SILICONE PAD HAVING ACTIVE INGREDIENTS FOR SKIN CARE AND AGAINST SKIN AGING

Abstract

Summary

The present invention relates to a silicone pad for adhering to the skin, comprising at least one active ingredient for cosmetic skin care or against skin aging. In addition, the present invention relates to a cosmetic method for smoothing the skin, for the induction of scar remission, and it relates to the addition of active ingredients in the course in smoking cessation by means of applying a silicone pad to the skin of a person.

Claims

1-15. (canceled)

16. A silicone pad for adhering to the skin, wherein the silicone pad comprises at least one active ingredient suitable for cosmetic skin care or for preventing skin aging.

17. The silicone pad according to claim 16, wherein the silicone pad comprises an adhesive layer and a silicone body, wherein the adhesive layer consists essentially of silicone and contains the active ingredient.

18. The silicone pad according to claim 16, wherein the silicone pad is configured to rest on a back of a hand.

19. The silicone pad of claim 16, wherein the silicone pad has a weight sufficient to flatten the skin when the silicone pad is placed on the skin of a subject.

20. The silicone pad according to claim 16, wherein the active ingredient comprises nutrients.

21. The silicone pad according to claim 16, wherein the active ingredient is selected from the group consisting of vitamins, lipids, amino acids, polypeptides, antibiotics or their prodrugs, antioxidants, coenzymes, polysaccharides, and hydroxycarboxylic acids.

22. The silicone pad according to claim 16, wherein the active ingredient is selected from the group consisting of: vitamin A; vitamin C; vitamin E; vitamin B3; vitamin B5; vitamin B9; vitamin B12; coenzyme 10; arbutin; high and low molecular weight hyaluron; high and low molecular weight hyaluronic acid; collagen; b-resorcinol; 4-n-butylresorcinol; glycolic acid; salicylic acid; spirulina; chlorella; caviar extract; dimethylaminoethanol; shea butter; coconut oil; phytohormones; phytoestrogens; isoflavones; lignans; amino acids; oligopeptides; polypeptides; pentapeptides; glycerol; alpha-lipoic acid; and polyphenols.

23. The silicone pad according to claim 16, wherein the active ingredient is present in the silicone pad at a concentration in the range of about 0.5 to 3.0% (w/w), 1.0 to 2.0% (w/w), or about 1.6% (w/w).

24. The silicone pad according to claim 16, wherein the active ingredient is present in the silicone pad at a concentration in the range of 0.1 to 9.9% (w/w), 0.5 to 7.0% (w/w), or about 1.0% (w/w).

25. The silicone pad according to claim 16, wherein the silicone pad is configured for resting on a back of a hand, wherein the silicone pad is suitable for tightening wrinkles on the back of the hand.

26. The silicone pad according to claim 25, wherein the silicone pad comprises hinges.

27. A method for manufacturing a silicone pad for adhering to the skin comprising at least one active ingredient for cosmetic skin care or for preventing skin aging, comprising the step of applying an active ingredient to a silicone composition to produce a silicone pad.

28. The method for producing a silicone pad according to claim 27, further comprising the steps of: a) mixing an active ingredient with a silicone composition to produce an adhesive layer; and b) attaching the adhesive layer to a silicone body to produce the silicone pad.

29. A cosmetic method for smoothing the skin of a subject or for inducing scar remission in a subject, comprising applying a silicone pad according to claim 1 to the skin of the subject.

30. A method of treatment for treating a skin wound of a subject, comprising applying a silicone pad according to claim 1 to the skin of the subject.

31. A method of treatment for treating a nicotine addiction of a subject, comprising applying a silicone pad according to claim 1 to the skin of the subject.

32. The method of treatment according to claim 31, wherein the active ingredient is delivered to the skin on a regular basis.

Description

[0075] FIG. 1 shows a lateral cross-section of a silicone pad (1). The silicone pad (1) consists of a silicone body (3) and an adhesive layer (2) which is provided with active ingredients and which rests on the skin.

[0076] FIG. 2 shows a plan view of a finger-shaped silicone pad (1) exhibiting the shape of fingers, suitable for resting on a back of a hand (4). The silicone pad (1) covers the back of the hand (4) and extends beyond the metacarpophalangeal joints (5) to the proximal interphalangeal joints (6). The hinge region (7) are arranged directly above the metacarpophalangeal joints (5).

[0077] FIG. 3 shows the result of drug absorption studies. FIG. 3A depicts a silicone pad with an adhesive layer. The adhesive layer comprises 6 mg of powdered hyaluron (<20 T Dalton). The powder was stained with a green food coloring in order to demonstrate diffusion. For manufacturing a silicone pad, the adhesive layer was bonded to a silicone body. The silicone pad was applied daily to the skin of a subject for a period of 2 weeks.

[0078] It can be derived from this study, that the hyaluron does not accumulate in the upper layer, but was delivered to the skin's lower layers.

[0079] Additionally, one may derive from this study that the upper silicone layer functions as support layer. That is, it is characterized by a different strength and is essentially completely impermeable to water. On the other hand, the lower layer with the active ingredient, is softer and exhibits sufficient water permeability in order to deliver particles to the skin via skin contact (heat and moisture).

[0080] FIG. 3B shows the same silicone pad after 2 weeks of daily use. As may be seen clearly in FIG. 3B, the concentration of hyaluron in the silicone pad decreases markedly due to the diffusion into the skin, which is evidenced by a marked decrease of color of the silicone pad.

EXAMPLES

[0081] Manufacture of Silicone Pads

[0082] In the following, by way of example, the manufacturing of silicone pads is described, which may be used as a dcollet pad or as an eye pad.

[0083] Information Concerning the Manufacturing Process

[0084] The material used contains vinyl-terminated polydimethylsiloxanes (CAS No: 68083-19-2) and other auxiliaries for crosslinking. The silicone content is >95%.

[0085] The 2-component, addition-crosslinking basic material is metered out evenly into the appropriate mold utilizing a computer-controlled multicomponent metering system. Subsequently, the mold is moved into an oven in which it is subjected to vulcanization by radiant heat for a period of about 5-7 min and at a temperature of about 55-65 C. In the next step, the 2-component, addition-crosslinking, sticky adhesive gel is applied uniformly to the hardened basic material as a thin layer using another computer-controlled multicomponent metering system. This mold also is moved back into an oven in which the adhesive gel also undergoes vulcanization by radiant heat. The vulcanization process runs over a period of approx. 8-10 min. at a temperature of about 70-85 C. The finished products are then removed from their molds, checked and packaged.

[0086] Substances (hyaluron, aloe vera . . . ) to be added, whether as liquids or powders, are mixed with a component of the adhesive gel utilizing a mixer run at a speed of up to 25,000 rpm in order to ensure homogeneous incorporation. In order to prevent sedimentation or segregation of the substance, the silicone component is stirred repeatedly according to a fixed schedule, depending on the substance stirred in, such that consistent quality may be ensured.

Example 1: Dcollet Pad

[0087] Silicone pads were prepared from vinyl-terminated polydimethylsiloxanes (CAS No.: 68083-19-2) using conventional crosslinking agents as auxiliaries. According to the manufacturer's instructions, the silicone content is at least 95%. The production of these silicone pads has been described already elsewhere and corresponds, for example, to the silicone-based matrices disclosed in DE 101 14 382 A1. The silicone body of the silicone pads has the following values in (basic material): thickness 1.2 mm, weight 19.3 g. The adhesive layer has the following values: thickness 0.6 mm, weight 8.5 g. The weight fraction of added hyaluronic acid in the adhesive layer is 14 mg/8.5 g, thus is 1.6 (w/w).

[0088] The adhesive layer is prepared by stirring the powdered hyaluron (11-14 mg) into the silicone gel (8.5 g).

[0089] The silicone pad described above is suitable for use as a dcollet pad.

Example 2: Eye Pad

[0090] Silicone pads were prepared from vinyl-terminated polydimethylsiloxanes (CAS No.: 68083-19-2) using conventional crosslinking agents as auxiliaries. According to the manufacturer's instructions, the silicone content is at least 95%. The production of these silicone pads has been described already elsewhere and corresponds, for example, to the silicone-based matrices disclosed in DE 101 14 382 A1. The silicone body of the silicone pads has the following values in (basic material): thickness 1.2 mm, weight 19 g. The adhesive layer has the following values: thickness 0.7 mm, weight 9 g. The weight fraction of added hyaluronic acid in the adhesive layer is 1.5 mg/0.9 g, thus is 1.7 (w/w).

[0091] The adhesive layer is prepared by stirring the powdered hyaluron (1.5 mg to 2.0 mg) into the silicone gel (0.9 g).

[0092] The silicone pad described above is suitable for use as an eye pad.

Example 3: Efficacy Study

[0093] In an empirical efficacy study, silicone pads according to the invention and a blank were tested in a total of 15 subjects aged 29 to 61 years. The silicone pads listed in Table 1 were tested.

TABLE-US-00001 Silikonpad No. ingredients 1 2 hyaluron 3 collagen 4 aloe vera

[0094] The silicone pads were brought into contact with skin for at least 1 hour/day on at least 14 consecutive days, ideally overnight. Contact surfaces were the back of a hand, the region below the eyes, the dcollet, neck and forehead. Thereafter, the subjects were asked for their subjective opinion, a) whether the silicone pads were tolerable and could be used without problems, b) whether a visible wrinkle reduction and/or other positive effects were observed, and c) which of the above silicone pads 1 to 4 exhibited 1=best, 2=very good or 3=good activity and d) if there were any negative effects.

[0095] Of the 15 subjects, 14 subjects were of the subjective opinion that all silicone pads were well tolerated. A subject described the tolerability as good more or less.

[0096] Of the 15 subjects, 13 subjects were of the subjective opinion that a visible reduction in wrinkles and/or other positive effects were noted with respect to all silicone pads. Two subjects described that the visible wrinkle reduction and/or other positive effects occurred only with respect to silicone pads 2 to 3, while they were uncertain with respect to silicone pad 1.

[0097] With regard to the efficacy of the silicone pads 1 to 4, the subjective observations of the subjects are summarized in Table 2.

TABLE-US-00002 TABLE 2 Result of the efficacy study. Observed efficacy efficacy observed Silikonpad No. 1 (best) 2 (very good) 3 (good) 1 5 10 2 15 3 4 9 2 4 1 8 6

[0098] All 15 subjects reported that, regarding application of the silicone pads, negative effects were not detectable.

[0099] The empirical efficacy study proves that the silicone pads on the skin are well tolerated and exhibit no negative effects. The silicone pads having hyaluron as the active ingredient were demonstrated to have the best efficacy against wrinkling. Moreover, the silica pads supplied with collagen and, to a lesser extent, with aloe vera showed good efficacy. The silicone pads without active ingredient (blanks) exhibited the worst efficacy with respect to wrinkling.

[0100] Without wishing to be confined by any theory, the inventors of the present invention hypothesize that, due to the close or complete adherence of the silicone pad to the skin, the subjects slightly sweat such that the hyaluron or other active ingredients is detached due to the limited thickness of the adhesive layer and is eluted from the silicone material by the sweat. In this way, the silicone pad acts as a long-term and durable storage device on the skin surface and enables the achievement of the desired effect over the entire period of wearing, when utilized as a reusable product, even in the course of repeated or temporally interrupted treatment.

[0101] Without wishing to be confined by any theory, the inventors of the present invention hypothesize that in terms of efficacy of scar remission, the silicone pads of the present invention act by the following mechanism of action. By applying the silicone pad, a higher skin temperature may be achieved at which the physiological process of scar healing progresses faster. Alternatively, by applying the silicone pad, a higher humidity may be achieved enabling faster remission of the scar tissue by this process. Moreover, the process may be enhanced by the release of appropriate drugs.

Example 4: Studies on Skin Compatibility and Skin Tightening

[0102] In an empirical efficacy study, silicone pads according to the invention were tested in a total of 25 subjects aged 35 to 64 years. Silicone pads shaped as dcollet pad supplied with hyaluron were tested. The total weight of the silicone pad was 28 grams with 11 mg of added hyaluron.

[0103] The silicone pads were brought into overnight contact with the skin during a period of 14 consecutive days. The region of contact was the dcollet. Thereafter, the subjects were asked for their subjective opinion as to whether the silicone pads where tolerable and could be used without problems. Skin tightening was tested using a Visioscan VC 98 comparing pre- and post-application values.

[0104] No negative effects regarding the application of the silicone pads were encountered by any of the 25 subjects enrolled in the study. In particular, neither dryness nor reddening of the skin, as well as no unpleasant feeling on the skin due to the silicone pads were reported.

[0105] This empirical study of efficacy proves that the silicone pads supplied with active ingredients (here: hyaluron) are well tolerated on the skin, produce a measurable and sustainable skin smoothing and exhibited no negative effects.

[0106] Subjects stated that the product did not peel off the skin when worn overnight. The pad smoothed the skin on the dcollet and the skin attained a pleasant smoothness overnight.

[0107] Skin imperfections and furrows were visibly removed overnight.

[0108] Skin smoothness as measured by Visioscan VC 98 showed that it was smoothed, on average, by 19%. Skin smoothing was observed equally in all subjects.

LIST OF REFERENCE NUMBERS

[0109] 1. silicone pad [0110] 2. adhesive layer [0111] 3. silicone body [0112] 4. back of the hand [0113] 5. metacarpophalangeal joint [0114] 6. proximal interphalangeal joint [0115] 7. hinge region