Patent Publication Number: US-2006013781-A1

Title: Method and composition for producing enhanced fingernails

Description:
FIELD OF THE INVENTION  
      This invention employs methods and compositions for producing enhanced fingernails and toe nails.  
     BACKGROUND OF THE INVENTION  
      Fingernails and toe nails are composed primarily of a keratin matrix that includes their exposed surfaces and also contains a small amount of calcium and other chemical elements.  
      Human beings desire strong healthy nails for both cosmetic and medical reasons. However, some nails in normal use may crack and break and various treatments have become available to ameliorate these conditions.  
      It has been found that sometimes such nails can be strengthened and thus be prevented from cracking and breaking by using a fluoride treatment, since fluorides combine with the calcium present in the nails to form a reinforced keratin matrix. This type of treatment works well if the quantity of naturally occurring calcium is sufficient. Nevertheless, it generally takes about thirty days for optimum results and this treatment does not work well if there is not enough calcium present.  
      Subsequently, it has been found that when an application of a calcium material precedes the fluoride nail treatment, the nail strength is increased to the level of nails having a sufficient about of naturally occurring calcium.  
      However, when the natural nail is too thin the treatments described above do not work well. There is considerable variation in nail thickness found in the nails of the same subject. Applicants have observed that normal nail thickness can vary from a minimum of perhaps 0.005 inches to a maximum of perhaps 0.0300 inches. The thinner nails are the first to break. None of the treatments described above produce a positive increase in nail thickness.  
      The present invention is directed toward compositions and methods which produce increased nail thickness which in turn produces stronger nails and has the surprising additional result of nails with smoother exposed surfaces.  
     SUMMARY OF THE INVENTION  
      It is an object of the present invention to provide new methods and compositions which when applied to nails produces stronger nails of increased nail thickness.  
      Another object is to provide such new methods and compositions which do not employ fluoride compounds with or without prior calcium treatment.  
      Still another object is to provide new methods and compositions which when applied to nails not only produce stronger nails of increased thickness but also produce nails with smoother exposed surfaces.  
      These and other objects and advantages of this invention will either be explained or will become apparent hereinafter  
      In accordance with the principles of this invention, compounds containing both calcium and phosphorous ions are applied to the nail. The nail so treated was found to be stronger and thicker. In addition, surprisingly, the nail was found to display a smoother external surface.  
      These compounds include Calcium Fluorophosphate, Calcium Hypophosphate, Calcium Glycerophosphate and preferably Calcium Phosphate Monobasic. All these compounds are soluble in water and can be incorporated into cosmetically acceptable vehicles  
      In order to use these calcium phosphorous compounds in nail treatment, it is first necessary to dissolve them in a suitable solvent or incorporated into a cosmetically acceptable gel, paste or cream. These aforementioned compounds crystallize on the nail surface in the presence of keratin, causing remineralization of the nail and thus provides the enhanced nail characteristics of increased thickness, strength and smoothness.  
      The compounds can be formed into gels, pastes or creams employing cosmetic emulsion technology well known in the art. 
    
    
     EXAMPLES OF PREPARING CALCIUMPHOSPHOROUS COMPOUNDS IN CREAM FORM  
      The following examples of such a cream are as follows as shown in parts per weight: There are four examples, each being a different vertical column numbered 1 through 5 respectively.  
                                                               1   2   3   4   5                                        WATER PHASE                                     De-ionized water   76.90   77.40   77.70   76.90   76.90       Ethoxydigylcol   3.00   3.00   3.00   3.00   3.00       Glycerin   3.50   3.50   3.50   3.50   3.50       NaOH, 10% solution   0.70   0.70   0.70   0.70   0.70       Calcium Phosphate, monobasic   1.00   .50   —   —   —       Calcium Fluorophophate   —   —   0.20   —   —       Calcium Hyprohosphite   —   —   —   1.00   —       Calcium Glycerophosphate   —   —   —   —   1.00       OIL PHASE       Crodafos CES   4.0   4.0   4.0   4.0   4.0       Volpo S-2   0.40   0.40   0.40   0.40   0.40       Volpo S-10   1.20   1.20   1.20   1.20   1.20       Crodamol PMP   7.00   7.00   7.00   7.00   7.00       DC 344 Fluid   2.00   2.00   2.00   2.00   2.00       Nipastat   0.30   0.30   0.30   0.30   0.30                  
 
      The first four ingredients of the oil phase are available commercially from Croda USA; Nipastat from Nipa; and DC 344 Fluid from Dow Corning. The other ingredients are standard cosmetic ingredients widely used and well known in the art and are used for their normal purpose in forming an acceptable cosmetic cream. Various concentrations of the calcium, phosphorous compounds of this invention have demonstrated to effectively increase the thickness and strength of the fingernails.  
      The preferred calcium, phosphorous phases of this invention are solutions of the calcium, phosphorous compounds in a gel. The following examples of such solutions are as follows shown in parts per weight: There are four examples each being a different column numbered 6 through 10 respectively.  
                                                               6   7   8   9   10                                                            De-ionized Water   89.60   89.60   90.40   90.10   89.60       Propylene Glycol   8.00   8.00   8.00   8.00   8.00       Calcium Phosphate Monobasic   1.00   —   —   0.50   —       Calcium Hypophoshite   —   1.00   —   —   —       Calcium Fluorophosphate Dihydrate   —   —   0.20   —   —       Calcium Glycerophosphate   —   —   —   —   1.00       Natrosol 250 HHRCS   1.00   1.00   1.00   1.00   1.00       Methylparaben   0.20   0.20   0.20   0.20   0.20       Imidazolidinyl Urea   0.20   0.20   0.20   0.20   0.20                  
 
      The Natrosol 250 HHRCS is commercially available from Hercules. The other ingredients are standard cosmetic ingredients widely used and well known in the art.  
      Test Results  
      Two in vivo evaluations were made to determine the effects of treating fingernails with a gel containing 1.0% calcium phosphate monobasic. Before any treatment occurred, the fingernails were photographed and initial measurements were recorded.  
      The First Evaluation  
      First nail strength was measured on the nails of five healthy subjects. In order to measure nail strength, a platform was used which positions the fingernail over a flattened cylinder. The cylinder creates a gap resulting from the curve of the nail and remains constant from week to week. Since the distance form the nail to the top of the flattened cylinder remains constant, the force required to bend the nail flat against the flattened cylinder remains constant, the force required to bend the nail flat against the flattened cylinder can then be easily measured using a WAGNER force gauge. The gauge indicates the force required to bend the nail a constant distance in grams per square inch. Subjects applied the gel once a day for six weeks.  
                                                          Average   Average               Nail Strength   Nail Strength   %           Initial   1 week   Change                                                 Subject One   210   415   +98%           Subject Two   288   447   +55%           Subject Three   255   330   +29%           Subject Four   133   269   +102%                                              Average   Average               Nail Strength   Nail Strength   %           Initial   6 weeks   Change                                                 Subject One   210   520   +148%           Subject Two   288   360    +25%           Subject Three   255   429    +68%           Subject Four   133   315   +137%                      
 
      The above listed results demonstrate an average increase in fingernail strength of 71% after one week of use and 94.5% after six weeks.  
      The Second Evaluation  
      The second evaluation demonstrated a significant increase in fingernail thickness between before and after measurements. 20 healthy subjects applied the above mentioned gel, waited ten minutes, washed and dried their nails. The nails were measured using a Fowler &amp; NSK electronic digital caliper.  
      The data lend itself to a paired or related sample study design since the same subjects were observed under two conditions-before treatment and after. The hypothesis is that use of the test product will increase fingernail thickness. The null hypothesis is there is no difference in fingernail thickness. The non-parametric Wilcoxon matched-pair signed-rank test was used to test the hypothesis.  
      Non-Parametric Wilcoxon Matched-Pair Signed-Ranks Test  
                              Descriptive Statistics                                         N   Mean   Std. Deviation   Minimum   Maximum                                                 Before   196   .02014   .006793   .006   .042       After   196   .02222   .007086   .010   .042                  
 
     
       
         
           
               
            
               
                   
               
               
                   
               
               
                 Ranks 
               
            
           
           
               
               
               
               
            
               
                   
                 N 
                 Mean Rank 
                 Sum of Ranks 
               
               
                   
                   
               
            
           
           
               
               
               
               
               
            
               
                 After - Before 
                 Negative Ranks 
                  61 a   
                 74.38 
                 4537.00 
               
               
                   
                 Positive Ranks 
                 113 b   
                 94.58 
                 10688.00 
               
               
                   
                 Ties 
                  22 c   
               
               
                   
                 Total 
                 196 
               
               
                   
               
               
                     a After &lt; Before    
               
               
                     b After &gt; Before    
               
               
                     c After = Before    
               
            
           
         
       
     
     
       
         
           
               
            
               
                   
               
               
                   
               
               
                 Test Statistics b   
               
            
           
           
               
               
            
               
                   
                 After - Before 
               
               
                   
                   
               
            
           
           
               
               
               
            
               
                   
                 Z 
                 −4.630 a   
               
               
                   
                 Asymp. Sig. (2-tailed) 
                 .000 
               
               
                   
                   
               
               
                   
                     a Based on negative ranks.    
               
               
                   
                     b Wilcoxon Signed Ranks Test    
               
            
           
         
       
     
      The findings demonstrate that a statistically significant difference existed between the before and after product treatment groups. The results are significant at the 99% level of confidence and demonstrate that the use of this product increases fingernail thickness. The above analysis of the data shows an increase in the mean of the after measurements of 10%. The subjects&#39; fingernail thickness increased an average of 10%.  
      The panelists after treatment also completed a questionnaire as shown below.  
      Nail Serum Questionnaire1  
      DOES YOUR NAILS FEEL SMOOTHER?
          95% YES     5% NO        

      2. DO YOUR RIDGES LOOK BETTER?
          95% YES     5% NO        

      3. DID YOU SEE AN IMPROVEMENT IN THE APPEARANCE OF YOUR NAILS?
          95% YES     5% NO        

      4. DO YOUR NAILS APPEAR?
          HEALTHIER 79%     THICKER 79%     THINNER 0%     OTHER 0%        

      While the invention has been described with special attention to the test results, the protection solicited is to be limited only by the terms of the claims which follow.