Composition for increasing skin thickness

Abstract

A composition and method to increase skin thickness. The composition, preferably a topical lotion, may comprise skin thickening agents and a delivery agent, which in combination increases skin thickness, and may help reduce the possibility of injuries related to individuals suffering from thin or thinning skin, such as bruising or skin tears.

Claims

1. A composition for increasing skin thickness in an individual comprising: an effective amount of one or more skin thickening agents; and an effective amount of a delivery agent.

2. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition is a topical/transdermal lotion.

3. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition is a topical/transdermal cream.

4. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition is a topical/transdermal gel.

5. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition is a topical/transdermal ointment.

6. The composition for increasing skin thickness in an individual according to claim 1, wherein said delivery agent is a transdermal vehicle that transports or allows systemic absorption of the composition through the skin

7. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition includes one or more non-physiologically active ingredients.

8. The composition for increasing skin thickness in an individual according to claim 7, wherein said one or more non-physiologically active ingredients includes solvents, solubilizers, stiffening agents, surfactants, agents to prevent passage to lower skin layers, emulsifying agents, stabilizing agents, dispersing agents, thickening agents, coloring agents, preservatives, anti-oxidants, emollients, humectants, skin protectants, viscosity stabilizers, buffers, chelating agents, or combinations thereof.

9. The composition for increasing skin thickness in an individual according to claim 1, wherein said one or more skin thickening agents includes one or more vitamins.

10. The composition for increasing skin thickness in an individual according to claim 9, wherein said one or more vitamins includes effective amounts of Vitamin A, Vitamin B3 (Niacin), Vitamin C, Vitamin E, or combinations thereof.

11. The composition for increasing skin thickness in an individual according to claim 1, wherein said one or more skin thickening agents includes one or more one or more amino acids.

12. The composition for increasing skin thickness in an individual according to claim 11, wherein said one or more one or more amino acids includes Alanine, Cysteine, Aspartic Acid, Glutamic Acid, Phenylalanine, glycine, Histidine, Isoleucine, Lysine, Leucine, Methionine, Asparagine, Proline, Glutamine, Arginine, Serine, Threonine, Valine, Tryptophan, Tyrosine, or combinations thereof.

13. The composition for increasing skin thickness in an individual according to claim 1, wherein said composition further includes sodium.

14. A composition for increasing skin thickness in an individual comprising: one or more vitamins at a concentration of between about 0.01 grams and about 10 grams; one or more amino acids at a concentration of between about 10 grams and 900 grams; and a delivery agent at a concentration of about 25% to about 85%.

15. The composition for increasing skin thickness in an individual according to claim 14, wherein said composition includes effective amounts of one or more non-physiologically active ingredients.

16. The composition for increasing skin thickness in an individual according to claim X, wherein said one or more non-physiologically active ingredients includes solvents, solubilizers, stiffening agents, surfactants, agents to prevent passage to lower skin layers, emulsifying agents, stabilizing agents, dispersing agents, thickening agents, coloring agents, preservatives, anti-oxidants, emollients, humectants, skin protectants, viscosity stabilizers, buffers, chelating agents, or combinations thereof.

17. The composition for increasing skin thickness in an individual according to claim 14, wherein said composition further includes sodium.

18. A method for increasing skin thickness in an individual comprising: applying a composition comprising one or more vitamins at a concentration of between about 0.01 grams and about 10 grams; one or more amino acids at a concentration of between about 10 grams and 900 grams; and a delivery agent at a concentration of about 25% to about 85%, to a treatment site; wherein application of said composition to said treatment site results in an increase in skin thickness.

19. The method for increasing skin thickness in an individual according to claim 18, wherein said composition further includes sodium at a concentration of about 50 grams to about 225 grams.

20. The method for increasing skin thickness in an individual according to claim 18, wherein said composition includes effective amounts of one or more non-physiologically active ingredients.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0018] While the present invention is susceptible of embodiment in various forms, there is described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated.

[0019] The present invention provides a composition for increasing skin thickness in an individual. The present invention further provides a method of increasing skin thickness of an individual in need thereof. The composition may comprise skin thickening agents (which may also be defined as the active ingredients) and a transport agent which, in combination, increases skin thickness, and may help reduce the possibility of injuries related to individuals suffering from thin or thinning skin, such as bruising or skin tears.

[0020] As used herein, the term “effective amount” includes a sufficient amount of the skin thickening composition, when referring to the skin thickening composition in general, to provide the desired local or system effect, preferably without adverse side effects (i.e. unwanted or adverse effects of active ingredients or the composition as a whole), or to at least partially attain the desired effect. When referring to the individual component(s) of the skin thickening composition, “effective amount” may be defined as a sufficient amount of the individual component(s) to provide its intended or desired effect.

[0021] As used herein, the term “active ingredient” or “physiologically active ingredient” may be defined as ingredients, agents, compounds, individually or in combination, which exert a physiological effect, such as increase skin thickness, increase collagen levels, or reduce injures that result from thinning skin, such as bruising or skin tears.

[0022] As used herein, the term “about” can be defined as any value that is effective for its function, or a value which is 10%-35% above or below the stated concentration or amount.

[0023] The skin thickening composition may include effective amounts of one or more (in any combination) vitamins, such as but not limited to, Vitamin A, Vitamin B3 (Niacin), Vitamin C, and Vitamin E.

[0024] The skin thickening composition may include effective amounts of one or more amino (in any combination) acids, such as, but not limited to, Alanine, Cysteine, Aspartic Acid, Glutamic Acid, Phenylalanine, glycine, Histidine, Isoleucine, Lysine, Leucine, Methionine, Asparagine, Proline, Glutamine, Arginine, Serine, Threonine, Valine, Tryptophan, and Tyrosine. The amino acid may be in the L-stereoisomer form or the D-stereoisomer form. The amino acids may be supplied in a purified form or as part of a protein composition that can be broken to form or provide the amino acid. The amino acids may be supplied in powder form and mixed with water or other solvents or in an oil. The use of the term “amino acids” may also include amino acid derivatives, either naturally occurring or man-made, such as for example, β-Alanine, or amino acid metabolites, such the proline metabolite, hydroxyproline.

[0025] The skin thickening composition may include sodium.

[0026] The skin thickening composition may include an effective amount of a delivery agent. The delivery agent may be a transdermal vehicle that transports or allows systemic absorption of the composition through the skin. The delivery agent may be a transdermal base, such as LIPODERM, pluronic lecithin organogel (PLO, vehicle consisting of water, pluronic acid, and lecithin), or HRT transfer agent (Hormone Replacement Therapy transfer agent, [LIPODERM, transdermal base with liposomal components, or ARTEVIS, hydrogel with skin permeation enhancers and polymer network]). The delivery agent may be added in any effective amount, such as, but not limited to between 30% and 70% of the skin thickening composition.

[0027] The skin thickening composition may include one or more non-physiologically active ingredients. As used herein, the use of the term “non-physiologically active ingredients” may be defined as ingredients, agents, compounds that may be admixed with the active ingredients, but do not function to provide or exert a physiological effect. The one or more (in any combination) non-physiologically active ingredients may include effective amounts of solvents, solubilizers, stiffening agents, surfactants, agents to prevent passage to lower skin layers, emulsifying agents, stabilizing agents, dispersing agents, thickening agents, coloring agents, preservatives (which may include anti-microbial agents, antifungal agents), anti-oxidants, emollients, humectants, skin protectants, viscosity stabilizers, buffers, chelating agents, other non-physiologically active ingredients known to one of skill in the art, or combinations thereof.

[0028] In one embodiment, the skin thickening composition may be a topical/transdermal lotion.

[0029] In one embodiment, the skin thickening composition may be a topical/transdermal cream.

[0030] In one embodiment, the skin thickening composition may be a topical/transdermal gel.

[0031] In one embodiment, the skin thickening composition may be a topical/transdermal ointment.

[0032] In one embodiment, the skin thickening composition may be in the form of a gel or liquid.

[0033] The skin thickening composition is designed to increase skin thickness of individuals, and may comprise, preferably in combination, skin thickening agents (which may also be defined as the active ingredients), a transport agent, and, optionally, one or more non-active ingredients/agents.

[0034] The following are illustrative examples the composition:

[0035] Skin thickening composition: Example 1A:

TABLE-US-00001 Component Concentration/Amount/Range Skin thickening agent(s) Effective amounts Delivery agent(s) Effective amounts

[0036] Skin thickening composition: Example 1B:

TABLE-US-00002 Component Concentration/Amount/Range Skin thickening agent(s) Effective amounts Delivery agent(s) Effective amounts Sodium Effective amounts

[0037] Skin thickening composition: Example 2A

TABLE-US-00003 Component Concentration/Amount/Range Skin thickening agent(s) Effective amounts Delivery agent(s) Effective amounts Non-physiologically active ingredients Effective amounts

[0038] Skin thickening composition: Example 2B

TABLE-US-00004 Component Concentration/Amount/Range Skin thickening agent(s) Effective amounts Delivery agent(s) Effective amounts Sodium Effective amounts Non-physiologically active ingredients Effective amounts

[0039] Skin thickening composition: Example 3A

TABLE-US-00005 Component Concentration/Amount/Range One or more vitamins Effective amounts One or more amino acids Effective amounts Transport molecule/agent Effective amounts Non-physiologically active ingredients Optional/effective amounts

[0040] Skin thickening composition: Example 3B

TABLE-US-00006 Component Concentration/Amount/Range One or more vitamins Effective amounts One or more amino acids Effective amounts Sodium Effective amounts Transport molecule/agent Effective amounts Non-physiologically active ingredients Optional/effective amounts

[0041] Skin thickening composition: Example 4A

TABLE-US-00007 Component Concentration/Amount/Range (grams) Vitamin A About 0.01 g to about 0.1 Vitamin C About 15 g to about 60 g Vitamin E About 2.25 g to about 10 g Niacin (Vitamin B-3) About 2.25 g to about 10 g L-Leucine About 10 g to about 40 g L-Valine About 10 g to about 40 g L-Isoleucine About 10 g to about 40 g L-Lysine About 10 g to about 40 g L-Phenylalanine About 10 g to about 40 g L-Threonine About 10 g to about 40 g L-Methionine About 10 g to about 40 g L-Tryptophan About 10 g to about 40 g L-Alanine About 20 g to about 100 g L-Arginine About 15 g to about 70 g L-Aspartic Acid About 220 to about 900 g L-Cysteine About 15 g to about 60 g L-Glutamic Acid About 20 g to about 90 g L-Glycine About 50 g to about 200 g L-Histidine About 15 g to about 60 g L-Isoleucine About 3 g to about 20 g L-Proline About 35 g to about 140 g L-Serine About 5 g to about 30 L-Threonine About 5 g to about 20 L-Tyrosine About 1 g to about 10 g Sodium About 50 g to about 225 g Delivery Agent:HRT transfer about 25% to about 85% agent Non-physiologically active Optional/effective amounts ingredients

[0042] Skin thickening composition: Example 4B

TABLE-US-00008 Component Concentration/Amount/Range (grams) Vitamin A 0.05 g Vitamin C 30 g Vitamin E 4.5 g Niacin (Vitamin B-3) 4.5 g L-Leucine 18 g L-Valine 18 g L-Isoleucine 18 g L-Lysine 18 g L-Phenylalanine 18 g L-Threonine 18 g L-Methionine 19 g L-Tryptophan 18 g L-Alanine 4 0 g L-Arginine 35 g L-Aspartic Acid 438 g L-Cysteine 2 8 g L-Glutamic Acid 45 g L-Glycine 100 g L-Histidine 30 g L-Isoleucine 7 g L-Proline 68 g L-Serine 14 g L-Threonine 9 g L-Tyrosine 3 g Sodium 110 g Delivery Agent:HRT transfer Effective amounts agent Non-physiologically active Optional/effective amounts ingredients

[0043] Skin thickening composition: Example 5A

TABLE-US-00009 Component Concentration/Amount/Range (grams) Vitamin A about 0.01 g to about 0.1 g Vitamin C about 10 g to about 60 g Vitamin E about 2.25 g to about 9 g Niacin (Vitamin B-3) about 2.25 g to about 9 g L-Alanine about 20 g to about 100 g L-Arginine about 20 g to about 100 g L-Aspartic Acid about 10 g to about 75 g L-Glutamic Acid about 35 g to about 140 g L-Glycine about 55 g to about 225 g L-Histidine about 1 g to about 10 g L-Hydroxylysine about 30 g to about 125 g L-Isoleucine about 5 g to about 25 g L-Leucine about 5 g to about 50 g L-Lysine about 10 g to about 50 g L-Methionine about 1 g to about 10 g L-Phenylalanine about 5 g to about 25 g L-Proline about 30 g to about 125 g L-Serine about 10 g to about 50 g L-Threonine about 5 g to about 20 g L-Tyrosine about 1 g to about 6 g L-Valine about 5 g to about 40 g L-Hydroxyproline about 30 g to about 125 g Sodium about 50 g to about 225 g Delivery Agent:HRT transfer about 25% to about 85% agent Non-physiologically active Optional/effective amounts ingredients

[0044] Skin thickening composition: Example 5B

TABLE-US-00010 Component Concentration/Amount (grams) Vitamin A 0.05 g Vitamin C 30 g Vitamin E 4.5 g Niacin (Vitamin B-3) 4.5 g L-Alanine 44 g L-Arginine 45 g L-Aspartic Acid 3 6 g L-Glutamic Acid 67 g L-Glycine 111 g L-Histidine 4 g L-Hydroxylysine 62 g L-Isoleucine 8 g L-Leucine 16 g L-Lysine 18 g L-Methionine 3 g L-Phenylalanine 11 g L-Proline 62 g L-Serine 18 g L-Threonine 10 g L-Tyrosine 3 g L-Valine 13 g L-Hydroxyproline 62 g Sodium 110 g Delivery Agent:HRT transfer Effective amounts agent Non-physiologically active Optional/effective amounts ingredients

[0045] In use, the method of increasing skin thickness of an individual in need thereof, may comprise applying to an individual's skin a topical or transdermal composition, such as any composition described in Example 1-5B. The composition may be applied daily, such as twice a day or as needed.

[0046] Results of Application of a topical or transdermal composition as described in Examples 1-5B.

[0047] The composition was applied to the same location, for example, on the dorsal forearms, elbow to the wrist, on an individual male, over 50 years old, daily 2 time a day, over a predetermined time period. Skin thickness measurements were undertaken using high frequency ultrasound. Measurements were taken at several locations. Preferably, the composition was applied after a bath or shower when the skin was wet to aid in absorption through the skin.

[0048] A. First Application applied to the left and right arm: Date Applied: Nov. 24, 2020

[0049] Initial skin measurements:

[0050] Right Prox: 0.18 cm

[0051] Right Mid: 0.19 cm

[0052] Right Distal 0.27 cm

[0053] Right Average: 0.213 cm

[0054] Left Prox: 0.23 cm

[0055] Left Mid: 0.21 cm

[0056] Left Distal: 0.23 cm

[0057] Left Avg: 0.22

[0058] Overall: 0.2165 cm

[0059] B. Second measurement date: Feb. 1, 2021

[0060] Right Prox; 0.25 cm

[0061] Right Mid: 0.23 cm

[0062] Right Distal: 0.21 cm

[0063] Right Average: 0.23 cm

[0064] Left Prox: 0.25 cm

[0065] Left Mid: 0.27

[0066] Left Distal: 0.27 cm

[0067] Left Average: 0.253 cm

[0068] Overall Average: 0.2475 cm

[0069] C. Third measurement date: May 26, 2021

[0070] Right Prox: 0.35 cm

[0071] Right Mid: 0.31 cm

[0072] Right Distal: 0.36 cm

[0073] Right average: 0.34 cm

[0074] Left Prox: 0.41 cm

[0075] Left Mid: 0.37 CM

[0076] Left Distal: 0.39 cm

[0077] Average Left: 0.39 cm

[0078] Overall skin thickness to date of third measurement: 0.365 cm

[0079] Change of thickness: 0.1485 cm, representing 65% increase in thickness of skin within 6 months.

[0080] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.

[0081] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary, and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.