Hair care formulations

Abstract

Provided are hair care formulations that protect the hair follicles and scalp of a subject from negative effects of hair dyeing. The hair care formulations include an antioxidant, a melanin stimulant, an anti-irritation component, a sebum modulator, a scalp repair component, and an anti-inflammatory agent. Several of these components are derived from natural sources, such as extracts from the roots of the Ononis spinosa flower, from mandarin orange fruit, and from seeds of the Schinus terebinthifolia tree. The formulations also include peptides used for melanin stimulation and scalp repair. Also provided are kits containing the scalp protection formulation, along with methods of using the scalp protection formulation. Also provided are formulations supporting hair pigmentation, hair growth, hair length, and hair health.

Description

HAIR CARE FORMULATIONSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application 63 / 567,783, filed March 20, 2024, which is incorporated herein by reference.INTRODUCTION

[0002] Hair dye is one of the most commonly used chemicals in hair care. About 70% of women dye their hair with about 75% of those dyeing to cover grey (Gitnux, “Must- Know Hair Coloring Statistics”, 2004, gitnux.org / hair-coloring-statistics / ). The average frequency of hair dye usage for the purpose of covering grey hair is typically every 3-5 weeks.

[0003] However, the hair dyeing process, especially when repeated for years or decades, can cause significant damage to the hair follicles and the hair itself. Symptoms such as prematurely greying hair, hair thinning, scalp irritation and redness, coarseness, dryness and dullness have occurred.

[0004] The hair itself has an inner medulla layer surrounded by the cortex, which is then surrounded by an outermost layer called the cuticle. The natural color of hair is provided by melanin molecules located within the cortex. Temporary hair coloring merely involves applying coloring agents to the surface of the cuticle. This hair coloring is relatively simple, but the coloring agents typically begin to fade due to being washed off the surface.

[0005] To maintain the desired color for a longer period of time, the hair dyeing uses a “developer” composition. Typically, the developer composition includes an alkaline agent (e.g. ammonia or monoethanolamine) to cause the hair to swell, thereby allowing access to the inner cortex layer. The developer composition also includes hydrogen peroxide to oxidize the natural melanin in the cortex, thereby “bleaching” the hair and mostly removing its color. The developer composition also includes primary intermediates and coupling compounds, which are particular compounds chosen to give a particular “new” color to the hair. For instance, US 2003 / 0159221 describes paraphenylene-diamine compounds used as intermediates or coupling compounds for providing the new, desired hair color.

[0006] However, these hair dyeing chemicals cause many several different types of irritation and damage to the scalp and the hair follicle. When performed for years or decades, hair dyeing can noticeably reduce the quality of hair.

[0007] Specifically, the hydrogen peroxide in the hair developer is an oxidizing agent that generates reactive oxygen species (ROS) and other free radicals. These free radicals cause damage and signs of aging such as hair loss, hair thinning, depigmentation of the hair, and even cancer. Specifically, the “Sister Study” of 47,000 women found that there was a 9% higher incidence of breast cancer in women who regularly used permanent hair dye in the preceding year than women who did not use such products (United States National Institute of Environmental Health Sciences, “Permanent hair dye and straighteners may increase breast cancer risk”, January 2020, factor.niehs.nih.gov / 2020 / 1 / papers / hair-dye).

[0008] Not only does the current hair experience oxidative damage, but newly grown hair can also be damaged since oxidative stress is placed on the scalp and hair follicle as well.

[0009] Attempts have been made to reduce the damage to the hair strands themselves from the hair dyeing process. Also, some chemicals within the hair developer formulations have been substituted to reduce the damage.

[0010] However, there is an unmet need for a formulation that would protect the hair follicles and scalp from the negative effects of hair dyeing. Protecting the hair follicles would allow new hair that is grown in the future to maintain its thickness, smoothness, and vibrancy of natural color.SUMMARY

[0011] Provided are hair care formulations that protect the hair follicles and scalp of a subject from negative effects of hair dyeing. The hair care formulations include an antioxidant, a melanin stimulant, an anti-irritation component, a sebum modulator, a scalp repair component, and an anti-inflammatory agent. Several of these components are derived from natural sources, such as extracts from the roots of the Ononis spinosa flower, from mandarin orange fruit, and from seeds of the Schinus terebinthifolia tree. The formulations also include peptides used for melanin stimulation and scalp repair. Also provided are kits containing the scalp protection formulation, along with methods of using the scalp protection formulation. Also provided are formulations supporting hair pigmentation, hair growth, hair length, and hair health.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 represents analysis of clinical grading of erythema.

[0013] FIG. 2 represents analysis of clinical grading of edema.

[0014] FIG. 3 represents Self-Perception Questionnaire - Immediate.

[0015] FIG. 4 represents Self-Perception Questionnaire - Day 3.DETAILED DESCRIPTION

[0016] Provided are hair care formulations that protect the hair follicles and scalp of a subject from negative effects of hair dyeing. The hair care formulations include an antioxidant, a melanin stimulant, an anti-irritation component, a sebum modulator, a scalp repair component, and an anti-inflammatory agent. Several of these components are derived from natural sources, such as extracts from the roots of the Ononis spinosa flower, from mandarin orange fruit, and from seeds of the Schinus terebinthifolia tree. The formulations also include peptides used for melanin stimulation and scalp repair. Also provided are kits containing the scalp protection formulation, along with methods of using the scalp protection formulation. Also provided are formulations supporting hair pigmentation, hair growth, hair length, and hair health.

[0017] Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0018] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0019] Certain ranges are presented herein with numerical values being preceded by the term "about." The term "about" is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately aspecifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0020] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials may now be described. Any and all publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[0021] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any element, e.g., any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely”, “only” and the like in connection with the recitation of claim elements, or the use of a “negative” limitation.

[0022] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. To the extent the definition or usage of any term herein conflicts with a definition or usage of a term in an application or reference incorporated by reference herein, the instant application shall control.

[0023] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.FORMULATIONS

[0024] Provided is a formulation for protecting the hair follicles of a subject from negative effects of hair dyeing. Such formulations can also be referred to herein as “hairprotection formulations” and “hair follicle protection formulations”. The formulation comprises of: an antioxidant component comprising a Citrus reticulata fruit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising: pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof; an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

[0025] In some embodiments, the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

[0026] In some embodiments, the anti-inflammatory component comprises both an Avena strigosa seed extract and an Ononis spinosa root extract.

[0027] In some embodiments, the vehicle comprises water.

[0028] In some embodiments, the formulation described herein further comprises a Polygonum multiflorum root extract.

[0029] In some embodiments, the formulation described herein further comprises a Panax ginseng root extract.

[0030] In some embodiments, the formulation described herein further comprises acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

[0031] In some embodiments, the formulation described herein further comprises butylene glycol, pentylene glycol, glycerin, or a combination thereof.

[0032] Also provided are formulation for supporting hair pigmentation, hair growth, hair length, and hair health. In some cases the formulation includes: a hair growth component comprising: a Trifolium pratense (red clover) extract comprising Biochanin A; and acetyl tetrapeptide-3; an anti-hair loss and anti-hair graying component comprising:a Spirulina maxima extract comprising phycocyanins; and a Chlorella emersonii extract comprising xanthophylls; and a vehicle.

[0033] In some cases, the vehicle includes water, e.g. 90% or more of the vehicle is water.

[0034] In some cases the formulation further includes one or more of: an Ononis spinosa root extract; an Avena strigosa seed extract; a citrus reticulata (tangerine) extract; a Zanthoxylum bungeanum extract; a Humulus lupulus (hops) extract; a Sesamum indicum seed extract; a soybean germ extract; a Wasabia japonica leaf extract; a Panax ginseng root extract; a Rosmarinus officinalis (rosemary) leaf extract; a Serenoa serrulata fruit extract; and a coffea arabica seed extract.KITS

[0035] Provided is a kit for protecting the hair follicles of a subject from negative effects of hair dyeing. The kits comprise a hair protection formulation and a vehicle. The kit comprises of: a hair follicle protection formulation; and a packaging containing the hair follicle protection formulation, wherein the hair follicle protection formulation comprises: an antioxidant component comprising a Citrus reticulata fruit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising: pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof;an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

[0036] The vehicle of the formulation is the component that the other ingredients are dissolved or dispersed within. For example, if the formulation is a liquid, then the other ingredients can be dissolved in water, where the water is the vehicle. If the formulation is a solid powder, then the vehicle can be a diluting component such as cellulose.

[0037] In some embodiments, the kit further comprises instructions directing the subject to apply the hair follicle protection formulation to their scalp after dyeing their hair.

[0038] In some embodiments, the kit further comprises a hair bleaching composition comprising hydrogen peroxide.

[0039] In some embodiments, the kit further comprises a hair color composition.

[0040] In some embodiments, the hair color composition comprises a paraphenylenediamine compound.

[0041] In some embodiments, the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

[0042] In some embodiments, the anti-inflammatory component comprises both an Avena strigosa seed extract and an Ononis spinosa root extract.

[0043] In some embodiments, the vehicle comprises water.

[0044] In some embodiments, the hair follicle protection formulation further comprises a Polygonum multiflorum root extract.

[0045] In some embodiments, the hair follicle protection formulation further comprises a Panax ginseng root extract.

[0046] In some embodiments, the hair follicle protection formulation further comprises acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

[0047] In some embodiments, the hair follicle protection formulation further comprises butylene glycol, pentylene glycol, glycerin, or a combination thereof.

[0048] Also provided are kits that include the formulations for supporting hair pigmentation, hair growth, hair length, and hair health, as discussed above.METHODS

[0049] Provided is a method of protecting the hair follicles of a subject from negative effects of hair dyeing. The method comprises:applying a hair follicle protection formulation to the scalp, wherein the hair follicle protection formulation comprises: an antioxidant component comprising a Citrus reticulata fruit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising: pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof; an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

[0050] In some embodiments of the method, the application of the formulation is performed 8 hours or less after hair attached to the scalp was contacted with a hair bleaching composition, a hair color composition, or a combination thereof. In some cases, the applying is done within 6 hours, within 4 hours, within 2 hours, within 1 hour, within 30 minutes, within 15 minutes, or within 5 minutes.

[0051] In some cases, the applying is performed soon after the hair dye is rinsed from the hair, such as within 8 hours, 6 hours, 4 hours, 2 hours, 1 hour, 30 minutes, 15 minutes, or 5 minutes.

[0052] In some cases, the application of the hair protection formulation can be performed before the hair dyeing, instead of after the hair dyeing. For instance, the hair protection formulation can be performed 8 hours or less before the hair dyeing (i.e. before the scalp is contacted with a hair bleaching composition or a hair color composition), such as 6 hours or less before, 4 hours or less before, 2 hours or less before, 1 hour or less before, 30 minutes or less before, 15 minutes or less before, or 5 minutes or less before.

[0053] In some embodiments, the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

[0054] In some embodiments, the anti-inflammatory component comprises both an Avena strigosa seed extract and an Ononis spinosa root extract.

[0055] In some embodiments, the vehicle comprises water.

[0056] In some embodiments, the hair follicle protection formulation further comprises a Polygonum multiflorum root extract.

[0057] In some embodiments, the hair follicle protection formulation further comprises a Panax ginseng root extract.

[0058] In some embodiments, the hair follicle protection formulation further comprises acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

[0059] In some embodiments, the hair follicle protection formulation further comprises butylene glycol, pentylene glycol, glycerin, or a combination thereof.

[0060] Also provided are methods of supporting hair pigmentation, hair growth, hair length, and hair health, the method comprising: applying the formulations described for that purpose above to a section of scalp of the subject. The applying can occur in the evening, e.g. to promote and enhance natural circadian rhythms. In some cases, the applying occurs between 8pm and midnight in the time zone that the subject is located.EXAMPLES

[0061] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the present invention, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g. amounts, temperature, etc.) but some experimental errors and deviations should be accounted for.Example 1 : Evaluation of the efficacy of a scalp treatment post hair dye application.

[0062] Overview

[0063] Hair dyeing can cause irritation to the skin of the scalp, thereby causing erythema (i.e. redness) and edema (swelling due to excess fluid). Specifically, the chemicals used in hair dyeing, such as hydrogen peroxide, can cause these negative irritation effects.

[0064] The present study investigated whether a hair protection formulation would reduce the amount of erythema and edema after hair dyeing. The observations showed that there was a statistically significant decrease in both erythema (p < 0.01 ; see FIG. 1 ) that was caused by the hair proection formula, i.e. in contrast to the skin not treated with the formulation. Both the treated and untreated side of the scalp showed a statistically significant decrease in edema, but the improvement on the treated side was numericallysuperior to that on the treated side, but the difference did not reach statistical significance (see FIG. 2).

[0065] Efficacy of the treatments were evaluated at various time points after the hair dyeing step.

[0066] Subjects

[0067] Thirty male and female subjects were screened and enrolled into the study and30 subjects completed the study. A demographic summary table is presented below:

[0068] Table 1 :

[0069] The Fitzpatrick skin types is a numerical classification system for human skin color and was developed in 1975 by American dermatologist Thomas B. Fitzpatrick. Type I is the palest skin color and is commonly associated with green or blue eyes and fair or red hair. Type II slightly darker skin that is still overall fairly light colored, and is commonly associated with blue eyes. Type III is the medium darkness skin that is commonly associated with brown eyes and brown hair. The scale also includes Types IV, V, and VI with increasing dark brown skin color.

[0070] The “hair type” classifications are categories that are commonly known in the field of hair care. For instance, Papilla Haircare provides a discussion of hair types (“How to Determine Your Hair Type - A Complete Guide”, 2 May 2021 , papillahaircare. com / a- complete-hair-type-guide / #12_Types_Of_Hair). Type 1 hair is generally straight and lacks any major curls or wave patters, and generally looks sleek and shiny. Type 2 hair has more curves and is sometimes considered “wavy”. Type 3 has the most curvature and can be called “curly”. Type 4 has the most curvature and can be called “coiled” or “kinky”. Subtypes (e.g. 1 A versus 1 B) provide a more detailed breakdown of hair curvature amounts.

[0071] Thirty male and female subjects used formulation-1 and they were assessed for scalp irritation. Formulation-1 was prepared from materials such as Ononis Spinosa Root Extract (Agreynist); Tripeptide-79 (Cabelludin); Anetholea Anisata Leaf Extract (Reviscalp); Palmitoyl Tetrapeptide-20 Amide (Greyverse) (customer supplied); Aqua / Water (Melanogray); Zanthoxylum Bungeanum Fruit Extract (customer supplied); Humulus Lupulus (Hops) Extract (Gust. Supplied); Sesamum Indicum Seed Extract (customer supplied); Butylene Glycol (customer supplied); Wasabia Japonica Leaf Extract (customer supplied); Schinus Terebinthifolia Seed Extract (Wastar Pink Berry).

[0072] The composition of formulation-1 is mentioned in the table below. QSAD means - Quantum Sufficit Ad (Latin: As Much as Is Sufficient). Also, %W / W is the percentage by weight, i.e. the percentage by mass.

[0073] Table 2:

[0074] In some cases, the mass amounts of the various ingredients can fall within the following ranges:

[0075] Avena Strigosa Seed Extract : from 0.0001 % to 0.01 %

[0076] Ononis Spinosa Root Extract : from 0.0001 % to 0.01 %

[0077] Pentasodium Tetracarboxymethyl Palmitoyl Dipeptide-12: from 0.1% to 3%

[0078] Tripeptide-79: from 0.1% to 3%

[0079] Anetholea Anisata Leaf Extract: from 0.0001% to 0.01%

[0080] Palmitoyl Tetrapeptide-20 Amide: from 0.0001 % to 0.01 %

[0081] Citrus Reticulata Extract: from 0.0001% to 0.01 %

[0082] Zanthoxylum Bungeanum Fruit Extract: from 0.0001 % to 0.01%

[0083] Humulus Lupulus (Hops) Extract: from 0.0001% to 0.01%

[0084] Sesamum Indicum Seed Extract: from 0.0001% to 0.01%

[0085] Wasabia Japonica Leaf Extract: from 0.0001% to 0.01 %

[0086] Panax Ginseng Root Extract: from 0.0001% to 0.01 %

[0087] Polygonum Multiflorum (Fo-Ti) Root Extract : from 0.0001 % to 0.01%

[0088] In some cases, the amount of ingredients are:

[0089] palmitoyl tetrapeptide-20 amide or a salt thereof: from 0.0001% to 0.01 %

[0090] Schinus terebinthifolia seed extract: from 0.0001 % to 0.01 %

[0091] Clausena anisata leaf extract: from 0.0001 % to 0.01 %

[0092] Application Instructions

[0093] Shampooing and Conditioning1 . After dyeing hair, rinse hair color off hair and scalp thoroughly.2. Clinical grader evaluations and digital photos of each side of the scalp.3. Cleanse hair and scalp with shampoo.4. Rinse shampoo thoroughly.5. Apply conditioner to the midshaft and ends of the hair. Avoid applying any conditioner to the scalp.6. Rinse conditioner thoroughly.7. Comb hair off the face and detangle with a wide tooth comb.

[0094] Formulation-1 Application - Half Head, to right side (for on-site and at home application)1 . Squeeze pipette and fill with formulation-1 . This will fill about 3 / 4 of the pipette, this will be enough product to complete 2 sections.2. Starting in the center of the head, place the pipette on the scalp at the front hairline.3. Move the pipette squeezing gently from the front hairline to the nape of the neck.4. Repeat this step 2 inches below the starting part and again place the pipette on the scalp and work from the front to the back of the head, squeezing gently.5. Refill pipette with formulation-1.6. Repeat again in another section, 2 inches below the previous section. Half head application should be completed within 4-6 sections.7. Repeat until formulation-1 has been applied from the center part to the hair line by the ear.8. Once each section is complete, place the pipette back in the bottle.9. Use fingertips to thoroughly massage formulation-1 into the scalp for 2 minutes.10. Do Not Rinse formulation-1 .1 1 . Wait 10 minutes for the formulation-1 to absorb and penetrate.12. Clinical grader evaluations and digital photos of each side of the scalp.13. Subjects will complete Immediate Self-Perception Questionnaire (SPQ).14. Subject will blow dry their hair (both sides) 10 minutes after the application of formulation-1 is finished on one half of the head.15. At least 30 minutes (up to 40 minutes) after the last evaluation (40 minutes after application) clinical grader evaluations, and digital photos will be taken.

[0095] Study Procedure:

[0096] Baseline, Visit 1 : Potential participants were contacted via email or phone to inform them to shampoo / conditioner their hair the day / evening before the first (Baseline) visit and not to use a clarifying shampoo a week prior to the first (Baseline) visit. After the last hair washing no styling products were used.

[0097] At the first (Baseline) visit, potential subjects were provided with the Informed Consent and Photo Release Form (for ten subjects) to read and given the opportunity to ask questions about the study during the consent discussion. Once written Informed Consent and Photo Release were provided, a brief medical history was collected, concomitant medications were recorded, and eligibility criteria were reviewed. Subjects completed a Habits Questionnaire.

[0098] The clinical grader parted the subject’s hair and secured it, if necessary. Each side the subject’s scalp was evaluated for erythema, and edema. Erythema and edema were graded on a 0 to 3 scale with 0 being no erythema or edema present and 3 being the worst condition (severe erythema or edema). Subjects with a clinically graded scalp erythema score of 0 to 1 .0 and an edema score of 0 qualified for the study. The evaluator documented the area of irritation / erythema to evaluate at the other timepoints and for photographs to be taken. If there was no irritation present on either half of the scalp an area was chosen for photographs that was likely to have irritation from the hair dye, such as areas of grey hair, along the hairline or the part. Photographs were taken (for ten subjects) on the area designated by the evaluator on each side of the head.

[0099] A technician dyed the subject’s hair using the subject’s supplied hair dye according to the instructions supplied with the hair dye product. After the hair dyeing process was complete, the hair was rinsed of the hair dye. Immediate post dyeing clinical grading for scalp erythema and edema, and photos of each side of the head (in the same area as Baseline) were conducted. Note: if the subject had no irritation at Baseline and irritation was observed at a different area than the Baseline photo was taken, this new area was used for all assessments (clinical grading and photos, as applicable) for the remaining timepoints.

[0100] Next a technician washed the subject’s hair with the supplied shampoo, rinsed and then applied the conditioner. After rinsing the conditioner and combing the hair formulation-1 was applied to the scalp, specifically to the right side of the head. Ten minutes after application, the Immediate post shampooing, conditioning, and formulation- 1 application clinical grading for scalp erythema and edema, and photos of each side of the head were conducted and subjects completed an SPQ for the treated side of the head. The subject’s hair was blow dried and when dry and after at least 30 minutes (30 - 40 minutes or 40 - 50 minutes after formulation-1 application) the Immediate postformulation-1 application clinical grading and digital photos were taken for both sides of the head.

[0101] Next, subjects were issued the sponsor-supplied shampoo, conditioner, and formulation-1 along with instructions (written and verbal) to use the shampoo and conditioner once, followed by the formulation-1 , on Day 2 according to the instructions. Subjects also received a diary to record the one-time use of the shampoo, conditioner, and formulation-1 e on Day 2.

[0102] Subjects were instructed to follow all study instructions including washing and conditioning their hair and applying the formulation-1 to the right side of their scalp onDay 2, to return with the shampoo, conditioner, formulation-1 and usage diary to the Day 2 visit (Visit 2).

[0103] Day 2, At home (no visit): Subjects washed their hair on Day 2 with sponsor provided shampoo and followed with Smooth conditioner. They were instructed to ensure that the shampoo was applied to the scalp and massaged in for 2 minutes before rinsing. Formulation-1 was applied to the right side of the scalp following the same instructions as for on-site application.

[0104] Dav 3, Visit 2: Subjects returned on Day 3 for Visit 2. Study staff asked and documented any changes to subjects’ health or medication or adverse event. The diary, shampoo, conditioner, and formulation-1 were collected and assessed for compliance with instructions. Each side of the subject’s head was clinically graded for erythema and edema. Digital photographs were taken of both sides of the scalp of the same 10 subjects as Baseline using the study records to ensure the photo was taken of the same area. Subjects completed a Self-Perception Questionnaire. At the conclusion of this visit, the subject’s participation was considered complete. Subjects were compensated for their participation.

[0105] Results of Statistical Analysis:

[0106] The data for statistical analysis included: Clinical grading assessments for scalp erythema and edema at Baseline, Immediate post dye rinse, Immediate post shampoo + conditioner + formulation-1 application, immediate after hair is dried, and Day 3 on the right and left sides of the head.

[0107] Attributes and acceptability of formulation-1 was assessed via subjective responses to Self-Perception Questionnaire (SPQ) completed Immediately postformulation-1 application on Day 3 on the right and left sides of the head. Demographic information was collected and tabulated. Type of hair dye was collected and tabulated.

[0108] Clinical grading assessment data, Changes from Baseline were evaluated within-treatment using Wilcoxon Signed Rank Test. Changes from Baseline were calculated with pre-dyed hair assessment scores as Baseline compared to post dyeing scores to show the amount of irritation. Changes from Baseline using post dyeing scores were used as Baseline compared to post treatment timepoint scores to show changes in irritation. Between treatment analysis was conducted to compare the untreated to treated sides.

[0109] Habits questionnaire responses collected before treatment were tabulated.

[0110] The table below indicates the grades of erythema on untreated scalp.

[0111] Self-Perception Questionnaire responses were summarized specifying percent agreement for each SPQ statement (with Strongly Agree and Agree, as the top box scores). The significance of the responses was evaluated with Binomial Test.

[0112] Descriptive statistics (mean, standard deviation, N) and raw data were provided for all data.

[0113] All statistical tests of hypothesis employed a level of significance of 0.05 and no adjustments were made for the number of tests performed.

[0114] A formal sample size calculation was not required for this study. Enrolling an adequate number of subjects to complete with at least 30 subjects is considered sufficient to be able to make certain claims from the data collected.

[0115] The table below indicates the grades of erythema on untreated scalp.

[0116] Table 3:

[0117] ND = No Data

[0118] The table below indicates the grades of erythema on treated scalp.

[0119] Table 4:

[0120] ND = No Data

[0121] The tables below indicate clinical grading of erythema.

[0122] Table 5:

[0123] Table 6:

[0124] % Change is calculated from the mean changes from baseline / after rinsing.

[0125] Immediate, After Treatment (hair wet) is immediate post shampooing, conditioning, and formulation-1 application, with 10 minutes for formulation-1 absorption, hair wet.

[0126] Immediate, After Treatment (hair dry) is immediate post shampooing, conditioning, and formulation-1 application and 30 minutes after hair dried.

[0127] *Significant change from baseline / after rinsing.

[0128] The table below indicates the grades of edema on untreated scalp.

[0129] Table 7:

[0130] The table below indicates the grades of edema on treated scalp.

[0131] Table 8:

[0132] The table below indicates clinical grading of edema.

[0133] Table 9:

[0134] Table 10:

[0135] % Change is calculated from the mean changes from baseline / after rinsing.

[0136] Immediate, After Treatment (hair wet) is immediate post shampooing, conditioning, and formulation-1 application, with 10 minutes for formulation-1 absorption, hair wet.

[0137] Immediate, After Treatment (hair dry) is immediate post shampooing, conditioning, and formulation-1 application and 30 minutes after hair dried.

[0138] *Significant change from baseline / after rinsing.

[0139] The table below indicates erythema mean scores for high lift dye subjects.

[0140] Table 11 :

[0141] The table below indicates habits questionnaire.

[0142] Table 12:

[0143] 5. How frequently do you use hair color? (for example, every 2, 3, 4, 5, 6 weeks)

[0144] 7. What brand and type of hair dye do you use?

[0145] The table below indicates Self-Perception Questionnaire - Immediate:

[0146] Table 13:

[0147] The table below indicates Self-Perception Questionnaire - Day 3:

[0148] Table 14:

[0149] Conclusion:

[0150] FIG. 1 represents analysis of clinical grading of erythema. Analysis of clinical grading of erythema showed a statistically significant increase in erythema for both sides of the scalp after dyeing the hair. For the treated side of the head, after one application of formulation-1 , erythema statistically significantly decreased immediately after application (10 minutes after application while the hair was wet), immediately after drying the hair and on Day 3, following an additional application. Erythema scores of the untreated side of the scalp also showed a statistically significant decrease over the same timepoints, but those improvements were less notable than that on the treated side.

[0151] The erythema results for the seven subjects who used High-Lift dye were similar to the results for the overall group of subjects. On the untreated side of the scalp, Baseline erythema scores averaged 0.14, after rinsing averaged 1.14, after washing averaged 0.86, after drying averaged 0.71 , and at Day 3 average 0.36. On the treated side, Baseline erythema scores averaged 0, after rinsing averaged 1.21 , after washing averaged 0.93, after drying averaged 0.5, and Day 3 averaged 0.

[0152] Between treatment analysis showed erythema scores were statistically significantly better (p<0.01 ) for the treated side of the head when compared to the untreated side at two timepoints (after drying and Day 3). Subjects were more likely to improve immediately after the treatment, with 96.67% of subjects improving after treatment compared to 68.97% of subjects without the treatment.

[0153] FIG. 2 represents analysis of clinical grading of edema. A statistically significant increase in edema was observed on both sides of the scalp following dyeing the hair. The treated side of the scalp showed a statistically significant decrease in edema at the following timepoints: after washing / treatment, after drying the hair and at Day 3. Theuntreated side also showed a statistically significant decrease in edema, after the hair was dried and on Day 3. Although the improvement on the treated side was numerically superior to that on the untreated side at all timepoints, between treatment analysis of the scores for the two sides of the scalp, treated and untreated, showed no statistically significant differences.

[0154] Subjects completed Self-Perception Questionnaires immediately after the first treatment of formulation-1 and on Day 3 after an additional application on Day 2. Results of topbox analysis of responses showed statistically significant top box results (Strongly Agree and Agree) to the statements listed below.

[0155] Table 15:Example 2: Formulations for supporting hair pigmentation, hair growth, hair length, and hair health

[0156] A formulation was created that contained the ingredients as shown in the table below.

[0157] The CAS (Chemical Abstract Services) number for acetyl tetrapeptide-3 is 827306-88-7.

[0158] In some cases, the mass amounts of the various ingredients can fall within the following ranges:

[0159] Trifolium pratense (red clover) extract: 0.00005% to 0.0025%

[0160] Acetyl tetrapeptide-3: 0.00005% to 0.0025%

[0161] Spirulina maxima extract: 0.00002% to 0.0004%

[0162] Chlorella emersonii extract: 0.00002% to 0.0004%

[0163] Avena Strigosa Seed Extract : from 0.0001 % to 0.01%

[0164] Ononis Spinosa Root Extract : from 0.0001 % to 0.01%

[0165] Palmitoyl Tetrapeptide-20 Amide: from 0.0001 % to 0.01 %

[0166] Citrus Reticulata Extract: from 0.0001% to 0.01 %

[0167] Zanthoxylum Bungeanum Fruit Extract: from 0.0001 % to 0.01%

[0168] Humulus Lupulus (Hops) Extract: from 0.0001% to 0.01%

[0169] Sesamum Indicum Seed Extract: from 0.0001% to 0.01%

[0170] Wasabia Japonica Leaf Extract: from 0.0001% to 0.01%

[0171] Panax Ginseng Root Extract: from 0.0001% to 0.01 %

[0172] In some cases, a first source formulation is used as a source of Trifolium pratense (red clover) extract and acetyl tetrapeptide-3.

[0173] Thus, in some cases the concentration of acetyl tetrapeptide-3 ranges from 0.00002% to 0.00175%. In some cases the concentration of red clover extract ranges from 0.00002% to 0.0015%.

[0174] In some cases, a second source formulation can be used as a source of Spirulina maxima extract and Chlorella emersonii extract.

[0175] In some cases, the amount of Spirulina maxima extract in the overall formulation ranges from 0.00012% to 0.0024%. In some cases, the amount of Chlorella emersonii extract in the overall formulation ranges from 0.01 1% to 0.22%.

[0176] Such formulations can be used to support pigment production, make a longer hair growth cycle, improve hair density, and combat stressors such as oxidative stressor DHT (dihydrotestosterone). Such formulations can also inhibit cortisol and enhance melatonin, wherein the densidyl component can specifically target cortisol and melatonin receptors. For example, such formulations can be applied in the evening, e.g. before sleep, to help regulate and promote circadian rhythms.

[0177] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0178] Accordingly, the preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0179] The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. In the claims, 35 U.S.C. §1 12(f) is expressly defined as being invoked for a limitation in the claim only when the exact

Claims

phrase "means for" or the exact phrase "step for" is recited at the beginning of such limitation in the claim; if such exact phrase is not used in a limitation in the claim, then 35 U.S.C. § 112(f) is not invoked.CLAIMSWhat Is Claimed Is:1 . A formulation for protecting the hair follicles of a subject from negative effects of hair dyeing, the formulation comprising: an antioxidant component comprising a Citrus reticulata uit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising: pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof; an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

2. The formulation of claim 1 , wherein the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

3. The formulation of claim 1 , wherein the anti-inflammatory component comprises both an Avena strigosa seed extract and an Ononis spinosa root extract.

4. The formulation of claim 1 , wherein the vehicle comprises water.

5. The formulation of claims 1 -4, further comprising a Polygonum multiflorum root extract.

6. The formulation of claims 1 -5, further comprising a Panax ginseng root extract.

7. The formulation of claims 1 -6, further comprising acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

8. The formulation of claims 1 -7, further comprising butylene glycol, pentylene glycol, glycerin, or a combination thereof.

9. A kit for protecting the hair follicles of a subject from negative effects of hair dyeing, the kit comprising: a hair follicle protection formulation; and a packaging containing the hair follicle protection formulation, wherein the hair follicle protection formulation comprises: an antioxidant component comprising a Citrus reticulata fruit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising: pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof; an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

10. The kit of claim 9, further comprising instructions directing the subject to apply the hair follicle protection formulation to their scalp after dyeing their hair.11 .The kit of claims 9-10, further comprising a hair bleaching composition comprising hydrogen peroxide.

12. The kit of claims 9-11 , further comprising a hair color composition.

13. The kit of claim 12, wherein the hair color composition comprises a paraphenylenediamine compound.

14. The kit of any one of claims 9-13, wherein the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

15. The kit of any one of claims 9-14, wherein the anti-inflammatory component comprises both an Avena strigosa seed extract and an Ononis spinosa root extract.

16. The kit of any one of claims 9-15, wherein the vehicle comprises water.

17. The kit of any one of claims 9-16, wherein the hair follicle protection formulation further comprises a Polygonum multiflorum root extract.

18. The kit of any one of claims 9-17, wherein the hair follicle protection formulation further comprises a Panax ginseng root extract.

19. The kit of any one of claims 9-18, wherein the hair follicle protection formulation further comprises acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

20. The kit of any one of claims 9-19, wherein the hair follicle protection formulation further comprises butylene glycol, pentylene glycol, glycerin, or a combination thereof.21 .A method of protecting the hair follicles of a subject from negative effects of hair dyeing, the method comprising: applying a hair follicle protection formulation to the scalp, wherein the hair follicle protection formulation comprises: an antioxidant component comprising a Citrus reticulata fruit extract; a melanin stimulation component comprising palmitoyl tetrapeptide-20 amide or a salt thereof; an anti-irritation component comprising a Schinus terebinthifolia seed extract; a sebum modulation component comprising a Clausena anisata leaf extract; a scalp repair component comprising:pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof, tripeptide-79 or a salt thereof, or a combination thereof; an anti-inflammatory component comprising: an Avena strigosa seed extract, an Ononis spinosa root extract, or a combination thereof; and a vehicle.

22. The method of claim 21 , wherein the application of the formulation is performed 8 hours or less after hair attached to the scalp was contacted with a hair bleaching composition, a hair color composition, or a combination thereof.

23. The method of claim 21 , wherein the application of the formulation is performed 8 hours or less before hair attached to the scalp was contacted with a hair bleaching composition, a hair color composition, or a combination thereof.

24. The method of any one of claims 21 -23, wherein the scalp repair component comprises both pentasodium tetracarboxymethyl palmitoyl dipeptide-12 or a salt thereof and tripeptide-79.

25. The method of any one of claims 21 -24, wherein the anti-inflammatory component comprises both an A vena strigosa seed extract and an Ononis spinosa root extract.

26. The method of any one of claims 21 -25, wherein the vehicle comprises water.

27. The method of any one of claims 21 -26, wherein the hair follicle protection formulation further comprises a Poiygonum multiflorum root extract.

28. The method of any one of claims 21 -27, wherein the hair follicle protection formulation further comprises a Panax ginseng root extract.

29. The method of any one of claims 21 -28, wherein the hair follicle protection formulation further comprises acetyl tyrosine, gluconolactone, sodium benzoate, or a combination thereof.

30. The method of any one of claims 21 -29, wherein the hair follicle protection formulation further comprises butylene glycol, pentylene glycol, glycerin, or a combination thereof.31 . A formulation for supporting hair pigmentation, hair growth, hair length, and hair health, the formation comprising: a hair growth component comprising: a Trifolium pratense (red clover) extract comprising Biochanin A; and acetyl tetrapeptide-3; an anti-hair loss and anti-hair graying component comprising: a Spirulina maxima extract comprising phycocyanins; and a Chlorella emersonii extract comprising xanthophylls; and a vehicle.

32. The formulation of claim 31 , wherein the vehicle comprises water.

33. The formulation of claim 31 or 32, further comprising one or more extracts selected from the group consisting of: an Ononis spinosa root extract; an Avena strigosa seed extract; a citrus reticulata (tangerine) extract; a Zanthoxylum bungeanum extract; a Humulus lupulus (hops) extract; a Sesamum indicum seed extract; a soybean germ extract; a Wasabia japonica leaf extract; a Panax ginseng root extract; a Rosmarinus officinalis (rosemary) leaf extract; a Serenoa serrulata fruit extract; and a coffea arabica seed extract.

34. The formulation of any one of claims 31 -33, further comprising biotin.

35. A kit for supporting hair pigmentation, hair growth, hair length, and hair health, the kit comprising: a formulation according to any one of claims 31 -34; and packaging containing the formulation.

36. A method of supporting hair pigmentation, hair growth, hair length, and hair health, the method comprising: applying a formulation according to any one of claims 31-34 to a section of scalp of a subject.

37. The method of claim 36, wherein the applying occurs between 8pm and midnight.

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