Abstract:
A hair growth composition prepared from a platelet dry powder and a pharmaceutically acceptable solvent and/or excipient, which has from 1,000 to 15,000 platelets in every milliliter of the hair growth composition. The present invention also provides a method for treating a bald or thin hair area due to hair loss on the head of a human by administering the hair growth composition to the area with a dosage of 6-562 platelets per square centimeter of the area.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application is a continuation-in-part application of U.S. patent application Ser. No. 14/228,508, filed Mar. 28, 2014, which is a divisional application of U.S. patent application Ser. No. 13/200,650, filed Sep. 28, 2011, now abandoned, which claims the priority benefit of Taiwan Patent Application Number 99134114, filed Oct. 6, 2010. The disclosures of these prior patent applications are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a hair growth agent and usage thereof, and more particularly to a hair growth agent using compositions of platelet dry powder for promoting hair growth and usage thereof. 
       BACKGROUND OF THE INVENTION 
       [0003]    Having a bald head or thin hair area on head is a nagging problem many people face today, which subsequently makes developing methods of hair growth an important goal. For instance, in the published Taiwan patent application 200841886: a dual-agent of hair growth comprising active ingredients of 0.02%-2% of nitrite, and 0.5%-4% of acidic agents was disclosed; or in the published Taiwan patent application 200413014: a hair growth agent having abnormal expression of growth/transcription factors was disclosed. Moreover, in the announced Taiwan patents 128728, 191212, 260665, 474821, 490307, 501931, 592719, and in the published Taiwan patent applications 200509957, 200612904, and 200825399, all of which had disclosed hair growth agents using small-molecule chemicals as active ingredients thereof. In the announced Taiwan patent 518220, a hair growth agent formula using the FKBP ligands as active ingredients was disclosed, whereas in the announced Taiwan patent 531419, a hair growth agent formula having serine proteinases as active ingredients was disclosed. In addition, the published Taiwan patent application 200409650 had disclosed a hair growth agent formula using vitamins and/or co-enzymes as active ingredients; the published Taiwan patent applications 200509972, 200529876, and 200942251 had disclosed hair growth agent formulas including plant extracts as active ingredients, and the published Taiwan patent application 200815038 had disclosed a hair growth agent formula having estrogen as the active ingredient. However, a hair growth agent using a dry powder of platelets as the active ingredient has not been developed until now. In the US patents, the only patent that had disclosed a hair growth agent utilizing platelets-related substances as the active ingredient is the published patent application 20050049268, and the patent disclosed a hair growth agent using PDGF receptor tyrosine kinases inhibitor as the active ingredient. The present invention is the first to have disclosed a hair growth agent using a platelet dry powder as the active ingredient, which has been applied to promote hair growth in humans, and had achieved successful results subsequently. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention provides a new usage of applying a platelet dry powder to promote hair growth. 
         [0005]    The present invention provides a hair growth agent using a platelet dry powder as an active ingredient thereof. 
         [0006]    The present invention provides a method based on a formulation of platelet dry powder for promoting hair growth. 
         [0007]    The hair growth agent of the present invention is suitable for promoting hair growth in animals, and especially body hair in humans such as head hair and eyebrows. 
         [0008]    The hair growth agent of the present invention includes an effective dose of platelets for hair growth and a pharmaceutically acceptable solvent and/or excipient, wherein the effective dose refers to the presence of at least 1000 platelets in every milliliter of hair growth agent. In a preferred embodiment of the invention, there are 1000 to 15000 platelets present in every milliliter of hair growth agent. 
         [0009]    The source of said platelets of the hair growth agent of the present invention is a platelet dry powder. Said platelet dry powder is prepared from blood or blood preparations like platelet-rich plasma (PRP) by using specific methods, and comprises intact platelets. The methods for preparing the platelet dry powder may be any of the previously known methods for preparing platelet dry powders, as can be referred to in the announced Taiwan patents 1300806 and 1270375; the published Taiwan patent applications 201004659 and 200526680, and the announced U.S. Pat. Nos. 7,659,052, 7,202,020, 7,169,606, 6,060,233, 5,736,313, and 5,589,462. Moreover, the preparation of the platelet dry powder described in this invention is not limited to the methods disclosed in the aforesaid cited references. Due to the application of different preparation methods, said platelet dry powder may comprise low amounts of anticoagulants and protectants, such as the platelet dry powder prepared according to the method disclosed in the announced Taiwan patent TW-I270375, which includes low amounts of the anticoagulant acid citrate dextrose, cryoprecipitates, and thrombin, but since said components do not actually affect the performance of the platelet dry powder, it is not necessary to eliminate them therefrom. 
         [0010]    Said hair growth agent may be any of the previously known forms of drugs, such as solutions, suspensions, ointments, powders, and pills; is preferably in the form of solutions, ointments, or transdermal patches, and is more preferably in the form of sprays or ointments. In addition, the powders and pills may be prepared into other forms suitable for use in actual applications. 
         [0011]    Said pharmaceutically acceptable solvent refers to any solvents that can be ingested or applied externally by humans or animals, such as alcohol-water co-solvents, water, and saline, and is preferably water or saline. In addition, it is critical to ensure the amount of solvent added could maintain the effective dose of platelets. 
         [0012]    The pharmaceutically acceptable excipient is the previously known excipients, and applications thereof are determined according to the dosage form of the hair growth agent. 
         [0013]    Said effective dose of platelet dry powder refers to the presence of at least 1000 platelets in every milliliter of the hair growth agent; is preferably to be the presence of at least 2000 platelets therein, and is more preferably to be the presence of at least 5000 platelets therein. 
         [0014]    Said hair growth agent may be added with any effective ingredients that convey positive effects (such as anti-inflammatory ingredients, analgesic ingredients, nutritious ingredients, and/or ingredients promoting absorption), or any ingredients that do not have negative effects or side effects (such as spices). 
         [0015]    Said platelet dry powder may be heterologous, homologous, or autologous platelet dry powders. Considering the users&#39; possible concerns, the platelet dry powder is preferably a homologous or an autologous platelet dry powder, and is more preferably an autologous platelet dry powder. 
         [0016]    Generally speaking, the platelet-derivatives growth factors (PDGF) of platelets are approximately 40-200 pg/mL, as can be referred to in Vogt., et al.,  Determination of endogenous growth factors in human wound healing. Wound Repair Regeneration,  2004, 12(4): p. 485-492. The effectiveness of the hair growth agent of the present invention may be related to the long-term effectiveness of PDGF of the platelet dry powder, but the relationship thereof still requires further researches to confirm. 
         [0017]    A method for treating a bald or thin hair area due to hair loss on the head of a human according to the present invention comprises the following steps: 
         [0018]    determining whether the hair loss is caused by an radiation or chemotherapy treatment of cancer, or a surgery; and 
         [0019]    administering an effective amount of a hair growth composition to the area in need thereof to promote hair growth on the area, when the determination result is negative, wherein 
         [0020]    said hair growth composition comprises from 1,000 to 15,000 platelets in every milliliter of the hair growth composition, 
         [0021]    said hair growth composition is administered by spraying or spreading the hair growth composition on the area, so that 6-562 platelets per square centimeter of the area are administered. 
         [0022]    The method of the present invention preferably further comprises: 
         [0023]    cleaning the area prior to said administering step. 
         [0024]    Said cleaning refers to steps like rinsing, disinfecting, or combing hair away from the area into a condition suitable for undergoing said administering step. The necessity of rinsing the area generally depends on the cleanness of the area, and the area is preferably rinsed in advance or immediately before said administering step. Though disinfecting is not absolutely needed, it is preferable to have the area disinfected thoroughly. The need for combing hair from the area depends on actual requirements, and if the area does not actually possess any hair, or is almost without any hair, it does not require combing (yet if the areas are still surrounded by hair, it is ideal to comb the surrounding hair away from the area). If the areas actually possessed hair, it would be ideal to comb the hair into a condition suitable for said administering step. 
         [0025]    Said spraying or spreading step refers to spraying or spreading the hair growth agent having an effective dose of platelets over said cleaned area according to the form of the hair growth agent. For example, if the hair growth agent is a solution, it could be evenly sprayed on the area, and if the hair growth agent is an ointment, it could be evenly spread on the area. 
         [0026]    In one of the preferred embodiments of the present invention the solution is sprayed to the area 0.5 to 3.0 times, preferably once or twice, from a distance of 5-20 cm, wherein the volume per spray is about 0.20 ml and the area covered by the sprayed solution is about 16 cm 2 . Accordingly, 6-562 platelets per square centimeter of the area are administered when the solution has a concentration of 1000 to 15000 platelets per milliliter, for examples 6 platelets/cm 2  when the solution has a concentration of 1000 platelets/ml, 12 platelets/cm 2  for a concentration of 2000 platelets/ml, and 31 platelets/cm 2  for a concentration of 5000 platelets/ml. 
         [0027]    Said method for promoting hair growth is also suitable for use on animals having hair, including pets. 
         [0028]    In order to enhance the effects of hair growth promotion, a further absorption-enhancing step may be added before, during, or after the cleaning step, and is preferably added after disinfecting and before combing. 
         [0029]    Said absorption-enhancing step may be applied in any forms that facilitates the absorption of a hair growth agent, such as massaging or laser massaging to promote blood circulation to hair follicles, electromagnetic wave introduction, and micro-needle penetration; is preferably electromagnetic wave introduction or micro-needle penetration, and is more preferably micro-needle penetration. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0030]      FIG. 1   a  is a photograph showing the hair condition of the patient in Embodiment 1 before treatment, while  FIGS. 1   b ,  1   c , and  1   d  are photographs showing the hair condition of the patient after treatment. 
           [0031]      FIG. 2   a  is a photograph showing the hair condition of the patient in Embodiment 2 before treatment, while  FIGS. 2   b  and  2   c  are photographs showing the hair condition of the patient after treatment. 
           [0032]      FIG. 3   a  is a photograph showing the hair condition of the patient in Embodiment 3 before treatment, while  FIGS. 3   b  and  3   c  are photographs showing the hair condition of the patient after treatment. 
           [0033]      FIG. 4   a  is a photograph showing the hair condition of the patient in Embodiment 4 before treatment, while  FIGS. 4   b  and  4   c  are photographs showing the hair condition of the patient after treatment. 
           [0034]      FIG. 5   a  is a photograph showing the hair condition of the patient in Embodiment 5 before treatment, while  FIG. 5   b  is a photograph showing the hair condition of the patient after treatment. 
           [0035]      FIG. 6   a  is a photograph showing the hair condition of the patient in Embodiment 6 before treatment, while  FIG. 6   b  is a photograph showing the hair condition of the patient after treatment. 
           [0036]      FIG. 7   a  is a photograph showing the hair condition of the patient in Embodiment 7 before treatment, while  FIG. 7   b  is a photograph showing the hair condition of the patient after treatment. 
           [0037]      FIG. 8   a  is a photograph showing the hair condition of the patient in Embodiment 8 before treatment, while  FIG. 8   b  is a photograph showing the hair condition of the patient after treatment. 
           [0038]      FIG. 9   a  is a photograph showing the hair condition of the patient in Embodiment 9 before treatment, while  FIG. 9   b  is a photograph showing the hair condition of the patient after treatment. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0039]    The preferred embodiments are described hereafter in order to further elucidate the techniques of the invention: 
         [0040]    Testing example: 
         [0041]    The method disclosed in the announced Taiwan patent TW-I270375 was used to prepare a platelet dry powder, in which 1.0 g of platelet dry powder was obtained and added to saline to make up 5.0 mL of solution, then the PDGF titer of the solution was analyzed by using a spectrophotometer (U.S. Bio-Tek Instruments, Inc., Model μ-Quant) immediately after preparation (0 week), after 1 week, after 2 weeks, after 3 weeks, after 4 weeks, after 5 weeks, and after 6 weeks. Results from the analyses are shown in Table 1. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Changes of PDGF titer in solutions prepared 
               
               
                 from the platelet dry powder. 
               
             
          
           
               
                 Weeks 
                 0 
                 1 
                 2 
                 3 
                 4 
                 5 
                 6 
               
               
                   
               
               
                 PDGF (pg/mL) 
                 2930 
                 2795 
                 3012 
                 2854 
                 2822 
                 2776 
                 2785 
               
               
                   
               
             
          
         
       
     
         [0042]    The experimental figures indicated the PDGF titer of the platelet dry powder is very stable. 
       Embodiment 1  
       [0043]    The method disclosed in the announced patent TW-I270375 was used to prepare an autologous platelet dry powder from autologous blood in advance. The platelet dry powder was added to reverse osmosis (RO) water, in order to prepare a solution having 1000 platelets/ml, and then held in a spray bottle. The number of platelets in the solution was measured by using a Hematology Analyzer (Manufacturer: Sysmex, Model: KX-21). 
         [0044]    A patient was subjected to a treatment for promoting hair growth on the scalp once a week, which involved initially disinfecting a scalp area awaiting the promotion of hair growth, then rolling a micro-roller (purchased from the Korean company Daesung Medical Co. Ltd., Model Mi-Roll-1) over the disinfected area (micro-needle penetration), and finally evenly spraying the hair growth agent (solution) on the disinfected area. In addition, the area awaiting the promotion of hair growth was subjected to spraying of the hair growth agent evenly after washing hair everyday between every two treatments. The solution was sprayed twice, and the total volume of the solution sprayed was about 0.40 ml, so that there are about 25 platelets/cm 2  on the treated area. 
         [0045]      FIGS. 1   a  and  1   b  show the hair on the body area awaiting the promotion of hair growth before the treatments and 3 weeks after the treatments; though there appeared to be hair growth, it was insignificant. 
         [0046]    Similar to the treatment described above, but the concentration of the hair growth agent was increased to 2000 platelets/ml, and the evidence of hair growth in the fourth week was more significant than the previous three weeks, as could be seen in  FIG. 1   c.    
         [0047]    Similar to the aforesaid treatment, but the concentration of the hair growth agent was increased to 5000 platelets/ml, and the evidence of hair growth in the eighth week was even more significant than that in the fourth week; with abundant growth of new hair, as shown in  FIG. 1   d.    
       Embodiment 2  
       [0048]    Similar to Embodiment 1, but the platelet dry powder was a homologous platelet dry powder prepared from the blood in a blood bank, and the concentration of the hair growth agent (platelet number/ml of solution) was 5000.  FIGS. 2   a ,  2   b , and  2   c  show the hair conditions before the treatments, 5 weeks after the treatments, and 7 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results show that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 3 
       [0049]    Similar to Embodiment 2,  FIGS. 3   a ,  3   b , and  3   c  show the hair conditions before the treatments, as well as 1 week and 3 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results show that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 4 
       [0050]    Similar to Embodiment 2,  FIGS. 4   a ,  4   b , and  4   c  show the hair conditions before the treatments, as well as 5 weeks and 7 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results show that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 5 
       [0051]    Similar to Embodiment 2,  FIGS. 5   a  and  5   b  show the hair conditions before the treatments and 4 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results indicate that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 6  
       [0052]    Similar to Embodiment 2,  FIGS. 6   a  and  6   b  show the hair conditions before the treatments and 5 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results indicate that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 7 
       [0053]    Similar to Embodiment 2,  FIGS. 7   a  and  7   b  show the hair conditions before the treatments and 2 weeks after the treatments for the body area awaiting the promotion of hair growth, and the results indicate that there are significant growth of new hair, and the old hair became thickened. 
       Embodiment 8 
       [0054]    Similar to Embodiment 2,  FIGS. 8   a  and  8   b  show the hair conditions before the treatments and 6 weeks after the treatments for the body area awaiting the promotion of hair growth, and the pictures on the right of each of the photographs are the magnified pictures of the highlighted parts on the photographs. The results show that there is significant growth of new hair (black hair), and the old hair became thickened. 
       Embodiment 9 
       [0055]    Similar to Embodiment 2,  FIGS. 9   a  and  9   b  show the hair conditions before the treatments and 6 weeks after the treatments for the body area awaiting the promotion of hair growth, and the results show that there is significant growth of new hair, and the old hair became thickened. 
       Embodiments 10-24 
       [0056]    Similar to Embodiments 2-9, the platelet dry powder (abbreviated as PLT hereafter) was prepared by using the same method. The concentration of the hair growth agent (platelet number/ml of solution) and the effects of the treatments after 4 weeks and 8 weeks are presented in Table 2. In the table, the homologous PLT was prepared from the blood of a blood bank; the heterologous PLT was prepared from bovine blood, and the effects of the treatments at 4 and 8 weeks were recorded. 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Conditions and results of the treatments for Embodiments 10-24 
               
             
          
           
               
                   
                   
                   
                   
                 Effect 
               
               
                   
                   
                   
                 Effect of 4-week 
                 of 8-week 
               
               
                 Embodiment 
                 PLT 
                 Conc. 
                 treatment*-*** 
                 treatment*-*** 
               
               
                   
               
             
          
           
               
                 10 
                 Autologous 
                 1000 
                 Insignificant 
                 * 
               
               
                 11 
                 Autologous 
                 2000 
                 * 
                 ** 
               
               
                 12 
                 Autologous 
                 5000 
                 *** 
                 *** 
               
               
                 13 
                 Autologous 
                 10000 
                 *** 
                 *** 
               
               
                 14 
                 Autologous 
                 15000 
                 *** 
                 *** 
               
               
                 15 
                 Homologous 
                 1000 
                 Insignificant 
                 * 
               
               
                 16 
                 Homologous 
                 2000 
                 * 
                 ** 
               
               
                 17 
                 Homologous 
                 5000 
                 *** 
                 *** 
               
               
                 18 
                 Homologous 
                 10000 
                 *** 
                 *** 
               
               
                 19 
                 Homologous 
                 15000 
                 *** 
                 *** 
               
               
                 20 
                 Heterologous 
                 1000 
                 * 
                 ** 
               
               
                 21 
                 Heterologous 
                 2000 
                 ** 
                 *** 
               
               
                 22 
                 Heterologous 
                 5000 
                 *** 
                 *** 
               
               
                 23 
                 Heterologous 
                 10000 
                 *** 
                 *** 
               
               
                 24 
                 Heterologous 
                 15000 
                 *** 
                 *** 
               
               
                   
               
               
                 * Slight growth of new hair 
               
               
                 ** Apparent growth of new hair 
               
               
                 *** Significant growth of new hair, thickening of hair 
               
             
          
         
       
     
         [0057]    Results from Table 2 shows: 
         [0058]    In regard to the effects of the treatments, the heterologous PLT appeared to outperform the homologous PLT and the autologous PLT. However, the patients might still prefer to use homologous PLT or autologous PLT.