Method of preparing and composition for treatment of hair and scalp
FIELD OF THE INVENTION 
     The present invention relates to a composition for treatment of hair and scalp. In particular, the present invention includes components which improve hair thickness, hair fullness and overall hair and scalp health. 
     BACKGROUND ART 
     Human beings are very conscious of their appearance and especially of the hair on their heads. Over the years, many formulations and treatments have been proposed to treat the hair and the scalp with objectives ranging from the curing of baldness to the cleansing of the hair. Mathews et al in U.S. Pat. No. 4,814,351 disclose a scalp treatment for reduction of hair loss which contains a chelating agent, a surfactant, a conditioner, a vitamin derivative and other ingredients. U.S. Pat. No. 5,116,607 to Jones discloses a hair dressing including petrolatum, a wax, a surfactant, and a hydrolyzed protein. A beautifying hair kit is disclosed in U.S. Pat. No. 5,181,529 issued to Roberts. The kit contains urea, glyoxal and hydrolyzed protein together with other components. Lundmark, in U.S. Pat. No. 5,277,164 discloses a hair treatment composition containing panthenol, allantoin and monohydric alcohol as essential ingredients. In U.S. Pat. No. 5,270,035, Cheminto discloses a hair conditioner containing disodium cocoamphodiacetate, panthenol, polysorbate 80, astringents, nutrients and herb extracts. 
     Also, various compositions for skin treatment have been disclosed. Goodman et al, in U.S. Pat. No. 4,883,659, discloses a skin treatment preparation which includes a homopolymer, a polyamino sugar condensate, soy protein, amino acids, polysorbate 80, natural oils, panthenol and allantoin acetyl methionine. Taitler et al, in U.S. Pat. No. 5,011,855  discloses a cosmetic and dermatological composition containing γ-linolenic acid obtained from vegetable oils such as borage seed oil. A wound and burn dressing containing gellan gum is disclosed by Mahoney in U.S. Pat. No. 5,256,477. 
     The composition of the present invention, when used in a regular regimen, include components which improve the overall health of the person&#39;s hair and scalp and produce hair which has improved appearance due to the improved hair thickness and hair fullness. 
     Thus, although some of the components of the present composition have been used for hair treatment and other components have been used for various skin treatments, no one has disclosed a composition which includes the materials of the present invention prepared by the method disclosed herein. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a composition for treatment of the hair and scalp which improves the health of the hair and the scalp and improves the appearance of the hair by improving the thickness and fullness of the hair. 
     In accordance with the teachings of the present invention, there is disclosed an aqueous composition for the treatment of hair and scalp comprising a chelating agent, gellan gum, a vitamin precursor, a preservative, biotin, a vitamin derivative, γ-linolenic acid, menthol, a liposome, a conditioner, a solubilizer, a conditioner/humectant, folic acid, a polyamino sugar condensate and diluent ingredients. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The following is a preferred embodiment of a composition for the treatment of hair and scalp and a method for preparing the composition. 
     The method involves the combining of ingredients into eight (8) phases and sequentially mixing the ingredients from the phases. The mixing is preferably performed using propeller type agitation. The composition in Table I has been found to be very effective in achieving the objectives of the present invention. 
     
                                           TABLE I                                 
__________________________________________________________________________
              CTFA                                                        
PHASE                                                                     
     INGREDIENT                                                           
              NOMENCLATURE                                                
                         SUPPLIER                                         
                                % WT RANGE                                
__________________________________________________________________________
A    Water    Water      (USP)  70.00-80.00                               
     Hamp-ene Na2                                                         
              disodium EDTA                                               
                         (Grace)                                          
                                0.01-0.10                                 
     KelcoGel F                                                           
              Gellan gum (Kelco)                                          
                                0.10-1.00                                 
B    Sorbitol-70                                                          
              sorbitol   (Dow)  0.50-3.00                                 
     d1-Panthenol                                                         
              panthenol  (Roche)                                          
                                0.10-1.50                                 
     Methylparaben                                                        
              methylparaben                                               
                         (USP)  0.10-0.50                                 
     Germall 115                                                          
              imidazolidinyl                                              
                         (Sutton)                                         
                                0.10-0.50                                 
              urea                                                        
     Potassium                                                            
              potassium  (USP)  0.01-0.50                                 
     Sorbate  sorbate                                                     
     Biotin,  biotin     (Roche)                                          
                                0.01-1.00                                 
     USP-FCC                                                              
C    Nicotinate C                                                         
              tocopherol (BASF) 0.10-1.50                                 
              nicotinate                                                  
     Borage Oil                                                           
              borage seed oil                                             
                         (Int&#39;l Flora                                     
                                0.10-1.00                                 
                         Tech-602                                         
                         982-1125)                                        
     Frescolat                                                            
              menthyl lactate                                             
                         (Haarman &amp;                                       
                                0.50-3.00                                 
                         Reimer)                                          
     Exsymol  tocopherol        0.01-0.50                                 
     Nanospheres                                                          
              acetate                                                     
     100 Vitamin                                                          
     E Acetate                                                            
     LPO                                                                  
     Menthol, USP                                                         
              menthol    (Barnet)                                         
                                0.10-1.00                                 
     Natural                                                              
     Almeth   allantoin acetyl                                            
                         (ICI)  0.10-1.00                                 
              methionine                                                  
     Cremophor                                                            
              PEG-40, hydro-                                              
                         (BASF) 0.10-5.00                                 
     RH-40    genated                                                     
              castor oil                                                  
     Sandoxylate                                                          
              PPG-2-Isodeceth-                                            
                         (Sandoz)                                         
                                0.10-5.00                                 
     SX-424   12                                                          
     Volpo-10 oleth-10   (Croda)                                          
                                0.10-3.00                                 
     Tween 80 polysorbate 80                                              
                         (ICI)  0.10-4.00                                 
D    Water    water      (USP)  1.00-5.00                                 
E    Merquat Plus                                                         
              polyquaternium-39                                           
                         (Calgon)                                         
                                0.10-3.00                                 
     3330                                                                 
F    Folic Acid,                                                          
              folic acid (Roche)                                          
                                0.01-0.50                                 
     USP                                                                  
     Sodium   sodium            0.10-2.00                                 
     hydroxide                                                            
              hydroxide                                                   
     Solution,                                                            
     10% (to pH                                                           
     6.5-6.9)                                                             
G    Water    water      (USP)  2.00-4.00                                 
     Aqualizer EJ                                                         
              polyamino  (Kolmar)                                         
                                0.01-0.25                                 
              sugar                                                       
              condensate                                                  
H    Hydrosoy hydrolyzed soy                                              
                         (Croda)                                          
                                0.01-3.00                                 
     2000 SF  protein                                                     
     Fragrance           (Belmay)                                         
                                0.01-1.00                                 
     #64872-492                                                           
TOTAL                           100.00                                    
__________________________________________________________________________
 
    
     The commercial name and supplier of the components are listed together with the nomenclature of the Cosmetic, Toiletry and Fragrance Association (CTFA). The water must be good quality deionized water since the concentrations of cations (i.e., Ca, Na, K, and Mg) present in normal water will cause the Gellan Gum to gel prematurely and/or form a &#34;hard&#34; gel. Also, the chelating agent (ethylenediaminetetraacetic acid disodium salt) serves as a means of reducing the concentration of cations in addition to acting as an antimicrobiological agent. The Gellan Gel is a thickener. Sorbitol serves as a humectant. Panthenol acts as a moisturizer and is a vitamin B precursor which is helpful in maintaining healthy hair. Methylparaben, imadazolidinyl urea and potassium sorbate all are preservatives. These preservatives may be used individually or in combination with each other. Biotin is a vitamin B member and contributes to healthy hair and scalp. Tocophenyl nicotinate is a vitamin E derivative which stimulates blood flow in the scalp. Borage seed oil is a vegetable oil containing γ-linolenic acid, an essential fatty acid which acts as a therapeutic and nutritional agent. Menthyl lactate provides a cooling sensation to the skin without irritation. Tocopherol acetate is a liposome. Menthol acts as a cooling agent and provides a fragrance to the composition. Allantoin acetyl methionine is a soothing conditioner. The emulsifiers, PEG-40 hydrogenated castor oil and Oleth 10, assist in the formation of the emulsion. PPG-2 Isodeceth-12 is a solublizer to assist in the solvation of the components in water and polysorbate 80 is effective as a sebum solublizer. Polyquaternium-39 is a conditioner/humectant. Folic acid is a B vitamin. The polyamino sugar condensate includes urea which mimics natural moisturizing factors in the skin. Hydrolyzed soy protein is a source of protein and amino acids. Fragrance is added to provide a desired pleasing aroma. 
     The water of Phase A is heated in a first container to approximately 90° C. and maintained at this temperature for approximately 30 minutes. The water is cooled to approximately 75° C. and is rapidly stirred. The chelating agent is added. The Gellan Gel is slowly sprinkled into the stirring mix. After completion of addition of the Gellan Gum, the components are mixed for 15-20 minutes with high speed agitation. After the Gellan Gel is well dispersed, the components are mixed with medium stirring for approximately 15-20 minutes at 75° C. to deaerate. 
     The components of Phase A are moderately stirred while the temperature is maintained at 75° C. and the ingredients of Phase B are added in sequence as follows: sorbitol, panthenol, methylparaben, imidazolidinyl urea, potassium sorbate and biotin. The preservatives may be added individually or combined in any manner. The Phase AB mix is moderately stirred for approximately 10-20 minutes, avoiding the incorporation of air. 
     In a separate, second container, the ingredients of Phase C are combined. These are tocophenyl nicotinate, borage seed oil, menthyl lactate (optional), tocophenyl acetate, menthol, allantoin acetyl methionine, emulsifier such as PEG 40 hydrogenated castor oil and/or Oleth 10 (optional), solublizer such as PPG-2-Isodeceth-1 and/or polysorbate 80 (optional). The ingredients are heated to approximately 70°-75° C. and stirred. The water of Phase D is heated to approximately 75° C. and slowly added to the Phase C components at approximately 75° C. with moderate stirring. After the mixture of Phase CD is homogeneous, the Phase CD mix is added to the first container with Phase AB with moderate stirring and maintaining the temperature at approximately 75° C. 
     Phase E, polyquaternium-39 is added to the Phase ABCD mix at 75° C. with moderate stirring. The Phase ABCDE is stirred for approximately 10-15 minutes until uniformly mixed. 
     The Phase ABCDE components are cooled to 60° C. and the folic acid of Phase F is added. The batch turns to an orange-yellow color. The batch is mixed for approximately 15 minutes. A solution of 10% sodium hydroxide is added with moderate stirring to a pH of approximately 6.4 to 7.0. The batch will become white or yellow-white in color. The batch is cooled to approximately 45° C. 
     The Phase G components (polyamino sugar condensate and water) are combined and added to the Phase ABCDEF batch. The resulting batch is moderately stirred for approximately 15 minutes. 
     The Phase ABCDEFG components are cooled to approximately 40° C. and the hydrolyzed soy protein and fragrance of Phase H are added in sequence and moderately stirred for about 15 minutes until the entire batch is uniform. 
     The Phase ABCDEFGH is cooled to room temperature and the pH is adjusted to approximately 6.4 to 7.0 with the sodium hydroxide solution if required. The preferred pH is 6.5. The viscosity is tested and if necessary, 0.2% aqueous sodium chloride solution is added with stirring to obtain a viscosity of approximately 5,000 to 100,000 centipoise (cps). The viscosity has been measured typically, using a Brookfield Viscosimeter, Model LVT, Spindle E at 6 rpm and 18° C. The specific gravity of the composition ranges from approximately 1.000 to 1.020 and the preferred specific gravity is 1.013 g/cc. 
     The applicant authorized an independent test group to evaluate the composition of the present invention in a double blind study to determine the effects of hair and scalp regimens on hair thickness, hair fullness, and overall hair and scalp health when used according to label instructions. Forty-eight subjects completed the study. At the initiation of the study, visit I, the subjects completed a health questionnaire, an informed consent agreement, an eligibility questionnaire, and a hair and scalp assessment questionnaire. Clinical examinations for hair thickness and hair fullness were conducted. The composition of the present invention was distributed to 26 subjects and a placebo which was visually similar but which contained no active ingredients, was distributed to 22 subjects. All of the subjects were instructed both verbally and in writing how to use the product. The subjects returned for visit II following approximately one week of usage and completed a second hair and scalp assessment questionnaire as well as a final questionnaire. Clinical examinations for hair thickness and hair fullness were again conducted. Clinical examinations revealed statistically significant increases (p≦0.05) in hair thickness and hair fullness from visit I to visit II in the active group. No statistically significant increases were observed, however, in hair thickness and hair fullness from visit I to visit II in the placebo group. Analysis of the visit II hair and scalp assessment questionnaire revealed that 46-62% of the subjects in the active group had self-perceived improvements in hair thickness, hair fullness, and hair and scalp health. Of the subjects in the placebo group, 41-50% had self-perceived improvements in hair thickness, hair fullness, and hair and scalp health. 
     A second study was conducted by the independent test group using twelve subjects. At visit I, subjects completed a health questionnaire, an informed consent agreement, an eligibility questionnaire, and a hair and scalp questionnaire. Clinical examinations for hair thickness and hair fullness were conducted, and three subjects with self-perceived hair damage had approximately ten hairs plucked from the area of damage. These hairs were examined for split ends and cuticle damage using a Zeiss Derma Vision® Stereomicroscope/Video System. The composition of the present invention was distributed to the subjects, and the subjects were instructed both verbally and in writing how to use the product. Subjects returned for visit II following one week of usage and completed a second hair and scalp questionnaire as well as a final questionnaire. Clinical examinations for hair thickness and hair fullness were again conducted, and the three subjects with self-perceived hair damage at visit I again had approximately ten hairs plucked from the area of damage. Analysis of damaged hair samples showed examples of repair in split ends and cuticle damage from visit I to visit II. However, because of the small hair fiber sample size, no conclusion can be drawn about the effect of the test material on hair damage repair. Clinical examinations revealed statistically significant increases (p≦0.05) in hair thickness and hair fullness from visit I to visit II. Furthermore, analysis of the visit II hair and scalp questionnaire revealed that 75%-83% of the subjects had self-perceived moderate or large improvements in hair thickness and hair fullness. 
     Obviously, many modifications may be made without departing from the basic spirit of the present invention. Accordingly, it will be appreciated by those skilled in the art that within the scope of the appended claims, the invention may be practiced other than has been specifically described herein.