosebaceous comedones (or "pimples"). In moderate cases, there may be only a few comedones;
In severe cases, severe, stubborn, and numerous comedones are present. Severe acne can cause permanent scars.

Acne occurs when the skin becomes filled with vesicles containing a rather hard keratinous substance. The collection of these substances is whiteheads and blackheads. When bacteria develop in this keratinous material impaction, the vesicles break down and the inflammatory phase of the disease begins, taking the form of pustules, papules, cysts, and nodules.

Various theories regarding the causes, prevention, and treatment of acne have existed for quite some time. Dr. F. Lyons
At the 1982 annual meeting of the European Society for Skin Research, he presented the results of a study showing a direct relationship between excess sebum secretion and acne. This is likely to provide important information for the monitoring and management of acne, and a great impetus for the study of sebaceous gland secretion patterns.

To date, several methods have been used to collect and quantify secretions from sebaceous glands. One such method is to cleanse the test area of the skin surface with a suitable lipid solvent. Another method involves applying an absorbent material, such as tobacco paper or cotton, to the skin surface for a specified period of time. The amount of sebum collected is then quantified using well known techniques such as chromatography, solvent extraction and distillation. However, this technique pools sebum production and does not provide information about the relative concentration or production of sebaceous glands across different skin regions. Other recently introduced methods include adsorbing sebum onto frozen glass plates, then electrically
Some measure changes in light scattering.

However, the present invention provides a more satisfactory means of analyzing sebum production at different skin sites, which in one application can immediately provide a simple and extensive assessment of sebaceousness, and in another. Applications include the use of comfortable films that can be kept as permanent records and used for semi-quantitative evaluations without resorting to expensive equipment or complex analyses. This allows for faster diagnosis and more focused treatment. In fact, according to one aspect of the invention, the same type of device used for diagnosis can also be applied to the skin with or without the introduction of active agents, and can also be applied to the skin with or without the introduction of active agents, which are related to the production (or secretion) of the skin by the sebaceous glands. It may be used to treat or prevent outbreaks of acne or other conditions.

U.S. Pat. No. 3,449,080, issued June 10, 1969, describes a diagnostic device for measuring chloride levels in a subject's sweat, which involves immersion in a weak acid or base ion exchange resin. Paper that easily absorbs moisture and a suitable pH value such as phenolphthalene.
Consists of an indicator. This device is applied to the forehead of a subject, such as a child, who is sweating. The color of the device changes as it becomes wet due to the subject's perspiration, and the removed color is compared to a pre-made color comparison chart. In this device there are multiple distinct regions containing different predetermined amounts of halide sensitive reagent. The related equipment is
No. 4,163,039, issued July 31, 1979, the device is designed to have an immersed indicator and is capable of detecting when the concentration of sodium or chloride in the subject's sweat is at least 50 meq. Only the color changes. The device consists of a perforated transparent envelope through which sweat is absorbed.

Although these devices have some similarities to those of this invention, they are not suitable for the purposes of this invention because they are due to color changes due to ionic reactions. This is because the amount of ions that may be present in sebum is essentially irrelevant for the diagnostic purposes of this invention. Moreover, these references demonstrate the existence of the function of the microporous film of the present invention and the fact that when the adhesive coated film of this invention is made, it does not itself migrate into the pores of the microporous film, but it allows the passage of sebum. There is no disclosure or suggestion of the need to provide an adhesive coating that allows sebum to be absorbed through the pores of the film.

(Disclosure of the Invention) According to one aspect of the present invention, a method for determining the relative position of active sebaceous glands in the skin of a subject and semi-quantitatively measuring the relative sebum output of the sebaceous glands over a predetermined period of time is provided. The present invention provides a means for collecting sebum secreted from a person's sebaceous glands, which means consists of a continuous, microporous, hydrophobic polymeric film support that is applied to the skin. The film is coated with a thin layer of synthetic pressure-sensitive adhesive consisting essentially of high molecular weight polymers, and this adhesive layer is finely coated to facilitate the transfer of secreted sebum into the pores of the backing material. thick enough to provide adequate adhesion between the pore support and the subject's skin, and thin enough that a substantial amount of sebum is not prevented from migrating due to its clumps. . The adhesive must also be substantially incapable of migrating itself into the holes in the polymeric film.

According to another aspect, the invention provides a method for mapping the location of sebaceous glands in a subject's skin, particularly on the face, and semi-quantitatively measuring relative sebum production or secretion from the sebaceous glands per unit time. The method comprises applying a continuous, microporous, hydrophobic polymeric film to a subject's sebum for a predetermined period of time, preferably comprising:
After a predetermined period of time, the film is removed from the skin and half of the test sample is It consists of comparing the number and size of transparent areas with those of a preselected standard. Furthermore, if desired, sebum can be recovered from the film, and its amount and composition can be measured by conventional analytical means known in the art.

More specifically, to quickly and generally assess a skin area, apply the film directly to the skin for a few seconds,
Compare with standard. If a more detailed evaluation or a relatively permanent record is desired, the adhesive site of the covering film is applied to the skin for an extended period of time, generally on the order of one hour.

In another embodiment of the invention, the microporous film described above is applied to the skin periodically to remove excess sebum secreted by the skin and treated to adjust skin levels in the subject's skin. used above. In a further specific example, the above-mentioned diagnostic method is first used to confirm the abnormal sebum production site,
A microporous film impregnated with an active agent that regulates sebum secretion from the sebaceous glands in the area is then applied to the area, thereby continuously supplying the sebaceous glands with the sebum secretion regulating agent. It provides a reliable local treatment for selected areas of high (or low) sebum production.

BEST MODE FOR CARRYING OUT THE INVENTION A presently preferred continuous microporous film for use in accordance with this invention is a microporous polypropylene film available from Celanese Fibers Marketing Company under the trade name CELGARD. . A particularly preferred film is Celgard Grade 2400. Other such materials may be substituted, but must have similar required qualities. Continuous and microporous, i.e. hydrophobic in nature (sweat absorption would interfere with sebaceous gland distribution and sebum secretion being visible) and with the ability to freely absorb lipids such as skin. It needs to be a sexual material. Suitable examples include nonwoven materials such as polyurethane impregnated nonwoven pulp sheets made of fibers selected from the group consisting of polyester, polyether and polyolefin fibers.

In addition to the above qualities, a suitable film should be such that the film becomes opaque or milky when the pores of the film are filled with air or other gaseous substances, and becomes translucent or transparent when it absorbs lipids such as sebum. It should have pores of appropriate size and distribution. For example, about 40% pore volume and about 0.01~
Celgard, a microporous polypropylene film with a thickness of 0.03 mm, has been found to be suitable.
In general, these properties vary from about 25% to about
It is present when the film has a pore volume of 50% and a film thickness of about 0.01 mm to about 0.05 mm. Preferably, the effective pore diameter is less than about 0.1 micron.

While many commercially available pressure-sensitive adhesives can be used to coat microporous films, these adhesives are designed to minimize the possibility of migration into the pores of the microporous film during storage (thereby rendering the film opaque). ),
It is important that it is substantially free of low molecular weight components. Many conventional pressure sensitive adhesives meet this criterion. Preferred adhesives used in the construction of this invention include acrylic acid and methacrylic acid.
There are homopolymers and polymers derived from C ₂ to _{C 10} aliphatic esters, C ₂ to _{C 10} aliphatic vinyl esters, and monomers selected from ethers, acrylamides, urethanes, etc. . (Rubber-based adhesives and other adhesives containing low molecular moieties should be avoided as they tend to migrate into the pores of the film.) 2-Ethylhexyl acrylate, vinyl acetate and t
Terpolymers of -butylacrylamide have been found to be particularly suitable. Almost 60 of the above ingredients:
One suitable terpolymer is present in a 25:15 ratio.

It is understood that the adhesive should be applied to the film in a manner that provides as uniform coverage as possible. The adhesive is preferably applied by well-known transfer techniques to minimize the possibility of adhesive migration into the pores of the film. For example, the terpolymer adhesive described above is first coated in its 45% ethyl acetate solution onto siliconized paper and approximately 80-40 g/g/
The film may be coated to give a dry coverage of ^m2 . Then, add the dried glue to 1.5~
Cold lamination is carried out at a pressure of 2.5MPa (megapascals),
Transfer to microporous film. The silicone paper is then peeled off, leaving the adhesive transferred to the microporous film. If desired, the silicone paper can instead be left as a release paper for convenience during storage. The amount of coverage depends on the adhesive used, for example from about 15 to about 60 g/m ²
can vary widely, from about 15 to about
A coverage of between 30 g/m ² is preferred. As mentioned above, the thickness of the adhesive coat is not so thick as to interfere with the migration of sebum into the pores of the film that overlap with the sebaceous glands, but too thin to provide effective adhesive bonding between the film and the skin surface. It doesn't matter unless it is.

When it is only desired to generally assess the degree of sebaceous gland activity, for example during skin typing for initial clinical evaluation or for selecting appropriate skin care products, such as cosmetics, approximately 5 seconds to about
Apply the microporous film directly to the skin (either uncoated with adhesive or coated with adhesive away from the coating site to be tested) for 60 seconds, preferably at least about 15 seconds, and more preferably about 20-30 seconds. directly applied to. This gives a more translucent surface imprint to areas of greater sebum activity. At the same exposure time, oily skin gives a more translucent film than dry skin. Film specimens obtained in this manner tend to lose their translucency in a relatively short period of time. This is probably because the sheer amount of sebum absorbed is small and tends to spread unevenly into the pores of the film. Therefore, the above method is not suitable for detailed research or for relatively permanent records.

On the other hand, about 20 units of equipment coated with the adhesive of this invention
When applied to a skin site with the adhesive coated side in contact with the skin for a period of from 10 minutes to about 3 hours, preferably at least 80 minutes, more preferably from 60 to 90 minutes, accurate and comparatively permanent results can be obtained regarding the skin activity of the skin site. A detailed record can be obtained. The high accuracy and durability of the samples obtained in this way appear to be due to the fact that a relatively large amount of sebum is absorbed into the pores of the covering film and is held essentially in a suitable manner.

According to another aspect, in order to promote uniformity of results, it is preferred that the skin area be washed with a suitable solvent 5 minutes before application of the film. Without such pre-cleaning, the results may be obscured by the presence of sebum accumulated on the skin surface, especially in subjects with oily skin conditions.

The following examples are intended to further illustrate specific embodiments of the invention.

Example 1 Approximately 50 ml of an adhesive solution (ethyl acetate solution containing 45% of a 60:25:15 terpolymer of 2-ethylhexyl acrylate, vinyl acetate and t-butylacrylamide) was applied to a 30 cm x 200 cm sheet of siliconized release paper. poured into one end. Using a doctor blade device, a gap of 0.1 mm was left between the surface of the release paper and the blade etch, and the above solution was uniformly and continuously spread over the surface of the release paper to coat it. 100
The coating was dried in a forced air oven at 0C to completely remove the solvent. After cooling to room temperature, the first sheet of microporous polypropylene film (Celgard 2400) with the same dimensions as the coated release paper was heated to 2 MPa.
The sheets were laminated by passing between pinch rollers set so as to apply a pressure of . (The laminate was also made with a hand roller with enough pressure to roll out the air bubbles and create firm, direct contact between the film and the sheet.) The laminate was then cut into 2.5 cm wide strips.
This was cut into a length of about 8 cm.

The skin of the subject's forehead was washed with soap and water and then degreased with a hexane-saturated gauze patch. After the skin surface was completely dry, the sebum-collecting strip was removed from the release paper and secured to the skin surface using gentle pressure to ensure proper adhesion. After 8 hours, the strips were removed and the number and size of clear areas (these occur precisely in secretory active sebaceous glands) was observed. The tape-like strips were placed on a non-porous surface, such as a glass plate, and stored for later comparison.

Example 2 An applied adhesive strip prepared as in Example 1 was extracted with a small amount of hexane for 10 minutes and then re-extracted with fresh hexane for another 10 minutes. Analysis of test strip extracts yielded 1 μg/cm ³ /3 hr. The sebum secretion rate (SER) of the same test site is
A well-established technique (Strauss & Pochi, J.of
Inv.Derm36293), it was measured by direct extraction of the area. In this measurement, the SER of 120μg/cm ³ /3hr
gave.

Chromatographic analysis of the two extracts showed that both samples had almost the same composition.

The invention as described above may of course be modified without departing from the spirit and scope of the invention.