Method and composition for inhibiting aged skin

Abstract

A method and composition for inhibiting aged skin by topically applying to human skin a topical anti-aging composition. The method involves applying the human skin of afflicted area with an effective amount of the anti-aging composition containing chromium chloride, thiamine mononitrate, magnesium sulfate, and dmae bitartrate for a period of time sufficient to impart the appearance of aged skin. The topical composition is formulated into a pharmaceutically acceptable medium to optimize glucose uptake into the skin cells to properly replace iron production of skin cells, thereby inhibiting the appearance of aged skin.

Claims

1. A method of inhibiting skin aging in a human comprising topically applying, to an area of the human's skin, a composition comprising: (i) about 0.000422% to about 0.00169% by weight of chromium (III) chloride; (ii) about 0.676% to about 2.705% by weight of magnesium sulfate; (iii) about 0.676281% to about 2.028843% by weight of thiamine mononitrate; (iv) about 2.113378% to about 6.340136% by weight of dimethylaminoethanol (DMAE) bitartrate; and (v) a cosmetically-acceptable vehicle.

2. The method of claim 1, wherein the composition is in the form of a solution, a suspension, an ointment, a lotion, a cream, a gel, a spray, or an aerosol.

3. The method of claim 1, wherein the composition is in the form of an emulsion selected from the group consisting of water-in-oil emulsion, oil-in-water emulsion, silicone-in-water emulsion, water-in-silicone emulsion, wax-in-water emulsion, and water-oil-water triple emulsion.

4. The method of claim 1, wherein the composition further comprises an antioxidant.

5. The method of claim 1, wherein the composition further comprises a mineral oil.

6. The method of claim 1, wherein the composition further comprises glyceryl stearate.

7. The method of claim 1, wherein the composition further comprises propylene glycol.

8. The method of claim 1, wherein the cosmetically-acceptable vehicle is selected from the group consisting of water, a vegetable oil, an ester, an ether, an alcohol, a fatty alcohol, an isoparaffin, a silicone oil, a hydrocarbon oil, a polyol, a wax, and mixtures thereof.

9. The method of claim 1, wherein the cosmetically-acceptable vehicle is selected from the group consisting of water, deionized water, octyl palmitate, isopropyl myristate, isopropyl palmitate, dicapryl ether, dimethyl isosorbide, ethanol, isopropanol, cetyl alcohol, cetearyl alcohol, stearyl alcohol, biphenyl alcohol, isooctane, isododecane, hexadecane, cyclomethicone, dimethicone, dimethicone crosspolymer, a polysiloxane, an organo-modified polysiloxane, mineral oil, petrolatum, isoeicosane, polyisobutene, propylene glycol, glycerin, butylene glycol, pentylene glycol, hexylene glycol, a beeswax, a botanical wax, and mixtures thereof.

10. The method of claim 1, wherein the area of the human's skin is wrinkled.

11. The method of claim 1, wherein the composition is topically applied to the area of the human's skin at least once daily for at least one week.

12. The method of claim 11, wherein the composition is topically applied to the area of the human's skin twice daily.

13. The method of claim 1, wherein following the step of topical application, the chromium (III) chloride reduces the rate of insulin-mediated iron loading into cells of the human's skin.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) The present invention features a method for the treatment of aged skin by the topical administration of anti-aging skin composition to optimize glucose uptake into the skin cells to properly replace iron production of skin cells, thereby inhibiting the appearance of aged skin.

(2) The composition disclosed in the present invention contains chromium chloride, magnesium sulfate, thiamine mononitrate, and dmae bitartrate. The following details a study that clearly demonstrates the clinical benefit of the composition.

(3) The amount of chromium chloride which may be used in the present invention ranges from about 0.000422 to 0.00169 percent by weight and preferably about 0.676 to 2.705 percent by weight of magnesium sulfate of the composition.

(4) Chromium chloride, magnesium sulfate, thiamine mononitrate, and dmae bitartrate are available commercially and are made by a number of methods known to those of skill in the art.

(5) The composition can be incorporated into solution, lotion, cream, ointment and gel formulations for application to the aged skin of a subject. In such topical formulations, concentrations from 0.000422% to 0.00169% by weight of chromium chloride and 0.676% to 2.705% by weight of magnesium sulfate are incorporated into vehicle suitable for application to the skin. The resulting formulations are applied to the subject's aged skin from 1 to 2 times daily.

EXAMPLE 1

(6) A clinical study of human subjects with aged skin was carried out to show the effectiveness of the anti-aging skin composition of the present invention. A fixed dose combination of lotion formulations containing chromium chloride 0.000422% to 0.001695% by weight/total composition weight.

(7) Compositions containing 0.5 mg by weight of chromium chloride are topically administered at least once daily for 1 week to the human subjects with aged skin. At the end of one week period most subjects will demonstrate a significant decrease in the activity of their aged skin. Formulations A, B, C, D, and E (Table 1) were applied to each subject twice daily. Clinical appraisal was carried out at weekly intervals.

(8) TABLE-US-00001 TABLE 1 Weight (%) Components A B C D E Chromium 0.000422 0.000844 0.00127 0.00152 0.00169 chloride Magnesium 0.676 2.028 2.608 2.705 sulfate Thiamine 0.676281 1.05876 2.008209 2.028843 mononitrate Dmae bitartrate 2.113378 5.809252 6.340136 Total 100 100 100 100 100

(9) The results of the study are shown in Table 2 below:

(10) TABLE-US-00002 TABLE 2 Clinical Evaluation of Treatment Evaluation Time (Weeks) Formulation 1 2 3 4 A 0 1 1 1 B 1 2 3 3 C 2 3 3 3 D 3 3 4 4 E 2 3 3 4 0 = no response 1 = slight improvement 2 = good improvement 3 = very good improvement 4 = dramatic improvement

(11) The results of the foregoing tests show that chromium chloride used in the systemic treatment of aged skin (formulation A) is essentially ineffective as is the vehicle alone. However, the results of the foregoing tests shown a good improvement with magnesium sulfate, thiamine mononitrate, and dmae bitartrate (formulation C, D, and E).

EXAMPLE 2

(12) The study of Example 1 is repeated to show the efficacy of the anti-aging composition of the present invention (Table 3). The efficacy variables were subject's assessment of appearance of aged skin on a scale from 1 (marked improvement) to 5 (worse).

(13) TABLE-US-00003 TABLE 3 1 Marked Improvement 2 Moderated Improvement 3 Minimal Improvement 4 No Change 5 Worse

(14) Local tolerability measures of the signs and symptoms of skin irritation were considered adverse effects only if the severity of the expected signs and symptoms was such that an interruption of the subject's participation in the study, at his/her request or at the investigator's discretion, had occurred. Altered dosing regimens (such as every other day dosing) to manage irritation were not considered to be an interruption of the subject's participation in the study (Table 4).

(15) Safety and tolerability were assessed through evaluations of local tolerability and adverse events. At each visit, the investigator rated erythema, scaling, dryness, stinging/burning on a scale.

(16) TABLE-US-00004 TABLE 4 1 No reaction 2 Minimal reaction 3 Moderated reaction 4 Extreme reaction

(17) The results of the safety and tolerability study are shown in Table 5 below.

(18) TABLE-US-00005 TABLE 5 Efficacy and Safety Measurements Efficacy Evaluation Time (Weeks) Formulation 1 2 3 4 A 4 4 3 3 B 4 3 3 3 C 3 3 2 2 D 2 1 1 1 E 3 2 1 1 Safety and Tolerability Evaluation Time (Weeks) Formulation 1 2 3 4 A 3 3 3 3 B 3 2 2 2 C 2 2 2 2 D 1 1 1 1 E 2 1 1 1

(19) As this was an open-label study, only descriptive data presentations were made. No formal statistical hypotheses were tested. Descriptive statistics were used to summarize all data.

(20) Treatment with chromium chloride 0.00152 for up to 3 weeks showed remarkably continuing improvement in imparting aged skin. The greatest imparts of aged skin were seen after 3 weeks.

(21) Overall improvement was observed in the subject's assessment of appearance of aged skin. The median assessment was Moderated Improvement at week 2, and Marked Improvement at week 3.

(22) In conclusion, chromium chloride 0.00152% and magnesium sulfate 2.608% were well-tolerated and effective in anti-aging skin. Signs and symptoms of skin irritation (erythma, dryness, scaling, and stinging/burning) were mostly minimal or moderate and were transient.

(23) Safety findings were consistent with the known profile of chromium chloride. No unexpected, either systemic or dermatological, evidence of cumulative toxicity was observed over time. Consequently, extending treatment beyond 6 weeks does not suggest substantial additional risk for the subjects treated with chromium chloride 0.00152%.

(24) The efficacy of chromium chloride 0.00152% and magnesium sulfate 2.608% was showed continuing improvement greater than 95% for subjects treated for 4 weeks.

(25) As various modification could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying examples shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by any of the above described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.

(26) Having illustrated and described the principles of the present invention in a preferred embodiment, it will be apparent to those skilled in the art that the embodiment can be modified in arrangement and detail without departing from such principles. Any and all such embodiments are intended to be included within the scope of the following claims.