Hair growth and Anti-hair greying composition

Abstract

Disclosed herein is an improved pharmaceutical and dermatological hair growth and anti-hair greying composition and to the process of preparation thereof.

Description

[0001] “HAIR GROWTH AND ANTI-HAIR GREYING COMPOSITION”

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS:

[0003] This Application is Patent of Addition of the pending Indian Patent Application no. 202321053030 having the priority date 08 / 08 / 2023. This invention comprises an improvement of the hair growth composition claimed in the specification of Patent Application no.202321053030.

[0004] TECHNICAL FIELD OF THE INVENTION:

[0005] The present invention relates to an improved pharmaceutical and dermatological hair growth and anti-hair greying composition and to the process for preparation thereof.

[0006] BACKGROUND AND PRIOR ART:

[0007] Hair loss is a common condition affecting millions of individuals worldwide, with significant implications for self-esteem and quality of life. It can result from various factors, including genetics, hormonal imbalances, stress, and environmental influences. Androgenetic alopecia (pattern baldness) is the most prevalent cause of hair loss, leading to the progressive thinning of hair and, ultimately, baldness. While many treatment options exist, including topical therapies, oral medications, and surgical interventions, the demand for more effective and minimally invasive solutions continues to rise.

[0008] The reasons for hair loss could be heredity, medical conditions, hormonal changes, diet related or a normal part of aging. Certain medications including chemotherapy, HIV / AIDS, hypothyroidism, and malnutrition including iron deficiency cause hair loss. The common types of hair loss include male- or female-pattern hair loss, Alopecia Areata, and a thinning of hair known as Telogen Effluvium. There are two types of Alopecia (hair loss): non-scarring alopecia and scarring alopecia.

[0009] There are various types of hair including terminal hair, vellus hair, and modified terminal hair such as in the eyebrows and eyelashes. Terminal hairs are coarse, pigmented, long hairs in which the bulb of the hair follicle is situated deep in the dermis. Vellus hairs, on the other hand, are fine, thin, non-pigmented short hairs in which the hair bulb is located superficially in the dermis. As alopecia progresses, a transition takes place in the area of approaching baldness wherein the hairs themselves are changing from the terminal to the vellus type. The size of the hair follicles is known to decrease.

[0010] Treatments for alopecia include the medications minoxidil (or finasteride) and hair transplant surgery. Alopecia areata may be treated by steroid injections in the affected area, but these need to be frequently repeated to be effective.

[0011] Many growth factors have been implicated in controlling different signals in the cycle of hair growth, with some playing major and some playing minor roles. Biomimetic peptides are known to play a role in combating hair loss. These peptides are designed to mimic the natural signaling molecules in the body, mainly growth factors, specifically targeting the hair follicle to promote hair growth. By enhancing cellular communication and stimulating the activity of dermal papilla cells, biomimetic peptides encourage the growth phase (anagen) of the hair cycle, leading to stronger and healthier hair. They also improve the microenvironment around the hair follicle, creating favorable conditions for regeneration.

[0012] Exosomes, derived from Human umbilical cord mesenchymal stem cells, animal and plant sources, have emerged as a promising adjunct in regenerative medicine. Exosomes are small extracellular vesicles that carry bioactive molecules, such as growth factors, cytokines, and miRNAs, capable of promoting cellular repair and regeneration. Plant-derived exosomes are especially valued for their biocompatibility and potential to reduce inflammation and oxidative stress, both of which are implicated in hair loss.

[0013] The combination of biomimetic peptides with plant-derived exosomes offers a synergistic approach to hair loss treatment. Biomimetic peptides stimulate hair follicle activity, while exosomes enhance cellular communication, repair damaged tissues, and create an optimal environment for hair growth. Together, they provide a potent, non-invasive therapy that addresses both the causes of hair loss and the need for follicular regeneration, offering a comprehensive solution for individuals seeking improved hair density and quality.

[0014] Hair greying is a common phenomenon typically associated with aging, characterized by the gradual loss of pigment in hair follicles. This process results from a complex interplay of genetic, environmental, and biochemical factors. Melanin is a natural pigment responsible for determining the coloration of hair, skin, and eyes. Melanin is generated by specialized cells known as melanocytes situated in the basal layer of the epidermis and within the hair follicles. In addition to its involvement in pigmentation, melanin serves a protective purpose by absorbing and dispersing ultraviolet rays from the sun, thereby shielding cells from harm. As the production of melanin decreases with age, the hair undergoes a transition from its original color to grey and ultimately white, resulting in a change in its visual presentation. Additionally, oxidative stress and the accumulation of reactive oxygen species (ROS) contribute to the degradation of melanin, further accelerating the greying process.

[0015] Melanogenesis is a multifaceted process influenced by transcription factors including tyrosinase, TRP1 (tyrosinase- related protein- 1), and DCT (dopachrome tautomerase; TRP2; tyrosinase-related protein-2). As the expression level of these factors increases, melanin synthesis is stimulated. Hair loss and hair greying are two prevalent conditions often associated with aging, though they can occur independently or simultaneously. Both conditions share some common underlying mechanisms, such as genetic influences and the impact of oxidative stress, making their simultaneous occurrence a notable feature of the aging process.

[0016] The applicant’s earlier filed Indian Patent application no. 202321053030 though discloses a hair growth composition for prevention of hair loss and for stimulation of hair regrowth, however, do not show the activity against hair greying or reversing the hair greying in the subjects.

[0017] There was an unmet need in the art to provide compositions which can prevent hair loss, improve hair growth as well as prevent hair greying with no adverse effects. In light of the same, the present inventors carried out further improvements in the composition and observed that by adding Exosomes and a combination of Peptides along with Growth factors to the hair growth composition and observed that not only was the hair growth improved in terms of Hair density and Shaft diameter of the hair but also the greying of the hair was prevented and grey hair turned to black hair.

[0018] OBJECT OF INVENTION

[0019] It is therefore an object of the present invention to provide an improved hair growth composition for effective prevention of hair loss and for stimulation of hair regrowth and further prevent and reverse hair greying which is potently organic, non-toxic, biocompatible and hence favors its prolonged use with minimal to no side effects.

[0020] The other objective is to provide the hair growth composition that can serve both as a cosmetic composition as well as dermatological composition with no adverse side effects and to the process for preparation thereof. SUMMARY OF THE INVENTION:

[0021] In an aspect, the present invention provides a pharmaceutical and dermatological hair growth and anti-hair greying composition comprising;

[0022] i. Peptides selected from Caffeoyl Tripeptide-1 in an amount of 0.05 mg / L to 10 mg / L; Stem Cell Factor (SCF) including its biomimetic variant sh- Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh- Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75mg / L; alone or mixtures thereof.

[0023] ii. Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50,000mg / L to 100,000mg / L alone or mixtures thereof.

[0024] iii. Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L;

[0025] iv. Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide-8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500 mg / L;

[0026] along with

[0027] v. Vascular endothelial growth factor (Human oligopeptide- 11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L;

[0028] vi. Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of 0.01mg / L – 100 mg / L; vii. Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 0.01mg / L – 100mg / L; viii. Copper tripeptide 1 in an amount of O.lmg / L - 500 mg / L;

[0029] ix. Keratinocyte growth factor including its biomimetic analogue Sh- Polypeptide-3 in an amount of O. Olmg / L - 100 mg / L;

[0030] x. Thymosin β4 including its biomimetic analogue Sh-Oligopeptide-4 in an amount of 0.005mg / L - 100 mg / L;

[0031] xi. Noggin including its biomimetic variant sh-Polypeptide-13 in an amount of 9-11 mg / L,

[0032] xii. Decapeptide- 10 (CG-Keramin2) in an amount of 8.5-10.5mg / L;

[0033] xiii. Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005mg / L; xiv. Vitamins, minerals, nucleic acids and amino acids in appropriate concentration;

[0034] and pharmaceutical and dermatological acceptable excipients.

[0035] In another aspect, the pharmaceutical and dermatological hair growth and anti-hair greying composition of the present invention may further comprise other peptides selected from; Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide- 11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; and Oligopeptide-74 (CG-Grotene) in appropriate concentration and the like.

[0036] The vitamins are selected from the group consisting of Vitamin A in an amount of 0.01 - 0.50 mg / L, Vitamin Bl in an amount of 0.01 - 0.50 mg / L, Vitamin B2 in an amount of 0.01 - 0.50 mg / L, Vitamin B3 in an amount of 1.0 - 50 mg / L, Vitamin B5 in an amount of 0.001 - 0.050 mg / L, Vitamin B6 in an amount of 0.01 - 0.10 mg / L, Vitamin B7 in an amount of 0.001 - 0.050 mg / L, Vitamin B12 in an amount of 0.01 - 0.50 mg / L, Vitamin C in an amount of 10 - 80 mg / L, Vitamin E in an amount of 0.001 - 0.050 mg / L, Vitamin K in an amount of 0.001 - 0.050 mg / L and the like; minerals and mineral salts selected from the group consisting of Calcium salt in an amount of 100 - 300 mg / L, Sodium salt in an amount of 5000 - 7000 mg / L, Potassium salt in an amount of 200 - 600 mg / L, Magnesium salt in an amount of 10 - 200 mg / L and the like, nucleic acids selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine and essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine.

[0037] The nucleic acids each are in the range of 1-50 mg / L, essential and non-essential amino acid in the range of 2-150 mg / L.

[0038] The pharmaceutically and dermatologically acceptable excipients include but are not limited to diluents, carriers, buffering agents, humectants, colorants and the like in appropriate amount.

[0039] In a further aspect, present invention provides a process for the preparation of the pharmaceutical and dermatological hair growth and anti-hair greying composition comprising;

[0040] i. Adding the Peptides selected from Caffeoyl Tripeptide-1 in an amount of 0.05 mg / L to 10 mg / L; Stem Cell Factor (SCF) including its biomimetic variant sh-Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh-Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75mg / L, Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50,000mg / L to 100,000mg / L; Growth factors selected from Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L; Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide- 8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500 mg / L; Vascular endothelial growth factor (Human oligopeptide-11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L; Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of 0.01 mg / L - 100 mg / L; Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 0.01mg / L – 100mg / L; Copper tripeptide 1 in an amount of O.lmg / L - 500 mg / L; Keratinocyte growth factor including its biomimetic analogue Sh-Polypeptide-3 in an amount of O. Olmg / L - 100 mg / L; Thymosin β4 including its biomimetic analogue Sh- Oligopeptide-4 in an amount of 0.005mg / L - 100 mg / L; Noggin including its biomimetic variant sh-Polypeptide-13in an amount of 9-llmg / L, Decapeptide- 10 (CG-Keramin2) in an amount of 8.5-10.5mg / L and Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005mg / L; vitamins, minerals, nucleic acids and amino acids in appropriate concentration; along with pharmaceutically and dermatologically acceptable excipients to distilled water at ambient temperature in the disperser set at 750-1000rpm;

[0041] ii. Adjusting the pH and filtering the final product followed by filling the vials.

[0042] In another aspect, the process of the present invention may further comprise addition of other peptides selected from Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide- 11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; Oligopeptide-74 (CG-Grotene) in appropriate concentration and the like and the Botulinum Toxin Type A is in the concentration of about 100U / ml and the like. In another aspect, the present hair growth and anti-hair greying composition may be formulated for intradermal, dermaroller or topical administration. The formulation may be available as ready-to-inject sterile glass vial or as a powder¬ liquid composition in two separate glass vials that have to be reconstituted prior to administration. It may also be available as prefilled syringes and combined with Hyaluronic Acid.

[0043] The composition of the present invention exhibits synergistic effect of the growth factors, peptides and exosomes by preventing hair loss, promoting hair growth and preventing / reversing hair greying and thereby improving the bodily appearance of a person.

[0044] The composition of the present invention is effective in preventing hair loss by stimulating hair follicles and promoting hair growth, where such hair growth improves the bodily appearance of said person. It is also effective in preventing greying of hair and reversing the greying of hair by increasing melanin biosynthesis in hair follicles.

[0045] In yet another aspect, the present invention provides a method for preventing hair loss by stimulating hair follicles and promoting hair growth and improving the bodily appearance of a person comprising administering the pharmaceutical and dermatological hair growth composition in an effective amount to a person in need.

[0046] In another aspect, the present invention provides a method for preventing greying of hair and reversing the greying of hair by increasing melanin biosynthesis in hair follicles and elevating the mRNA expression levels of melanin synthesis factors. In another aspect, the pharmaceutical and dermatological hair growth and anti-hair greying composition may be administered intradermally or applied topically.

[0047] In yet another aspect, the pharmaceutical and dermatological hair growth and anti¬ hair greying composition may be administered through micro-needling techniques such as the nappage technique, through dermaroller, or hair filler inserts.

[0048] The hair growth and anti-hair greying composition of the present invention may be co-administered with one or more hair growth promoting compounds selected from the group consisting of minoxidil, minoxidil analogues, minoxidil derivatives, anti-androgens and 5-alpha- reductase inhibitors and such like in appropriate concentration.

[0049] In another aspect, the present hair growth and anti-hair greying composition is used for preventing hair loss and promoting hair growth and preventing and reversing hair greying.

[0050] In yet another aspect, the present invention provides a medical device in the form of dermaroller, prefilled syringes, vials or hair filler inserts for administering the hair growth composition of the present invention in an effective amount to the subject.

[0051] In another aspect, the present invention provides a kit comprising;

[0052] a) prefilled syringes or vials or a dermaroller comprising said pharmaceutical or dermatological composition or hair filler insert embedded in hyaluronic acid enriched with said composition; and

[0053] b) instruction manual for application.

[0054] BRIEF DESCRIPTION OF THE DRAWINGS:

[0055] Figure 1: depicts effect of present hair growth and anti-hair greying composition on melanin synthesis Figure 2: depicts effect of present hair growth and anti-hair greying composition on the mRNA levels of melanin synthesis factors.

[0056] Figure 3: depicts effect of the present hair growth and anti-hair greying composition on inhibiting hair loss and stimulating hair growth

[0057] The novel features which are considered characteristic for the invention are set forth in particular in the appended claims. Other aspects of the invention will become evident upon reference to the following detailed description. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description.

[0058] DETAILED DESCRIPTION OF THE INVENTION:

[0059] In line with the object of present invention, there is provided a hair growth composition for nourishment of hair follicles, for preventing hair loss, stimulating hair regrowth, preventing hair greying and reversing hair greying in mammals.

[0060] As used herein the term ‘effective amount’ means an amount which stimulates hair growth associated with hair loss afflictions like male pattern baldness, or insults such as radiation or chemotherapy.

[0061] The term ‘growth factor’ relates to a naturally occurring protein capable of stimulating cellular growth, proliferation and cellular differentiation.

[0062] The present invention is based on the synergistic effect of the growth factors, peptides and exosomes effective in preventing hair loss, promoting hair growth, preventing greying of hair and reversing the greying of hair by increasing melanin biosynthesis in hair follicles where such hair growth improves the bodily appearance of said person. In an embodiment, the present invention provides a hair growth and anti-hair greying composition that can stimulate the conversion of vellus hair to terminal hair as well as increase the rate of growth of terminal hair. Further, the hair growth composition of the present invention prevents greying of hair and reverses hair greying.

[0063] Accordingly, in an embodiment, the present invention discloses a pharmaceutical and dermatological hair growth and anti-hair greying composition comprising: i. Peptides selected from Caffeoyl Tripeptide-1 in an amount of 0.05 mg / L to 10 mg / L; Stem Cell Factor (SCF) including its biomimetic variant sh- Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh- Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75mg / L; alone or mixtures thereof.

[0064] ii. Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50,000mg / L to 100,000mg / L alone or mixtures thereof.

[0065] iii. Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L;

[0066] iv. Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide-8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500 mg / L;

[0067] along with v. Vascular endothelial growth factor (Human oligopeptide- 11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L;

[0068] vi. Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of O. Olmg / L - 100 mg / L;

[0069] vii. Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 0.01mg / L – 100mg / L; viii. Copper tripeptide 1 in an amount of O.lmg / L - 500 mg / L;

[0070] ix. Keratinocyte growth factor including its biomimetic analogue Sh- Polypeptide-3 in an amount of O. Olmg / L - 100 mg / L;

[0071] x. Thymosin β4 including its biomimetic analogue Sh-Oligopeptide-4 in an amount of 0.005mg / L - 100 mg / L;

[0072] xi. Noggin including its biomimetic variant sh-Polypeptide-13 in an amount of 9-11 mg / L,

[0073] xii. Decapeptide- 10 (CG-Keramin2) in an amount of 8.5-10.5mg / L;

[0074] xiii. Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005mg / L; xiv. Vitamins, minerals, nucleic acids and amino acids in appropriate concentration;

[0075] and pharmaceutical and dermatological acceptable excipients.

[0076] In another embodiment, the pharmaceutical and dermatological hair growth and anti-hair greying composition of the present invention may comprise other peptides selected from; Elastin scalp peptide (Tetrapetide 32) in the concentration of 15-25 ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of 15- 25 ppm; Acetyl Tetrapetide-3 in the concentration of 50-100 ppm; Octapeptide- 11 in the concentration of 15-25 ppm; Octapeptide-20 in the concentration of 10- 20 ppm; Palmitoyl pentapeptide -3 in the concentration of 50-100; Oligopeptide- 74 (CG-Grotene) in the concentration of 15-25 ppm and the like. The vitamins are selected from the group consisting of Vitamin A in an amount of 0.01 - 0.50 mg / L, Vitamin Bl in an amount of 0.01 - 0.50 mg / L, Vitamin B2 in an amount of 0.01 - 0.50 mg / L, Vitamin B3 in an amount of 1.0 - 50 mg / L, Vitamin B5 in an amount of 0.001 - 0.050 mg / L, Vitamin B6 in an amount of 0.01 - 0.10 mg / L, Vitamin B7 in an amount of 0.001 - 0.050 mg / L, Vitamin B12 in an amount of 0.01 - 0.50 mg / L, Vitamin C in an amount of 10 - 80 mg / L, Vitamin E in an amount of 0.001 - 0.050 mg / L, Vitamin K in an amount of 0.001 - 0.050 mg / L and the like; minerals and mineral salts selected from the group consisting of Calcium salt in an amount of 100 - 300 mg / L, Sodium salt in an amount of 5000 - 7000 mg / L, Potassium salt in an amount of 200 - 600 mg / L, Magnesium salt in an amount of 10 - 200 mg / L and the like, nucleic acids selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine in an amount of 1-50 mg / L and essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine in an amount of 2-150 mg / L.

[0077] The pharmaceutical and dermatological acceptable excipients include but are not limited to diluents, carriers, buffering agents, colorants and the like in appropriate amount. Preferably, suitable carriers or diluents include but are not limited to distilled water, physiologic saline, bacteriostatic saline, (saline containing 0.9mg / ml benzyl alcohol).

[0078] In an embodiment, the biomimetic analogues are derived from potato.

[0079] The present invention further encompasses the compositions involving one or more growth factors in addition to the composition of invention as mentioned above.

[0080] In yet another embodiment, the present invention discloses a pharmaceutical and dermatological hair growth and anti-hair greying composition, comprising: i. Peptides selected from Caffeoyl Tripeptide-1 in an amount of Img / L; Stem Cell Factor (SCF) including its biomimetic variant sh-Polypeptide-4 in an amount of 1 mg / L; Caffeoyl sh-Decapeptide-9 in an amount of 1 mg / L; Tetrapeptide-32 in an amount of 1 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.5mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh-Polypeptide- 66 in an amount of O.lOmg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 10 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 50mg / L; alone or mixtures thereof.

[0081] ii. Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 7.5mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 100,000mg / L alone or mixtures thereof.

[0082] iii. Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of lOmg / L;

[0083] iv. Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide-8 and / or Sh-Polypeptide-59 in an amount of 50mg / L; along with

[0084] v. Vascular endothelial growth factor (Human oligopeptide- 11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 5 mg / L;

[0085] vi. Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of 2 mg / L;

[0086] vii. Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 2 mg / L;

[0087] viii. Copper tripeptide 1 in an amount of lOmg / L;

[0088] ix. Keratinocyte growth factor including its biomimetic analogue Sh- Polypeptide-3 in an amount of Img / L;

[0089] x. Thymosin β4 including its biomimetic analogue Sh-Oligopeptide-4 in an amount of O. Olmg / L;

[0090] xi. Noggin including its biomimetic variant sh-Polypeptide-13 in an amount of 10 mg / L; xii. Decapeptide- 10 (CG-Keramin2) in an amount of 10 mg / L;

[0091] xiii. Octapeptide-2 (Prohairin-β4) in an amount of 0.005 mg / L;

[0092] xiv. Vitamins, minerals, nucleic acids and amino acids in appropriate concentration;

[0093] and pharmaceutical and dermatological acceptable excipients.

[0094] In an embodiment, the above composition may comprise other peptides in are selected from, Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Botulinum Toxin Type A in the concentration of about 100U / ml; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide- 11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; Oligopeptide-74 (CG-Grotene) in appropriate concentration and the like.

[0095] The vitamins in above hair growth and anti-hair greying composition are selected from the group consisting of Vitamin A in an amount of 0.01 - 0.50 mg / L, Vitamin Bl in an amount of 0.01 - 0.50 mg / L, Vitamin B2 in an amount of 0.01 - 0.50 mg / L, Vitamin B3 in an amount of 1.0 - 50 mg / L, Vitamin B5 in an amount of 0.001 - 0.050 mg / L, Vitamin B6 in an amount of 0.01 - 0.10 mg / L, Vitamin B7 in an amount of 0.001 - 0.050 mg / L, Vitamin B12 in an amount of 0.01 - 0.50 mg / L, Vitamin C in an amount of 10 - 80 mg / L, Vitamin E in an amount of 0.001 - 0.050 mg / L, Vitamin K in an amount of 0.001 - 0.050 mg / L and the like; minerals and mineral salts selected from the group consisting of Calcium salt in an amount of 100 - 300 mg / L, Sodium salt in an amount of 5000 - 7000 mg / L, Potassium salt in an amount of 200 - 600 mg / L, Magnesium salt in an amount of 10 - 200 mg / L and the like, nucleic acids selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine in an amount of 1-50 mg / L and essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine in an amount of 2-150 mg / L.

[0096] The pharmaceutical and dermatological acceptable excipients include but are not limited to diluents, carriers, buffering agents, colorants, humectants and the like in appropriate amount. Preferably, suitable carriers or diluents include but are not limited to distilled water, physiologic saline, bacteriostatic saline, (saline containing 0.9mg / ml benzyl alcohol).

[0097] The composition of the present invention may comprise the known growth factors selected from the group consisting of follistatin, Wnt proteins, β catenin proteins, stem cell factor, and platelet derived growth factors in appropriate concentration. In another embodiment, the present hair growth and anti-hair greying composition may be formulated for intradermal, dermaroller or topical administration. The formulation may be available as vials, prefilled syringes.

[0098] In an embodiment, the present invention disclose a medical device in the form of dermaroller, prefilled syringes, vials or hair filler inserts for administering the composition of the present invention in an effective amount to the subject.

[0099] In another embodiment, the present composition may be available as ready-to- inject sterile glass vial or as a powder-liquid composition in two separate glass vials that have to be reconstituted prior to administration. It may also be available as prefilled syringes and combined with Hyaluronic Acid.

[0100] The present hair growth and anti-hair greying composition as described herein above is an enhanced drug delivery system by incorporating the key ingredients of the composition in a targeted Lecithin-Derived Liposomal encapsulation through metered high concentrations (100 nm~) of liposomes. It is formulated using sonication and Micro-fluidizer technology. Lipoencapsulation / Liposomal derivatives are Lecithin-Derived Liposomes. High concentrations (100 nm~) of liposomes are formulated using sonication and Microfluidizer technology.

[0101] In yet another embodiment, the hair growth and anti-hair greying composition of the present invention is prepared by a process comprising,

[0102] i. Adding the Peptides selected from Caffeoyl Tripeptide-1 in an amount of 0.05 mg / L to 10 mg / L; Stem Cell Factor (SCF) including its biomimetic variant sh-Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh-Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75mg / L, Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50,000mg / L to 100,000mg / L; Growth factors selected from Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L; Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide- 8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500 mg / L; Vascular endothelial growth factor (Human oligopeptide-11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L; Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of 0.01 mg / L - 100 mg / L; Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 0.01mg / L – 100mg / L; Copper tripeptide 1 in an amount of O.lmg / L - 500 mg / L; Keratinocyte growth factor including its biomimetic analogue Sh-Polypeptide-3 in an amount of O. Olmg / L - 100 mg / L; Thymosin β4 including its biomimetic analogue Sh- Oligopeptide-4 in an amount of 0.005mg / L - 100 mg / L; Noggin including its biomimetic variant sh-Polypeptide-13 in an amount of 9-11 mg / L, Decapeptide- 10 (CG-Keramin2) in an amount of 8.5 - 10.5mg / L and Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005mg / L; vitamins, minerals, nucleic acids and amino acids in appropriate concentration; along with pharmaceutically and dermatologically acceptable excipients to distilled water at ambient temperature in the disperser set at 750-1000rpm;

[0103] ii. Adjusting the pH and filtering the final product followed by filling the vials.

[0104] In another embodiment, above process may further comprise addition of other peptides selected from Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide-11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; Oligopeptide-74 (CG- Grotene) in appropriate concentration and the like.

[0105] The vitamins in above process are selected from the group consisting of Vitamin A in an amount of 0.01 - 0.50 mg / L, Vitamin Bl in an amount of 0.01 - 0.50 mg / L, Vitamin B2 in an amount of 0.01 - 0.50 mg / L, Vitamin B3 in an amount of 1.0 - 50 mg / L, Vitamin B5 in an amount of 0.001 - 0.050 mg / L, Vitamin B6 in an amount of 0.01 - 0.10 mg / L, Vitamin B7 in an amount of 0.001 - 0.050 mg / L, Vitamin B12 in an amount of 0.01 - 0.50 mg / L, Vitamin C in an amount of 10 - 80 mg / L, Vitamin E in an amount of 0.001 - 0.050 mg / L, Vitamin K in an amount of 0.001 - 0.050 mg / L and the like; minerals and mineral salts selected from the group consisting of Calcium salt in an amount of 100 - 300 mg / L, Sodium salt in an amount of 5000 - 7000 mg / L, Potassium salt in an amount of 200 - 600 mg / L, Magnesium salt in an amount of 10 - 200 mg / L and the like, nucleic acids selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine in an amount of 1-50 mg / L and essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine in an amount of 2-150 mg / L.

[0106] In another embodiment, the pharmaceutical and dermatological acceptable excipients include but are not limited to diluents, carriers, buffering agents, colorants, humectants and the like in appropriate amount. Preferably, suitable carriers or diluents include but are not limited to distilled water, physiologic saline, bacteriostatic saline, (saline containing 0.9mg / ml benzyl alcohol).

[0107] The composition of the present invention exhibits synergistic effect of the growth factors, peptides and exosomes by preventing hair loss, promoting hair growth and preventing / reversing hair greying.

[0108] The composition of the present invention is effective in preventing hair loss by stimulating hair follicles and promoting hair growth, where such hair growth improves the bodily appearance of said person. It is also effective in preventing greying of hair and reversing the greying of hair by increasing melanin biosynthesis in hair follicles.

[0109] The pharmaceutical and dermatological hair growth composition of the present invention is used to prevent hair loss by stimulating hair follicles and promoting hair growth and prevent or reverse hair greying by increasing melanin biosynthesis in hair follicles and improve the bodily appearance of a person.

[0110] The composition of the present invention is stable and can be stored at room temperature (below 25°C). The composition of the present invention may also be packaged as prefilled syringes and as a hair filler. The prefilled syringe containing the composition is a ImL syringe with a needle of 31 gauge. The barrel of the syringe is marked with graduations, each syringe consisting of 40 such graduations and each graduation corresponding to one unit. One unit is equivalent to 0.025mL of the formulation.

[0111] The present invention disclose a hair filler insert embedded in hyaluronic acid enriched with present composition for enhanced delivery at the site of action.

[0112] The hair growth and anti-hair greying composition of the present invention may be administered to a subject in a manner which will result in an effective delivery of the amount or dose of the ingredients to the area where hair growth or reversal of hair greying is desired.

[0113] In another embodiment, the present invention discloses a method of preventing hair loss by stimulating hair follicles and promoting hair growth and improving the bodily appearance of a person comprising administering the pharmaceutical and dermatological hair growth and anti-hair greying composition in an effective amount to a person in need.

[0114] In another embodiment, the present invention provides a method for preventing greying of hair and reversing the greying of hair and improving the bodily appearance of a person comprising administering the pharmaceutical and dermatological hair growth and anti-hair greying composition of the present invention in an effective amount to a person in need.

[0115] Accordingly, the method of administration of said pharmaceutical and dermatological hair growth and anti -hair greying composition to a subject comprises:

[0116] a. cleaning the scalp of the subject with alcohol swab or surgical spirit; b. treating the affected area of the scalp with pharmaceutical and dermatological hair growth and anti-hair greying composition of the present invention in an effective stimulatory amount to treat or prevent alopecia and prevent or reverse hair greying.

[0117] The hair growth and anti-hair greying composition of the present invention may be administered intradermally or applied topically.

[0118] The composition is administered into the hair loss affected scalp through standard micro-needling techniques such as the nappage technique, through dermaroller application, hair filler inserts or topical application.

[0119] In another embodiment, the present invention discloses a device for administering the pharmaceutical and dermatological composition comprising a dermaroller, prefilled syringes, vials or hair filler inserts.

[0120] In yet another embodiment, the present invention discloses a kit comprising;

[0121] a) prefilled syringes or vials or a dermaroller comprising the pharmaceutical or dermatological composition or hair filler insert embedded in hyaluronic acid enriched with the present composition; and

[0122] b) instruction manual for application.

[0123] In another embodiment, the present composition can be co-administered with one or more hair growth promoting compounds selected from the group consisting of minoxidil, minoxidil analogs, minoxidil derivatives, anti-androgens and 5 alpha -reductase inhibitors. The one or more hair growth promoting compounds mentioned above may be co-administered in the form of oral, liquid or topical administration.

[0124] In another embodiment, the hair growth promoting compounds which are selected from the group consisting of minoxidil, minoxidil analogues, minoxidil derivatives, anti-androgens and 5-alpha- reductase inhibitors may be co-prescribed with the pharmaceutical composition. In an embodiment, the pharmaceutical and dermatological hair growth and anti¬ hair greying composition of the present invention may be formulated as intradermal, dermaroller and topical application.

[0125] In another embodiment, the present invention relates to a method of preventing hair greying thereby improving the bodily appearance of a person comprising administering to the scalp of subject a hair growth composition comprising Exosomes, Peptides, plurality of growth factors including their biomimetic analogues, Copper tripeptide 1, Noggin, Decapeptide- 10 (CG-Keramin2), Octapeptide-2 (Prohairin-β4), along with a nourishing complex of vitamins, minerals, amino acids, nucleic acids together with one or more pharmaceutically and dermatologically acceptable excipients in an amount effective to treat or to prevent hair loss by stimulating hair follicles and promoting hair growth and preventing hair greying by increasing melanin biosynthesis in hair follicles.

[0126] The alopecia that may be treated includes androgenetic alopecia, alopecia areata, female pattern baldness and secondary alopecia.

[0127] The method of treating alopecia and preventing hair greying and improving the bodily appearance of a person includes the step of introducing or applying an effective amount of hair growth composition into a subject once in 2 to 6 weeks, preferably about once in 3 weeks.

[0128] The pharmaceutical and dermatological hair growth and anti-hair greying composition of the present invention increases superficial cutaneous circulation in the subject thereby inhibiting the action of 5-a-reductase enzyme and thereby preventing hair loss by stimulating hair follicles and promoting hair growth.

[0129] In an embodiment, the composition of the present invention may be coadministered with one or more hair growth promoting compounds selected from the group consisting of minoxidil, minoxidil analogs, minoxidil derivatives and anti-androgens.

[0130] The hair growth and anti-hair greying composition of this invention may be used to stimulate hair growth in humans afflicted with androgenetic alopecia. Thus, these molecules may be administered in order to stimulate hair growth, thereby eliminating or reducing the severity of hair loss and / or the speed at which alopecia progresses. Other hair loss afflictions which can be treated include androgenetic alopecia, alopecia areata, female pattern baldness and secondary alopecia, and hair loss secondary to chemotherapy, radiation, post-COVID19 hair loss etc. (secondary alopecia). In the case of secondary alopecia, these may be used in advance of the hair loss insults such as chemotherapy or radiation regimens, to stimulate hair growth prior to the insults, thereby resulting in reduced amount of hair loss resulting therefrom. The pharmaceutical and dermatological composition increases superficial cutaneous circulation in the subject, inhibits action of 5-a-reductase enzyme and thereby prevents hair loss by stimulating hair follicles and promoting hair growth.

[0131] The hair growth and anti-hair greying composition of this invention may be used to prevent greying of hair and reverse grey hair in individuals by increasing melanin biosynthesis in hair follicles and elevating the mRNA expression levels of melanin synthesis factors.

[0132] The invention can be better understood by the following non-limiting examples. The examples given are mere an illustration of the instant invention and should not be construed as limiting the scope of the present invention in any manner.

[0133] Examples:

[0134] Example 1: Hair growth and Anti hair greying composition: Table 1: Hair growth and Anti-Hair greying composition

[0135] No

[0136] Ingredients Name Concentration (mg / L) Function

[0137] 1 Skin Protecting

[0138] 1 Caffeoyl Tripeptide- 1

[0139] HGF or its biomimetic 10 Antioxidant, Hair Conditioning, variant sh-Polypeptide Skin Conditioning

[0140] 2

[0141] 62

[0142] PDGFA (Platelet- 50 Humectant, Skin Conditioning Derived Growth Factor

[0143] A) or its biomimetic

[0144] 3

[0145] variant sh- Polypeptide-8 and / or

[0146] Sh-Polypeptide-59

[0147] SCF (Stem Cell 1 Antioxidant, Hair Conditioning, Factor) or its Skin Conditioning

[0148] 4 biomimetic variant sh- Polypeptide-4

[0149] SOD-1 (Superoxide 0.5 Skin Protecting

[0150] Dismutase 1) or its

[0151] 5

[0152] biomimetic variant sh- Polypeptide-60

[0153] Sirt-1 (Sirtuin 1) or its 0.1 Antioxidant, Hair Conditioning, 6 biomimetic variant sh- Skin Conditioning Polypeptide-66

[0154] Alanine / Histidine / Lysi 10 Skin Conditioning

[0155] 7 ne Polypeptide Copper

[0156] HCl [cu-AHK]

[0157]

[0158] Caffeoyl sh- 1 Skin Conditioning Decapeptide-9 [PhytoNEP]

[0159] Tetrapeptide-32 1 Hair Conditioning, Skin [ESP / Elastin Scalp Protecting Peptide]

[0160] Biotinoyl sh- 50 Skin Conditioning Oligopeptide-129 SP

[0161] [BIO-TDP]

[0162] Panax Ginseng 7.5 Skin Conditioning Adventitious Root

[0163] Extracellular Vesicles

[0164] Human Umbilical 100,000 Skin Conditioning Mesenchymal Stem

[0165] Cell Conditioned

[0166] Media

[0167] VEGFA (sh- Skin Conditioning

[0168] 5

[0169] Polypeptide-9)

[0170] bFGF (sh-Polypeptide- Skin Conditioning

[0171] 2

[0172] 1)

[0173] IGF-1 (sh- SKIN CONDITIONING, SKIN 2

[0174] Oligopeptide-2) PROTECTING KGF-1 (sh- 1 SKIN CONDITIONING Polypeptide-3)

[0175] TMB4 (sh- 0.01 SKIN CONDITIONING Oligopeptide-4)

[0176] Copper Tripeptide- 1 10 SKIN CONDITIONING Noggin or its 10 Skin Protecting

[0177]

[0178] biomimetic variant sh- Polypeptide-13

[0179] Decapeptide- 10 (CG- 10

[0180] Keramin2)

[0181] Octapeptide-2

[0182] 0.005

[0183] (Prohairin-P4)

[0184] 1,2-Hexanediol q.s Solvent

[0185] Antiplaque, Skin Conditioning, Water q.s

[0186] Solvent

[0187] Astringent, Viscosity Calcium Chloride 5.83 mg / L

[0188] Controlling

[0189] Copper Sulfate 0.000065mg / L Skin Conditioning

[0190] Ferric Nitrate 0.0025mg / L Not Reported

[0191] Ferric Sulfate 0.02mg / L Humectant

[0192] Potassium Chloride 15.59 mg / L Viscosity Controlling Magnesium Chloride 1.43 mg / L Viscosity Controlling Bulking, Hair Conditioning, Magnesium Sulfate 2.44 mg / L

[0193] Viscosity Controlling Bulking, Masking, Oral Care, Sodium Chloride 349.78 mg / L

[0194] Viscosity Controlling Abrasive, Buffering, Deodorant, Sodium Bicarbonate 60.00 mg / L

[0195] Oral Care, Skin Protecting Sodium Phosphate 3.13 mg / L Buffering

[0196] Anticorrosive, Buffering, Disodium Phosphate 3.55 mg / L

[0197] Masking

[0198] Antimicrobial, Antiplaque, Zinc Sulfate 0.02 mg / L

[0199] Astringent, Oral Care Glucose 157.55 mg / L Humectant

[0200]

[0201] Antistatic, Cleansing, Emollient, Linoleic Acid 0.0021mg / L Hair Conditioning, Skin Conditioning, Surfactant Thioctic Acid 0.01 mg / L Antioxidant

[0202] Sodium Pyruvate 2.75 mg / L Skin Conditioning Antistatic, Hair Conditioning, Alanine 0.22 mg / L

[0203] Masking, Skin Conditioning 7.38 mg / L Skin Conditioning Arginine HC1

[0204] Antistatic, Hair Conditioning, Asparagine 0.37 mg / L

[0205] Masking, Skin Conditioning Antistatic, Hair Conditioning, Aspartic Acid 0.33 mg / L

[0206] Masking, Skin Conditioning Antioxidant, Antistatic, Hair 0.88 mg / L Conditioning, Hair Waving Or Cysteine

[0207] Straightening, Masking, Reducing

[0208] 1.56 mg / L Antistatic, Hair Conditioning, Cystine

[0209] Masking

[0210] 0.37 mg / L Antistatic, Hair Conditioning, Glutamic Acid

[0211] Humectant

[0212] 13.25 mg / L Antistatic, Hair Conditioning, Glutamine

[0213] Skin Conditioning

[0214] 0.94 mg / L Antistatic, Buffering, Hair Glycine

[0215] Conditioning, Skin Conditioning 1.57 mg / L Hair Conditioning, Skin Histidine HC1

[0216] Conditioning

[0217] 2.72 mg / L Antistatic, Hair Conditioning, Isoleucine

[0218] Skin Conditioning

[0219] Leucine 2.95 mg / L Antistatic, Hair Conditioning,

[0220]

[0221] Skin Conditioning

[0222] 4.56 mg / L Hair Conditioning, Skin Lysine HC1

[0223] Conditioning

[0224] 0.86 mg / L Antistatic, Hair Conditioning, Methionine

[0225] Skin Conditioning

[0226] 1.77 mg / L Hair Conditioning, Masking, Phenylalanine

[0227] Skin Conditioning

[0228] 0.86 mg / L Hair Conditioning, Skin Proline

[0229] Conditioning

[0230] 1.31 mg / L Antistatic, Hair Conditioning, Serine

[0231] Masking, Skin Conditioning 2.67 mg / L Antistatic, Hair Conditioning, Threonine

[0232] Hair Waving Or Straightening 0.45 mg / L Antistatic, Hair Conditioning, Tryptophan

[0233] Masking

[0234] 2.79 mg / L Antistatic, Hair Conditioning, Tyrosine

[0235] Masking, Skin Conditioning 2.64 mg / L Antistatic, Hair Conditioning, Valine

[0236] Masking, Skin Conditioning Antiseborrhoeic, Hair Biotin 0.000175mg / L Conditioning, Skin Conditioning

[0237] 0.11 mg / L Antistatic, Hair Conditioning Calcium Pantothenate

[0238] 0.13 mg / L Skin Conditioning

[0239] Folic Acid

[0240]

[0241] 0.63 mg / L Antistatic, Hair Conditioning, 4 Inositol

[0242] Humectant

[0243] 0.10 mg / L Smoothing

[0244] 5 Niacinamide

[0245] 0.10 mg / L Antistatic, Hair Conditioning, 6 Pyridoxine HC1

[0246] Skin Conditioning

[0247] 0.01 mg / L Cosmetic Colorant, Skin 7 Riboflavin

[0248] Conditioning

[0249] 0.11 mg / L Masking, Skin Conditioning 8 Thiamine HC1

[0250] 0.02 mg / L Skin Conditioning

[0251] 9 Thymidine

[0252] 0.03 mg / L Skin Conditioning

[0253] 70 Cyanocobalamin

[0254] 400.00 mg / L Skin Conditioning

[0255] 71 Adenosine

[0256] 72 Ferric Nitrate 0.0025mg / L Humectant

[0257]

[0258] Table 2: Product Specification:

[0259] Test Item Specifications Test Result Judgement APPEARANCE transparent transparent suitability solution solution

[0260] COLOUR colorless colorless suitability Sense

[0261] Index ODOUR Characteristic Characteristic suitability odor odor

[0262]

[0263] Volume 5ml (>97%) 5.2ml suitability Aerobic Bacterial Max.100 cfu / g 0 cfu / g suitability Count

[0264] Yeast Mould Max.100 cfu / g 0 cfu / g suitability Microbiolo Count

[0265] gical Index

[0266] Pseudomonas Absence Absence suitability aeruginosa

[0267] Staphylococcus Absence Absence suitability aureus

[0268] Escherichia coli Absence Absence suitability Note on Avoid direct sunlight and store at room temperature.

[0269] storage

[0270]

[0271] Example 2: Preparation of the hair growth and anti-hair greying composition:

[0272] 1) The solvent i.e. water at a temperature of 25°C was added with the active ingredients and excipients of the composition (provided in Table 1) to the disperser;

[0273] 2) The disperser was set at 800 rpm for 30 minutes;

[0274] 3) The pH was adjusted and a 500 MESH micron filter system was used to filter the final product;

[0275] 4) This was followed by filling, closing and labeling of the vials.

[0276] Example 3: Assessment to determine improvement in hair loss Videomicroscopic photographs were carried out with a proscope digital hand-held camera, at a fixed position in the central area of the scalp from 15 and 20 cm posterior to the glabella. At each set position, images were taken to calculate hair counts per cm2. All videomicroscopic images were analyzed for difference in vellus hair count, terminal hair count, and hair shaft diameter, using specialized software.

[0277] Table 3: Videomicroscopic assessment showing vellus and terminal hair count (15 cm and 20 cm) and hair shaft diameter post-treatment

[0278] Mean at Mean at 4thMean at baseline Mean at 4thsession Mean at 8thsession

[0279] Vellus hair count at 15 51.14 40.65 40.98 -12.16*** cm

[0280] Vellus hair count at 20 43.68 46.32 41.85 -6.83** cm

[0281] Terminal hair count at 162.23 174.25 181.78 + 15.95*** 15 cm

[0282] Terminal hair count at 182.78 189.93 191.75 +8.07*** 20 cm

[0283] Hair shaft diameter at 28.65 27.21 33.12 +4.47* 15 cm (μm)

[0284] Hair shaft diameter at 27.54 31.89 34.15 +4.61* 20 cm (μm)

[0285] N

[0286]

[0287] ote: Paired t test. *p < 0.05, **p < 0.01, ***p < 0.001; δ1 – Mean at eight sessions – mean at baseline; δ2 – Mean at four sessions – mean at baseline.

[0288] Example 4:

[0289] A standardized photographic technique was used to take photo- graphs of frontal, vertex, and temporo-parietal areas of the scalp at baseline, fourth session, and eighth session. These were assessed by two blinded clinicians and graded on the scale 0-10, with 0 showing no growth and 10 indicating thick hair growth. The mean score was calculated and analyzed.

[0290] Table 4:

[0291] Reviewer Baseline 4th Session 8th Session Post 2 months after 8th session Reviewer 1 5 7.5 8 8

[0292]

[0293] Reviewer 2 5 7 7.5 8

[0294] Mean 5 7.25 7.75 8

[0295]

[0296] Example 5:

[0297] Patients filled a validated questionnaire at the end of fourth and eighth sessions comprising two sections. The first section had four questions related to the effectiveness of the treatment rated on a scale of 0-5, with 0 (strongly disagree) and 5 (strongly agree).

[0298] Results of patient self- assessment questionnaire related to the efficacy of the treatment on a scale of 1-5.

[0299] Table 5:

[0300] Category After 4 Sessions After 8 Sessions Growth of hair 3 4 Amount of noticeable new hair 2.5 4 Reduction in visibility of the

[0301] scalp 3 5 Rate of hair loss 3 4.5

[0302]

[0303] Example 6: Hair pull test:

[0304] To assess the improvement in hair loss was done with the hair pull test. A bundle of 50-60 hairs were grasped between thumb, index finger, and middle finger and pulled from the base near to the scalp. Pulled out hair was count. Results were evaluated at baseline, after fourth session and eighth session.

[0305] Example 7: Effect on melanin synthesis

[0306] The aim of this study was to evaluate the effect of the present composition on melanin synthesis and the expression of melanin production factors in B16F10 murine melanoma cells. Specifically, the study investigated whether the present composition enhanced melanin biosynthesis without causing cytotoxicity and increased mRNA levels of key melanin synthesis factors, thereby assessing its potential as a pigmenting agent. Preparation:

[0307] Murine melanoma cell line, B16F10 cells (ATCC, no. CRL-6475) maintained in DMEM medium (Dulbecco’s Modified Ealge’s Medium) containing 10% FBS (fetal bovine serum), penicillin (100 lU / ml), and streptomycin (100 pg / ml) at 37°C in a humidified, 5% CO2 atmosphere. The present composition was prepared in DMEM medium immediately before use.

[0308] Protocol:

[0309] 1. Evaluation of melanin contents

[0310] B16F10 cells were washed twice using DPBS (Dulbecco’s Phosphate-Buffered Saline) and collected by centrifugation. Cell number was determined by trypan blue and resuspended the cells in DMEM medium. The cell suspension was dispensed into the wells of the 6-well plate to a final concentration of 2 × 104cells / well. The present composition was added and a cultured medium was used as an untreated control. The plate was incubated at 37°C for 72 hours in a humidified, 5% CO₂ atmosphere. To measure the amount of intracellular melanin, the cultured cells were dissolved in 1 N NaOH containing 10% DMSO (dimethyl sulfoxide) at 60°C for 1 hour. Record the absorbance at 490 nm using a 96-well plate reader.

[0311] The percentage of relative melanin contents was calculated as follows:

[0312] Relative melanin contents (%) = (absorbance of treatment / absorbance of nontreatment) x 100

[0313] 2. Evaluation of mRNA levels for melanin production factors

[0314] B16F10 cells were washed twice using DPBS (Dulbecco’s Phosphate-Buffered Saline) and collected by centrifugation. Cell number was determined by trypan blue and resuspended the cells in DMEM medium. The cell suspension was dispensed into the wells of the 6-well plate to a final concentration of 2 x 104cells / well. The present composition was added and a cultured medium was used as an untreated control. The plate was incubated at 37°C for 24 hours in a humidified, 5% CO2 atmosphere. The total RNA was extracted using TRI-solution (BSK, Korea) according to the manufacturer’s instructions, and quantification by Take 3 microvolume plate (Agilent, USA). The complementary DNA was synthesized using PrimeScript Reverse Transcriptase (Takara, Japan). RT-PCR (reverse transcription polymerase chain reaction) was performed using a PCR thermocycler (Thermo Fisher Scientific, USA). The PCR products were examined after gel electrophoresis. Band images were quantified using Image J software. The percentage of relative mRNA level was calculated as follows:

[0315] Relative mRNA level (%) = (Band intensity of treatment group / Band intensity of non-treatment group) × 100

[0316] Results

[0317] - Effect of present composition on melanin synthesis:

[0318] The results showed that the present composition significantly increases melanin biosynthesis in B16F10 cells compared to the control by over 200% relative melanin content without causing cytotoxicity (as depicted in Figure 1). Therefore, present composition has an effect as a pigmenting agent.

[0319] - Effect of present composition on the mRNA levels of melanin synthesis factors The result indicated a notable elevation in the mRNA expression levels of melanin synthesis factors by 200% in tyrosinase, 475% in TRP1 and 675% in DCT expression following treatment with the present composition's depicted in figure 2). Therefore, present composition has an effect as a pigmenting agent.

[0320] Example 8: Effect of the present composition on the regulation of hair follicle cycle factors

[0321] The aim of this study was to evaluate the effect of the present composition on the regulation of hair follicle cycle factors in human hair follicle dermal papilla cells (HFDPC). Specifically, the study aimed to assess whether the present composition could inhibit hair loss and stimulate hair growth by analyzing changes in the mRNA levels of key regulatory factors, including DKK-1, SRD5A1, and P-catenin.

[0322] Preparation: Hair follicle dermal papilla cells (HFDPC) (Promo Cell, lot.

[0323] 485Z014.1) maintained in DMEM medium (Dulbecco’s Modified Ealge’s Medium) containing 10% FBS (fetal bovine serum), penicillin (100 IU / ml), and streptomycin (100 μg / ml) at 37°C in a humidified, 5% CO₂ atmosphere. The present composition was prepared in DMEM medium immediately before use. Protocol:

[0324] HFDPC were washed twice using DPBS (Dulbecco's Phosphate-Buffered Saline) and collected by centrifugation. Cell number was determined by trypan blue and resuspended the cells in DMEM medium. The cell suspension was dispensed into the wells of the 6-well plate to a final concentration of 2 × 104cells / well. The present composition was added and a cultured medium was used as an untreated control. The plate was incubated at 37°C for 24 hours in a humidified, 5% CO2 atmosphere. The total RNA was extracted using TRI-solution (BSK, Korea) according to the manufacturer’s instructions, and quantification by Take 3 microvolume plate (Agilent, USA). The complementary DNA was synthesized using PrimeScript Reverse Transcriptase (Takara, Japan). RT-PCR (reverse transcription polymerase chain reaction) was performed using a PCR thermocycler (Thermo Fisher Scientific, USA). The PCR products were examined after gel electrophoresis.

[0325] Quantification:

[0326] Band images were quantified using Image J software, and the percentage of relative mRNA level was calculated as follows:

[0327] Relative mRNA level (%) = (Band intensity of treatment group / Band intensity of non-treatment group) × 100

[0328] Result:

[0329] Effect of the present composition on inhibiting hair loss and stimulating hair growth:

[0330] The effects of the present composition on the mRNA levels of factors involved in regulating the hair follicle cycle were assessed. The treatment group showed a reduction in mRNA levels of DKK-1 by 55% and SRD5A1 by 65% compared to the control group, while an 125% increase in expression level of P-catenin was observed (as depicted in figure 3). These findings indicate that the use of present composition may have the potential to inhibit hair loss and promote hair growth.

Claims

We Claim;1. A pharmaceutical and dermatological hair growth and anti-hair greying composition comprising;i. Peptides selected from Caffeoyl Tripeptide-1 in an amount of 0.05mg / L to lOmg / L; Stem Cell Factor (SCF) including its biomimetic variant sh- Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh- Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75 mg / L; alone or mixtures thereof.ii. Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50000 mg / L to 100000 mg / L alone or mixtures thereof.iii. Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L;iv. Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh-Polypeptide-8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500 mg / L;along withv. Vascular endothelial growth factor (Human oligopeptide- 11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L;vi. Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of O. Olmg / L tolOO mg / L;vii. Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of O. Olmg / L to lOOmg / L; viii. Copper tripeptide 1 in an amount of O.lmg / L to 500 mg / L;ix. Keratinocyte growth factor including its biomimetic analogue Sh- Polypeptide-3 in an amount of O. Olmg / L to 100 mg / L;x. Thymosin P4 including its biomimetic analogue Sh-Oligopeptide-4 in an amount of 0.005mg / L to 100 mg / L;xi. Noggin including its biomimetic variant sh-Polypeptide-13in an amount of 9 to 11 mg / L;xii. Decapeptide- 10 (CG-Keramin2) in an amount of 8.5 to 10.5 mg / L; xiii. Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005 mg / L; xiv. Vitamins, minerals, nucleic acids and amino acids in appropriate concentrationand with pharmaceutical and dermatological acceptable ingredients and excipients.

2. The composition as claimed in claim 1, wherein the composition may comprise other peptides selected from Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide-11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; Oligopeptide-74 (CG-Grotene) in appropriate concentration and the like.

3. The composition as claimed in claim 1, wherein the vitamins are selected from the group consisting of Vitamin A in an amount of 0.01 to 0.50 mg / L, Vitamin Bl in an amount of 0.01 to 0.50 mg / L, Vitamin B2 in an amount of 0.01 to 0.50 mg / L, Vitamin B3 in an amount of 1.0 to 50 mg / L, Vitamin B5 in an amount of 0.001 to 0.050 mg / L, Vitamin B6 in an amount of 0.01 to 0.10 mg / L, Vitamin B7 in an amount of 0.001 to 0.050 mg / L, Vitamin B12in an amount of 0.01 to 0.50 mg / L, Vitamin C in an amount of 10 to 80 mg / L, Vitamin E in an amount of 0.001 to 0.050 mg / L, Vitamin K in an amount of 0.001 to 0.050 mg / L and the like.

4. The composition as claimed in in claim 1, wherein the minerals and mineral salts are selected from Calcium salt in an amount of 100 to 300 mg / L, Sodium salt in an amount of 5000 to 7000 mg / L, Potassium salt in an amount of 200 to 600 mg / L, Magnesium salt in an amount of 10 to 200 mg / L and the like.

5. The composition as claimed in in claim 1, wherein the nucleic acids are selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine in an amount of 1-50 mg / L; the essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine in an amount of 2-150 mg / L.

6. The composition as claimed in claim 1, wherein the pharmaceutically and dermatologically acceptable excipients include but are not limited to diluents, carriers, buffering agents, humectant, colorants and the like in appropriate concentration.

7. The composition as claimed in claim 1, wherein the composition may comprise the growth factors selected from the group consisting of follistatin, Wnt proteins, β catenin proteins, stem cell factor, and platelet derived growth factors in appropriate concentration.

8. The composition as claimed in claim 1, wherein the composition may comprise the compounds selected from the group consisting of minoxidil,minoxidil analogues, minoxidil derivatives, anti-androgens and 5-alpha- reductase inhibitors.

9. The composition as claimed in claim 1, wherein said composition may be formulated as intradermal or topical composition.

10. The composition as claimed in claim 1, wherein said composition may be formulated as ready-to-inject sterile glass vial, as powder-liquid composition in two separate glass vials, as prefilled syringes or combined with Hyaluronic Acid.

11. A pharmaceutical and dermatological hair growth and anti-hair greying composition prepared by the process comprising;i. Adding the Peptides selected from Caffeoyl Tripeptide- 1 in an amount of 0.05 mg / L to 10 mg / L; Stem Cell Factor (SCF) including its biomimetic variant sh-Polypeptide-4 in an amount of 0.05 mg / L to 15 mg / L; Caffeoyl sh-Decapeptide-9 in an amount of 0.05 mg / L to 10 mg / L; Tetrapeptide-32 in an amount of 0.05 mg / L to 15 mg / L; Superoxide Dismutase 1 (SOD-1) including its biomimetic variant sh-Polypeptide-60 in an amount of 0.05 mg / L to 15 mg / L; Sirtuin 1 (Sirt-1) including its biomimetic variant sh- Polypeptide-66 in an amount of 0.01 mg / L to 5 mg / L; Alanine / Histidine / Lysine Polypeptide Copper HCl [cu-AHK] in an amount of 0.5 mg / L to 50 mg / L; Biotinoyl sh-Oligopeptide-129 SP [BIO-TDP] in an amount of 10 mg / L to 75mg / L; Exosomes selected from Panax Ginseng Adventitious Root Extracellular Vesicles in an amount of 0.5 mg / L to 50 mg / L; Human Umbilical Mesenchymal Stem Cell Conditioned Media in an amount of 50,000mg / L to lOOOOOmg / L; Growth factors selected from Hepatocyte Growth Factor (HGF) including its biomimetic variant Sh- Polypeptide 62 in an amount of 0.5 mg / L to 50 mg / L; Platelet-Derived Growth Factor A (PDGFA) including its biomimetic variant Sh- Polypeptide-8 and / or Sh-Polypeptide-59 in an amount of 0.5 mg / L to 500mg / L; Vascular endothelial growth factor (Human oligopeptide- 11) including its biomimetic analogue Sh-Polypeptide-9 in an amount of 0.01mg / L – 100mg / L; Basic fibroblast growth factor (Human oligopeptide-3) including its biomimetic analogue Sh-Polypeptide-1 in an amount of 0.01 mg / L - 100 mg / L; Insulin like growth factor (Human oligopeptide-2) including its biomimetic analogue Sh-Oligopeptide-2 in an amount of 0.01mg / L – 100mg / L; Copper tripeptide 1 in an amount of 0.1mg / L – 500 mg / L; Keratinocyte growth factor including its biomimetic analogue Sh-Polypeptide-3 in an amount of O. Olmg / L - 100 mg / L; Thymosin β4 including its biomimetic analogue Sh-Oligopeptide-4 in an amount of 0.005mg / L - 100 mg / L; Noggin including its biomimetic variant sh-Polypeptide-13 in an amount of 9-llmg / L, Decapeptide- 10 (CG-Keramin2) in an amount of 8.5-10.5mg / L and Octapeptide-2 (Prohairin-β4) in an amount of 0.0025 to 0.005mg / L; vitamins, minerals, nucleic acids and amino acids in appropriate concentration; along with pharmaceutically and dermatologically acceptable excipients to distilled water at ambient temperature in the disperser set at 750-1000 rpm;ii. Adjusting the pH and filtering the final product followed by filling the vials.

12. The composition as claimed in claim 11, wherein the vitamins are selected from the group consisting of Vitamin A in an amount of 0.01 to 0.50 mg / L, Vitamin Bl in an amount of 0.01 to 0.50 mg / L, Vitamin B2 in an amount of 0.01 to 0.50 mg / L, Vitamin B3 in an amount of 1.0 to 50 mg / L, Vitamin B5 in an amount of 0.001 to 0.050 mg / L, Vitamin B6 in an amount of 0.01 to 0.10 mg / L, Vitamin B7 in an amount of 0.001 to 0.050 mg / L, Vitamin B12 in an amount of 0.01 to 0.50 mg / L, Vitamin C in an amount of 10 to 80 mg / L, Vitamin E in an amount of 0.001 to 0.050 mg / L, Vitamin K in an amount of 0.001 to 0.050 mg / L and the like.

13. The composition as claimed in in claim 11, wherein the minerals and mineral salts are selected from Calcium salt in an amount of 100 to 300 mg / L, Sodium salt in an amount of 5000 to 7000 mg / L, Potassium salt in an amount of 200 to 600 mg / L, Magnesium salt in an amount of 10 to 200 mg / L and the like.

14. The composition as claimed in in claim 11, wherein the nucleic acids are selected from the group consisting of Adenosine, Cytosine, Guanine and Thymine in an amount of 1-50 mg / L; the essential and non-essential amino acids selected from the group consisting of Taurine, Hydroxyproline, Methionine, Proline, Ornithine, Asparagine, Glutamic acid, Aspartic acid, Cystine, Serine, Glycine, Tyrosine, Phenylalanine, Isoleucine, Tryptophan, Threonine, Leucine, Histidine, Valine, Arginine, Lysine, Alanine and Glutamine in an amount of 2-150 mg / L.

15. The composition as claimed in claim 11, wherein the pharmaceutically and dermatologically acceptable excipients include but are not limited to diluents, carriers, buffering agents, humectant, colorants and the like in appropriate concentration.

16. The composition as claimed in claim 11, wherein the composition may comprise other peptides selected from Elastin scalp peptide (Tetrapetide 32) in the concentration of about 20ppm; Elastin Hair Peptide (Hexapeptide- 12) in the concentration of about 20ppm; Acetyl Tetrapetide-3 in appropriate concentration; Octapeptide-11 in appropriate concentration; Octapeptide-20 in appropriate concentration; Palmitoyl pentapeptide -3 in appropriate concentration; Oligopeptide-74 (CG-Grotene) in appropriate concentration and the like.

17. The composition as claimed in any one of the claims 1 to 16, wherein said composition is used to prevent hair loss by stimulating hair follicles and promoting hair growth and improving the bodily appearance of a person.

18. The composition as claimed in any one of the claims 1 to 16, wherein said composition is used to prevent or reverse hair greying by increasing melanin biosynthesis in hair follicles and elevating the mRNA expression levels of melanin synthesis factors.

19. A method of preventing hair loss by stimulating hair follicles and promoting hair growth and improving the bodily appearance of a person comprising administering the pharmaceutical and dermatological hair growth and anti¬ hair greying composition as claimed in any one of the claims 1 to 18 in an effective amount to a person in need.

20. A method for preventing greying of hair and reversing the greying of hair and improving the bodily appearance of a person comprising administering the pharmaceutical and dermatological hair growth and anti-hair greying composition as claimed in any one of the claims 1 to 18 in an effective amount to a person in need.

21. The method as claimed in claim 19 and 20, wherein said composition may be administered intradermally or applied topically.

22. The method as claimed in claim 21, wherein said composition may be administered through micro-needling techniques such as the nappage technique, through dermaroller, or hair filler inserts.

23. The method as claimed in claim 19 and 20, wherein one or more hair growth promoting compounds selected from the group consisting of minoxidil, minoxidil analogs, minoxidil derivatives, anti-androgens and 5-alpha-reductase inhibitors and such like may be co-administered with said hair growth and anti-hair greying composition.

24. The method as claimed in any one of the claims 19 to 23 comprising; a) Cleaning the scalp of the subject with alcohol swab or surgical spirit; b) Treating the affected area of the scalp with the pharmaceutical and dermatological composition in an effective stimulatory amount.

25. A device for administering the pharmaceutical and dermatological composition comprising a dermaroller, prefilled syringes, vials or hair filler inserts.

26. A kit comprising;a) prefilled syringes or vials or a dermaroller comprising the pharmaceutical or dermatological composition as claimed in claim 1 or hair filler insert embedded in hyaluronic acid enriched with composition of claim 1; andb) instruction manual for application.

Images