System and method for hair regrowth

Abstract

A method for promoting hair regrowth in a subject includes performing microneedling on a region of a scalp of the subject to a depth of 0.5 millimeters (mm) to 1.5 mm, applying at least one therapeutic agent to the microneedled region, wherein the at least one therapeutic agent comprises Minoxidil, Finasteride, and Dutasteride, and implanting non-permanent pigment particles into a superficial dermis of the microneedled region, the microneedling, the applying, and the implanting together synergistically stimulating hair follicle activity.

Description

ATTORNEY DOCKET NO. 0810-001-WOSYSTEM AND METHOD FOR HAIR REGROWTHCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 680,185 filed August 7, 2024, entitled “Pigments: A New Paradigm in Hair Growth,” the entire contents of which are incorporated herein by reference.BACKGROUND

[0002] Androgenetic alopecia (AGA) is the most common form of hair loss worldwide, but Food and Drug Administration (FDA)-approved treatments such as topical minoxidil and oral finasteride have limitations. Their slow onset of action and variable efficacy often lead to patient frustration and poor adherence.SUMMARY

[0003] The present disclosure is directed to a system and method for hair regrowth via microneedling, transdermal delivery of therapeutic agents, and scalp micropigmentation with nonpermanent pigments. The method accelerates hair regrowth and yields thicker, more resilient strands. The method is also known as Tournieux Hair Microstimulation (TxHM).

[0004] In one example, a method for promoting hair regrowth in a subject includes performing microneedling on a region of a scalp of the subject to a depth of 0.5 millimeters (mm) to 1.5 mm, applying at least one therapeutic agent to the microneedled region, wherein the at least one therapeutic agent comprises Minoxidil, Finasteride, and Dutasteride, and implanting nonpermanent pigment particles into a superficial dermis of the microneedled region, the microneedling, the applying, and the implanting together synergistically stimulating hair follicle activity.

[0005] In another example, a system for treating hair loss includes a microneedling device configured to create controlled punctures at a treatment site on a scalp at adjustable depths between 0.5 millimeters (mm) and 1.5 mm, a formulation comprising at least one therapeutic agent selected from the group consisting of Minoxidil, Finasteride, and Dutasteride, and a pigment formulation comprising non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm, the microneedling device adapted to deliver the therapeutic agent and the pigment formulation sequentially or simultaneously to the treatment site.ATTORNEY DOCKET NO. 0810-001-WQ

[0006] In another example, a kit for performing hair regrowth stimulation includes a singleuse microneedling cartridge or pen, a liquid therapeutic serum comprising at least one of Minoxidil, Finasteride, and Dutasteride, and a non-permanent pigment suspension, the single-use microneedling cartridge or pen adapted to deliver the liquid therapeutic serum and the non- permanent pigment suspension sequentially or simultaneously to a treatment site configured for application to a scalp to promote follicular activation.

[0007] These and other aspects, features, and benefits of the present disclosure will become apparent from the following detailed written description of the preferred embodiments and aspects taken in conjunction with the following drawings, although variations and modifications thereto may be effected without departing from the spirit and scope of the novel concepts of the disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings illustrate embodiments and / or aspects of the disclosure and, together with the written description, serve to explain the principles of the disclosure. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like elements of an embodiment, and wherein:

[0009] Figure 1 is a diagram of a treatment protocol including session sequence, healing timeline, and maintenance according to an example of the instant disclosure.

[0010] Figure 2 is a hair treatment landscape diagram according to an example of the instant disclosure.

[0011] Figures 3A-3D are schematics of scalp sections that show pre-treatment and posttreatment according to an example of the instant disclosure.

[0012] Figure 4 is a block diagram of a system for hair regrowth via microneedling, transdermal delivery of therapeutic agents, and scalp micropigmentation with non-permanent pigments according to an example of the instant disclosure.

[0013] Figure 5 is a flowchart of a method for hair regrowth via microneedling, transdermal delivery of therapeutic agents, and scalp micropigmentation with non-permanent pigments according to an example of the instant disclosure.DETAILED DESCRIPTION

[0014] The present disclosure is more fully described below with reference to the accompanying figures. The following description is exemplary in that several embodiments areATTORNEY DOCKET NO. 0810-001-WQ described (e.g., by use of the terms “preferably,” “for example,” or “in one embodiment”); however, such should not be viewed as limiting or as setting forth the only embodiments of the present disclosure, as the disclosure encompasses other embodiments not specifically recited in this description, including alternatives, modifications, and equivalents within the spirit and scope of the invention. Further, the use of the terms “invention,” “present invention,” “embodiment,” and similar terms throughout the description are used broadly and not intended to mean that the invention requires, or is limited to, any particular aspect being described or that such description is the only manner in which the invention may be made or used. Additionally, the invention may be described in the context of specific applications; however, the invention may be used in a variety of applications not specifically described.

[0015] The embodiment(s) described, and references in the specification to “one embodiment”, “an embodiment”, “an example embodiment”, etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic. Such phrases are not necessarily referring to the same embodiment. When a particular feature, structure, or characteristic is described in connection with an embodiment, persons skilled in the art may effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

[0016] In the several figures, like reference numerals may be used for like elements having like functions even in different drawings. The embodiments described, and their detailed construction and elements, are merely provided to assist in a comprehensive understanding of the invention. Thus, it is apparent that the present invention can be carried out in a variety of ways, and does not require any of the specific features described herein. Also, well-known functions or constructions are not described in detail since they would obscure the invention with unnecessary detail. Any signal arrows in the drawings / figures should be considered only as exemplary, and not limiting, unless otherwise specifically noted. Further, the description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.

[0017] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Purely as a non-limiting example, a first element could be termed a second element, and, similarly, a second element could be termed a firstATTORNEY DOCKET NO. 0810-001-WO element, without departing from the scope of example embodiments. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms "a", "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be noted that, in some alternative implementations, the functions and / or acts noted may occur out of the order as represented in at least one of the several figures. Purely as a non-limiting example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending upon the functionality and / or acts described or depicted.

[0018] Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment.

[0019] Traditional treatments for androgenetic alopecia (AGA), such as minoxidil and finasteride, are widely used but often have limitations, including slow onset of action and variable efficacy among individuals. Many patients may experience frustration from extended treatment periods resulting in minimal visible results.

[0020] Microneedling has gained traction as a promising hair-restoration technique due to its ability to release growth factors Transforming Growth Factor (TGF)-beta, TGF-alpha, Fibroblast Growth Factor (FGF)-7, and Platelet-Derived Growth Factor (PDGF), and activate healing mechanisms. Microneedling promotes hair-follicle development and cycling by enhancing collagen and elastin production and improving vascularization. Microneedling also creates microchannels that allow transdermal drug delivery. Numerous studies confirm the positive therapeutic effects of microneedling, especially in conjunction with medications for androgenetic alopecia (AGA).

[0021] Pigmentation techniques were first documented as an artistic tattoo for camouflaging hairless areas. In addition, pigmentation has been used as an adjunct in scalp cosmetic surgery. Since 2011, scalp micropigmentation (SMP) has emerged as a refined medical-tattooing processATTORNEY DOCKET NO. 0810-001-WQ in which pigment is inserted into the skin to augment hair transplants, mainly in cases of insufficient donor hair supply. SMP serves as a permanent concealer with established parameters for achieving consistent results. Factors have been identified for effective pigment application, including needle angle, penetration depth, exposure time, rotor speed, pigment viscosity, and operator expertise.

[0022] Notable case studies have shown successful outcomes when SMP is combined with hair transplants. However, the potential role of pigments in stimulating hair growth remains underexplored. This raises the question of whether the pigments used in SMP might influence hair regeneration when combined with microneedling and drug delivery. Research on pigment delivery to the scalp as a hair growth stimulant is limited. An intriguing discussion remains: do hair follicles grow over tattoos?

[0023] In 2023, there was a case of a 56-year-old woman with alopecia universalis who, despite high compliance with medical therapy, experienced no lasting hair regrowth. However, immediately after receiving an artistic tattoo, she had complete scalp hair regrowth. The mechanism by which the hair growth occurred is undetermined, and it is unknown if the tattoo ink or tattooing process contributed to the growth. While no evidence confirmed that tattooing stimulates hair follicle growth, this patient's case represents an unusual response, prompting further study for similar occurrences. No similar occurrences were found except case reports of allergic reactions to henna tattoos, leading to temporary hypertrichosis.

[0024] Following up on observations, there was a proposal that tattoo-induced hair regrowth might be explained by stimulating hair follicles to transition to the anagen phase through the wound healing process of microneedling, alongside the potential immunomodulatory and antioxidant effects of some tattoo ink constituents.

[0025] This present document reports the findings when combining microneedling and drug delivery with SMP using non-permanent mineral and organic pigments, which promote the regrowth of dormant hair, achieving fast hair growth with stronger and more resilient strands, ultimately enhancing patient satisfaction. This new procedure is referred to as TxHM

[0026] Study Population of the Observational Case Series

[0027] This study included all patients who underwent hair treatment with written informed consent. Exclusion criteria included bleeding disorders, active scalp infections, psoriasis / lichen planus (due to Koebner risk), pregnancy / lactation, scalp tumors, or major systemic diseases.ATTORNEY DOCKET NO. 0810-001-WQAesthetic evaluation included at least two sessions with photographic documentation and survey responses. Patients on systemic hair growth medications who had started treatment within twelve months or with inadequate photographic documentation were excluded from aesthetic analysis but included for safety and demographic data. Post-hair transplant patients were considered only if treatment started at least eighteen months after surgery. A full scalp exam was performed to confirm alopecia diagnoses.

[0028] Standardized photographs (consistent positioning and lighting) were taken before each session. Pain management options included vibration, topical lidocaine / tetracaine, or xylocaine infiltration. Microneedling used a pen device (e.g., Rotative Neon Pen Slim TH PRO, Switzerland) with a 27-needle cartridge (0.30 mm diameter), set to 1.2 mm depth, moved in circular passes. The device was charged with a solution of minoxidil 8%, finasteride 0.5%, growth factors (VEGF, IGF), D-panthenol, combined with organic / mineral pigments, adjusted per patient response. Pinpoint bleeding was the desired endpoint and sessions lasted thirty minutes. Post-procedure, plasma was left on the scalp for a “PRP-like” effect. Patients resumed normal activities, avoiding strenuous exercise for twenty-four hours, and were instructed to apply the same topical solution, twice daily for five days, then once daily. The protocol included six sessions including monthly sessions for three months, then quarterly sessions for nine months, and then maintenance every six months.

[0029] Assessment

[0030] The Modified Global Photographic Assessment (MGPA) using a 5-point scale (much worse, worse, same, better, or greatly improved) evaluated outcomes using six-position scalp photographs, within one year, at the intervals: baseline (TO), Tl, T2, T5, T8 and TH; followed by a maintenance phase twice a year. Changes were rated. Pain (0-10 scale), satisfaction, and side effects were monitored.

[0031] During the initial period, patients underwent microneedling with drug delivery via a tattoo machine (also known as MMP), either with or without pigments. After superior results using pigments, an alternative protocol without pigments was discontinued. Throughout the study, all participants received adjunctive topical minoxidil / finas teride.

[0032] This study evaluated nearly 1000 procedures performed on 230 patients over a period of time. Of these, 166 were included in aesthetic analysis. 64 were excluded due to recent hair transplant / medication use (n=30), inadequate photo / documentation (n=13), or single-sessionATTORNEY DOCKET NO. 0810-001-WQ participation (n=21). Patients were 86.1% male (n=198, mean age 46) and 13.9% female (n=32, mean age 51). AGA was diagnosed in 99.1% (n=228), with 63.1% of men at Norwood-Hamilton IV+ and 65.6% of women at Ludwig II-III. 2 patients (0.9%) had frontal fibrosing alopecia (FFA).

[0033] Pain management included vibration (70%), topical anesthesia (25%), or infiltration (5%), with a mean pain score of 4.5 (range 0-8). Procedures increased yearly: 157 (first year), 322 (second year), 566 (third year), and 947 (fourth year), with 51.6-60.2% of patients returning annually. The mean number of sessions per patient was 4.1. 28 patients reached maintenance (>7 sessions), with the longest treatment duration being 3 years, 9 months (12 sessions).

[0034] Side effects included forehead / eye swelling (5.2%, n=12, all post-infiltration), severe pain (0.4%, n=l, treatment abandoned), headache (2.2%, n=5), hair darkening (6.1%, n=14), burning from topical medication (84.8%, n=195), shedding post-first session (6.1%, n=14), later shedding (3.0%, n=7), and persistent scabbing (0.9%, n=2).

[0035] Aesthetic outcomes (5-point MGPA scale) were assessed by the patient, the author, and two blinded observers for 166 patients. 42% showed great improvement (score 5), 41% showed slight improvement (score 4), 16% showed no change (score 3), and 1% were worse (score 2). However, the system and method (n=153) outperformed MMP (n=13), with 44% vs. 23% scoring great improvement and 40% vs. 48% light improvement. Overall, 84% of the system and method group rated their outcomes positively (good to very good), while 71% of the MMP group reported favorable results.

[0036] Table 1 below shows an aesthetic evaluation of the system related cases.

[0037] Table 2 below shows an aesthetic evaluation of the MMP related cases.ATTORNEY DOCKET NO. 0810-001-WO

[0038] Statistics Analysis

[0039] The non-parametric Mann-Whitney test was used to compare the treatments. It was chosen as the results were non-normally distributed for the 5-point ordinal scale. The Shapiro- Wilks test was used to verify the normality of the data (p-values <0.001)

[0040] A significant difference was observed between the method and MMP treatments (Mann-Whitney test; p-value = 0.002). The method was significantly better.

[0041] Patients rated outcomes more positively than professionals. Both FFA patients showed no aesthetic change, though one reported reduced hair loss.

[0042] Table 3 below shows statistics analysis.

[0043] Androgenetic alopecia (AGA) remains a challenge in dermatology, with FDA- approved treatments like oral finasteride and topical minoxidil offering variable efficacy and compliance issues. This document discusses a system and method, a novel approach that combines microneedling, drug delivery, and scalp micropigmentation (SMP) with special pigments,ATTORNEY DOCKET NO. 0810-001-WO demonstrating superior aesthetic hair growth outcomes compared to microneedling with drug delivery alone (MMP). In this discussion, the method is compared against standard therapies, and pigment contributions are explored,

[0044] Response Rates of FDA- Approved Treatments

[0045] FDA-approved AGA therapies have well-documented efficacy. It was demonstrated in 1998 that oral finasteride (1 mg / day) slowed the progression of hair loss and increased hair growth in clinical trials over two years. Long-term studies, like a ten-year follow-up report sustained improvement in 21% of patients, peaking at one year, with better vertex than frontal results. Another study demonstrated that topical minoxidil 5% solution boosts hair regrowth even better than 2%, though a high percentage of patients may not respond due to low sulfotransferase activity. Moreover, patients using monotherapy continue to go bald despite therapy. Combination therapy (oral finasteride 1 mg + topical minoxidil 5%) according to a systematic review and meta-analysis, yields hair loss reduction and density increase, outperforming monotherapies. However, slow onset (six to twelve months), shedding, and side effects such as sexual dysfunction with finasteride, dermatitis and hypertrichosis with minoxidil hinder compliance, often leading to discontinuation within months.

[0046] Non-FD A- Approved Options and Microneedling

[0047] Emerging treatments like low-dose oral minoxidil (0.25-5 mg / day) and topical finasteride (0.25%) show promise with fewer systemic effects. Topical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations, and combination topical finasteride / minoxidil enhances hair density more than minoxidil alone. Microneedling with drug delivery improves hair density across studies. The mean change in hair count has been significantly greater for the microneedling and 5% Minoxidil lotion group compared to the 5% Minoxidil-only group, leveraging wound healing and enhanced drug absorption.

[0048] Ultimately, it is essential to recognize the need for FDA evaluation and approval of microneedling, oral minoxidil, and topical finasteride for hair loss treatment, as multiple studies have demonstrated their efficacy over conventional therapies. However, rapid efficacy remains elusive.ATTORNEY DOCKET NO. 0810-001-WQ

[0049] The system and method is based on a study of 230 patients and nearly 1000 procedures, and the system and method outperforms MMP aesthetically, with 44% of patients achieving “great improvement” (MGPA score 5) versus 23% with MMP (p=0.002, Mann-Whitney test). The system and method integrates microneedling (1.2 mm depth), minoxidil / finasteride delivery, and non-permanent organic / mineral pigments, yielding faster hair regrowth (one to three months) than standard treatments (six to twelve months). Patients report thicker, resilient strands and frontal regrowth — typically resistant to clinical therapies — enhancing natural outcomes, especially posthair transplant. Compliance exceeds 50% annually, contrasting with topical minoxidil’s early dropout rates, likely due to rapid, visible results within one to three months.

[0050] In telogen effluvium, the system and method arrests hair loss in one to two sessions, mirroring microneedling’s efficacy. For hair transplant candidates, the system and method improves follicular unit quality, optimizes procedure, accelerates regrowth (before three months post-operation), and reduces all areas’ thinning, complementing the cosmetic role of surgery. Patient satisfaction is high, with 84% of patients rating their outcomes positively compared to 71 % for MMP — a rate similar to that reported in the literature. Notably, patients consistently award higher scores than professionals, reflecting the influence of subjective expectations versus standardized assessments.

[0051] Adverse Effects and Safety

[0052] Side effects — swelling (5.2%), shedding (6.1%), hair darkening (6.1%), and burning(84.8%) — are transient, resolving without intervention. No severe events occurred in patients nor in maintenance patients (up to three years, nine months), suggesting a favorable long-term safety profile akin to microneedling studies. Compared to finasteride’s sexual dysfunction or minoxidil’s dermatitis, the adverse events are less disruptive, supporting higher compliance.

[0053] The Role of Pigments

[0054] Pigments emerged as a key differentiator after anecdotal observations: a 60-year-old woman with radiotherapy-induced alopecia regrew hair post-SMP, and patients reported hair darkening (6.1%) unrelated to scalp pigmentation. Initially a cosmetic adjunct, SMP’s therapeutic potential prompted its integration with minoxidil / finasteride as a diluent. Literature offers clues: tattoo-induced wound healing may shift follicles to anagen, as seen in a case of regrowth in alopecia universalis post-tattooing. Organic / mineral pigments (e.g., iron oxides, titanium dioxide) may exert immunomodulatory or antioxidant effects, while nanoparticle granulometry (<100 nm)ATTORNEY DOCKET NO. 0810-001-WQ could enhance bioactivity. In the method, pigments amplify drug delivery or directly stimulate follicles, though not all formulations work equally. Specific blends optimized results, warranting chemical analysis.

[0055] Tattooing deposits pigments 1.5-2 mm into the dermis, triggering inflammation, immune responses, and collagen repair. Microneedling’s shallower depth (e.g., 0.8-1.2mm) synergizes with pigments and drugs, potentially amplifying growth factor release (e.g., TGF-P, PDGF) and follicular activation. Unlike previous nonconclusive findings, the system provides consistent regrowth patterns across AGA patients suggesting a pigment-mediated effect beyond chance.

[0056] Pigment Chemistry and Challenges

[0057] Tattoo inks comprise 10-60% pigments (organic dyes or inorganic minerals), plus stabilizers, dispersants, and other vehicles. The Color Index classifies colorants (e.g., CI 77000- 77999 for inorganics, and CI 76999 and lower for organics), but exact compositions vary, complicating safety assessments. Nanoparticles increase reactivity, yet toxicity studies are sparse, and manufacturers rarely disclose full formulas.

[0058] Pigments are diluted with medications, potentially mitigating risks. While preliminary observations suggest a positive bioactive effect — whether through localized inflammation, antioxidant action, or synergistic interaction with the drugs. This indicates specific organic / mineral blends outperform others, highlighting the need for standardized pigment-associated drugs profiling.

[0059] The system and method provide solutions in hair restoration — particularly for patients seeking faster results, post-transplant enhancements, or non-invasive alternatives to traditional treatments.

[0060] The system provides a comprehensive hair regrowth system that integrates controlled microneedling, topical / transdermal delivery of active pharmaceutical ingredients (e.g., Minoxidil, Finasteride, Dutasteride, Cetirizine, and Latanoprost, among others), and topical / transdermal delivery of non-permanent organic or mineral pigments into the superficial dermis that aid follicular activation. The protocol enhances bioavailability, shortens onset time, and improves adherence and satisfaction.

[0061] This document relates to a method and system for treating hair loss, particularly androgenetic alopecia, by combining microneedling, transdermal drug delivery, and scalpATTORNEY DOCKET NO. 0810-001-WQ micropigmentation with non-permanent pigments. The system provides a synergistic effect that enhances follicular stimulation, accelerates therapeutic response, and improves patient satisfaction.

[0062] The method comprises three integrated components including controlled microneedling of the scalp, topical or transdermal application of therapeutic agents, and topical or transdermal application of non-permanent pigments into the superficial dermis.

[0063] This technique is designed to enhance the penetration and efficacy of topical drugs, mechanically stimulate hair follicles, and accelerate hair regrowth. The method may be performed manually or using a powered microneedling device with interchangeable cartridges.

[0064] Microneedling Protocol

[0065] Microneedling is performed using a device fitted with sterile single-use needle cartridges. The needle configuration may be linear (e.g., 12-39 needles) or stamp-type. Needle lengths are adjustable, typically ranging from 0.5 mm to 1.5 mm, depending on the patient's scalp condition and hair density.

[0066] In most embodiments, the procedure targets the upper dermis at a depth of approximately 0.5 to 1.2 mm, sufficient to stimulate follicular units without inducing excessive bleeding.

[0067] Treatment is performed in multiple passes with moderate pressure and perpendicular or oblique penetration. Each treated area receives a uniform and overlapping coverage to ensure even diffusion of the applied compounds.

[0068] Microneedling creates controlled micro-injuries that initiate wound healing cascades and growth factor release, including Platelet-derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), and Epidermal Growth Factor (EGF). Microneedling also enhances skin permeability for topical agents.

[0069] Therapeutic Agents

[0070] Following or during microneedling, one or more active compounds are applied to the scalp. These agents may include: Minoxidil (2-8% concentration), a vasodilator promoting anagen phase entry, Finasteride or Dutasteride (0.05-0.5%), a 5-alpha-reductase inhibitor reducing DHT levels locally, and other agents, such as Cetirizine, Eatanoprost, caffeine, and ketoconazole, among others.ATTORNEY DOCKET NO. 0810-001-WQ

[0071] The formulations may be water-based, ethanol-based, or liposomal to improve dermal absorption. Application may occur before, during, or after microneedling, with enhanced uptake due to trans-epidermal channels.

[0072] Pigment Application

[0073] The third component involves the implantation of non-permanent pigments into the upper dermis (approximately 0.5 to 1.5 mm depth), using either the same microneedling device or a separate cosmetic tattooing instrument. The pigments create potential biological stimulation through dermal interaction with pigment particles.

[0074] Pigment composition includes inorganic compounds (Metal oxides and Salts): e.g., iron oxides, titanium dioxide, and organic colorants: such as azo dyes, carbon black (cosmetic grade) - Organic (Synthetic Organic Pigments). Particle sizes generally range from 200 nanometers (nm) to 5,000 nm, allowing for suspension in liquid carriers and integration into skin tissue. Pigments are selected for their non-permanence, and can be color-matched to the patient’s hair and scalp tone.

[0075] Treatment Schedule

[0076] The full protocol may include six sessions including monthly sessions for three months, and then quarterly sessions for nine months. A post-procedure protocol includes minoxidil 8%, finasteride or dutasteride 0.3% and other therapeutical agents (e.g., Cetirizine, Latanoprost, caffeine, and ketoconazole, among others) applied twice daily for seven days, and then once daily. Maintenance may include one session every six to twelve months, depending on regrowth status. Post-care may include avoiding washing hair for twelve hours and sun exposure for twenty-four to seventy-two hours post-procedure.

[0077] Pigments may be applied prior, during, or after the drug application. Devices may include integrated cooling, vacuum suction, or automated depth control. The system and method may also be applied to other regions of the body such as beards, eyebrows, and post-transplant areas, among others.

[0078] Safety and Biocompatibility

[0079] The pigments and active agents used are dermatologically tested and certified for intradermal use. Adverse reactions are rare and typically limited to transient erythema, burning, or pruritus.ATTORNEY DOCKET NO. 0810-001-WQ

[0080] Figure 1 is a diagram of a treatment protocol 100 including session sequence, healing timeline, and maintenance according to an example of the instant disclosure. In one example, a patient may take a specialized test to tailor a treatment for the patient based on a genetic profile of the patient, enhancing both efficacy and speed of results. The treatment may include six sessions or another number of sessions that may last approximately thirty minutes and may include daily application of a topical solution. In addition, the treatment protocol 100 may include post treatment maintenance such as one session per year.

[0081] Figure 2 is a hair treatment landscape diagram 200 according to an example of the instant disclosure. As shown in Figure 2, there are a number of conventional solutions including minimally invasive options including topical solutions / pills. These typically have slow and muted results, leading to low patient adherence. There may be potential side effects (especially when taken orally). There are also other non-surgical alternatives including Platelet-rich plasma (PRP), stem cell, and exosome options. These are less effective and more invasive. Local anesthesia may be needed, there may be deeper intrusions into the scalp, there may be blood drawing, and there may be injections. There are also highly invasive options including hair transplant surgery. This may include transplanting hair from the back of the head. This may be suitable for men with advanced hair loss. It typically has a high cost such as $10,000 to $15,000 per session. There may be heavy side effects such as noticeable linear scarring. There is a limited quantity, e.g., there is a maximum of 9,000 units that can be extracted without causing visible scarring or thinning. In addition, there is a long recovery period and a post-transplant maintenance plan.

[0082] However, as shown in Figure 2, the system and method discussed herein provide a best non-surgical solution. The method may be based on microneedling, drug delivery, and nonpermanent scalp micropigmentation. This may provide regrowth of dormant hair follicles, thicker and healthier hair, fast results (in as little as eight weeks), no downtime, no anesthesia, no drawing of blood, and no injections, among other benefits.

[0083] Figures 3A-3D are schematics of scalp sections that show pre-treatment and posttreatment according to an example of the instant disclosure. Figure 3A shows example photographs 302 of pre-treatment and post-treatment for an example patient or subject. Figure 3B shows example photographs 304 of pre-treatment and post-treatment for another example patient or subject. Figure 3C shows example photographs 306 of pre-treatment and post-treatment forATTORNEY DOCKET NO. 0810-001-WQ another example patient or subject. Figure 3D shows example photographs 308 of pre-treatment and post-treatment for another example patient or subject.

[0084] Figure 4 is a block diagram of a system 400 for hair regrowth via microneedling, transdermal delivery of therapeutic agents, and scalp micropigmentation with non-permanent pigments according to an example of the instant disclosure. As shown in Figure 4, the system 400 may be a system for treating hair loss and may include a microneedling device 402. The microneedling device 402 may be configured to create controlled punctures in a scalp at adjustable depths between 0.6mm and 1.5mm. The system 400 may further include a formulation 404. The formulation 404 may be at least one therapeutic agent selected from the group consisting of Minoxidil, Finasteride, or Dutasteride. In addition, the system 400 may further include a pigment formulation 406. The pigment formulation may be non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm. The microneedling device 402 may be adapted to deliver the therapeutic agent 404 and pigment formulation 406 sequentially or simultaneously to a treatment site, e.g., the scalp.

[0085] As an example, the microneedling device 402 may include a reservoir for simultaneous infusion of therapeutic agent and pigment. In another example, the pigment formulation is sterile, dermatologically tested, and pH-adjusted for scalp application.

[0086] In another example, the system 400 may be a kit for performing hair regrowth stimulation. The kit may include a single -use microneedling cartridge or pen 402, a liquid therapeutic serum 404 containing Minoxidil or Finasteride / Dutas teride, and a non-permanent pigment suspension 406, wherein the kit is configured for application to a scalp to promote follicular activation. In one example, wherein the therapeutic serum includes both minoxidil and finasteride / dutasteride at different concentrations.

[0087] Figure 5 shows an example method 500 of hair regrowth via microneedling, transdermal delivery of therapeutic agents, and scalp micropigmentation with non-permanent pigments according to an example of the instant disclosure. Although the example method 500 depicts a particular sequence of operations, the sequence may be altered without departing from the scope of the present disclosure. For example, some of the operations depicted may be performed in parallel or in a different sequence that does not materially affect the function of the method 500. In other examples, different components of an example device or system thatATTORNEY DOCKET NO. 0810-001-WO implements the method may perform functions at substantially the same time or in a specific sequence.

[0088] According to some examples, the method 500 may include performing microneedling 510 on a region of a subject’s scalp to a depth of between 0.5 mm and 1.5 mm.

[0089] According to some examples, the method 500 may include applying 520 one or more therapeutic agents to the microneedled region, wherein the therapeutic agents include at least one of Minoxidil, Finasteride, or Dutasteride.

[0090] According to some examples, the method 500 may include implanting 530 nonpermanent pigment particles into the superficial dermis of the microneedled region. A combination of microneedling, therapeutic agent delivery, and pigment implantation synergistically stimulates hair follicle activity. As an example, the pigment is selected from iron oxide, titanium dioxide, or carbon black.

[0091] According to some examples, the method 500 may include performing the microneedling using an electrically powered pen with adjustable needle depth.

[0092] In another example, the method 500 may include applying the therapeutic agent immediately after microneedling and the therapeutic agent diffuses transdermally via microchannels.

[0093] According to some examples, the microneedling 510, the applying 520, and the implanting 530 may be a session. The method 500 may include repeating the session every fourteen to thirty days for at least three sessions.

[0094] As an example, the system may include a tattoo machine having a number of needle cartridges (e.g., thirty-nine) or with another type of machine or microneedling machine.

[0095] As another example, the system could be used with beards, eyebrows, or post-transplant zones. The system could be used approximately sixty days after a transplant. Patients may have three sessions that may be spaced apart from thirty to ninety days. As a result, transplanted follicles could be boosted for regrowth in order to promote reactivation of dormant follicles.

[0096] As an example, a pigment composition includes Inorganic(Metal oxides and Salts): Iron Oxides, Titanium Dioxide, and Organic(Synthetic Organic Pigments): Chlorinated Copper, Phthalocyanine, Anthraquinone, Azo Condensate, Benzimidazolone, Diketopyrrolopyrrole (DPP), Quinacridones.ATTORNEY DOCKET NO. 0810-001-WQ

[0097] The invention is not limited to the particular embodiments illustrated in the drawings and described above in detail. Those skilled in the art will recognize that other arrangements could be devised. The invention encompasses every possible combination of the various features of each embodiment disclosed. One or more of the elements described herein with respect to various embodiments can be implemented in a more separated or integrated manner than explicitly described, or even removed or rendered as inoperable in certain cases, as is useful in accordance with a particular application. While the invention has been described with reference to specific illustrative embodiments, modifications and variations of the invention may be constructed without departing from the spirit and scope of the invention as set forth in the following claims.

[0098] Illustrative examples of the disclosure include:

[0099] Aspect 1: A method for promoting hair regrowth in a subject, comprising performing microneedling on a region of a scalp of the subject to a depth of between 0.5 millimeters (mm) and 1.5 mm, applying at least one therapeutic agent to the microneedled region, wherein the at least one therapeutic agent comprises Minoxidil, Finasteride, and Dutasteride, and implanting nonpermanent pigment particles into a superficial dermis of the microneedled region, the microneedling, the therapeutic agent delivery, and the non-permanent pigment particles together synergistically stimulating hair follicle activity.

[0100] Aspect 2: The method of Aspect 1, wherein the microneedling is performed using an electrically powered pen with adjustable needle depth.

[0101] Aspect 3: The method of Aspects 1 and 2, wherein the electrically powered pen comprises a reservoir for simultaneous infusion of the at least one therapeutic agent and the non- permanent pigment particles.

[0102] Aspect 4: The method of Aspects 1 to 3, wherein the at least one therapeutic agent is applied immediately after microneedling and diffuses transdermally via microchannels.

[0103] Aspect 5: The method of Aspects 1 to 4, wherein the non-permanent pigment particles comprise a pigment that is at least one of iron oxide, titanium dioxide, and carbon black.

[0104] Aspect 6: The method of Aspects 1 to 5, wherein the microneedling, the applying, and the implanting together comprises a session, the method further comprising repeating the session every fourteen to sixty days for at least three sessions.ATTORNEY DOCKET NO. 0810-001-WO

[0105] Aspect 7: The method of Aspects 1 to 6, wherein the non-permanent pigment particles comprise non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm.

[0106] Aspect 8: The method of Aspects 1 to 7, wherein the non-permanent pigment particles are sterile, dermatologically tested, and pH-adjusted for scalp application.

[0107] Aspect 9: A system for treating hair loss, comprising a microneedling device configured to create controlled punctures at a treatment site on a scalp at adjustable depths between 0.5 millimeters (mm) and 1.5 mm, a formulation comprising at least one therapeutic agent selected from the group consisting of Minoxidil, Finasteride, and Dutasteride, and a pigment formulation comprising non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm, the microneedling device adapted to deliver the therapeutic agent and the pigment formulation sequentially or simultaneously to the treatment site.

[0108] Aspect 10: The system of Aspect 9, wherein the microneedling device comprises an electrically powered pen with adjustable needle depth.

[0109] Aspect 11: The system of Aspects 9 and 10, wherein the microneedling device comprises a reservoir for simultaneous infusion of the at least one therapeutic agent and the pigment formulation.

[0110] Aspect 12: The system of Aspects 9 to 11, wherein the at least one therapeutic agent is applied immediately after microneedling and diffuses transdermally via microchannels.

[0111] Aspect 13: The system of Aspects 9 to 12, wherein the non-permanent pigments comprise at least one of iron oxide, titanium dioxide, and carbon black.

[0112] Aspect 14: The system of Aspects 9 to 13, wherein the pigment formulation comprises non-permanent pigments selected from organic or inorganic particles sized between 200 nm and 5000 nm.

[0113] Aspect 15: The system of Aspects 9 to 14, wherein the pigment formulation is sterile, dermatologically tested, and pH-adjusted for scalp application.

[0114] Aspect 16: A kit for performing hair regrowth stimulation, comprising a single -use microneedling cartridge or pen, a liquid therapeutic serum comprising at least one of Minoxidil, Finasteride, and Dutasteride, and a non-permanent pigment suspension, the single-use microneedling cartridge or pen adapted to deliver the liquid therapeutic serum and the non-ATTORNEY DOCKET NO. 0810-001-WQ permanent pigment suspension sequentially or simultaneously to a treatment site configured for application to a scalp to promote follicular activation.

[0115] Aspect 17: The kit of Aspect 16, wherein the single -use microneedling cartridge or pen is electrically powered with an adjustable needle depth.

[0116] Aspect 18: The kit of Aspects 16 and 17, wherein the single -use microneedling cartridge or pen comprises a reservoir for simultaneous infusion of the liquid therapeutic serum and the non-permanent pigment suspension.

[0117] Aspect 19: The kit of Aspects 16 to 18, wherein the liquid therapeutic serum is applied immediately after microneedling and diffuses transdermally via microchannels.

[0118] Aspect 20: The kit of Aspects 16 to 19, wherein the non-permanent pigment suspension comprises at least one of iron oxide, titanium dioxide, and carbon black.

Claims

ATTORNEY DOCKET NO. 0810-001-WQCLAIMSWhat is claimed is:

1. A method for promoting hair regrowth in a subject, comprising: performing microneedling on a region of a scalp of the subject to a depth of 0.5 millimeters (mm) to 1.5 mm; applying at least one therapeutic agent to the microneedled region, wherein the at least one therapeutic agent comprises Minoxidil, Finasteride, and Dutasteride; and implanting non-permanent pigment particles into a superficial dermis of the microneedled region, the microneedling, the applying, and the implanting together synergistically stimulating hair follicle activity.

2. The method of claim 1 , wherein the microneedling is performed using an electrically powered pen with adjustable needle depth.

3. The method of claim 2, wherein the electrically powered pen comprises a reservoir for simultaneous infusion of the at least one therapeutic agent and the non-permanent pigment particles.

4. The method of claim 1, wherein the at least one therapeutic agent is applied immediately after microneedling and diffuses transdermally via microchannels.

5. The method of claim 1, wherein the non-permanent pigment particles comprise a pigment that is at least one of iron oxide, titanium dioxide, and carbon black.

6. The method of claim 1, wherein the microneedling, the applying, and the implanting together comprises a session, the method further comprising repeating the session every fourteen to sixty days for at least three sessions.ATTORNEY DOCKET NO. 0810-001-WQ7. The method of claim 1, wherein the non-permanent pigment particles comprise non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm.

8. The method of claim 1, wherein the non-permanent pigment particles are sterile, dermatologically tested, and pH-adjusted for scalp application.

9. A system for treating hair loss, comprising: a microneedling device configured to create controlled punctures at a treatment site on a scalp at adjustable depths between 0.5 millimeters (mm) and 1.5 mm; a formulation comprising at least one therapeutic agent selected from the group consisting of Minoxidil, Finasteride, and Dutasteride; and a pigment formulation comprising non-permanent pigments selected from organic or inorganic particles sized between 200 nanometers (nm) and 5000 nm, the microneedling device adapted to deliver the therapeutic agent and the pigment formulation sequentially or simultaneously to the treatment site.

10. The system of claim 9, wherein the microneedling device comprises an electrically powered pen with adjustable needle depth.

11. The system of claim 10, wherein the microneedling device comprises a reservoir for simultaneous infusion of the at least one therapeutic agent and the pigment formulation.

12. The system of claim 9, wherein the at least one therapeutic agent is applied immediately after microneedling and diffuses transdermally via microchannels.

13. The system of claim 9, wherein the non-permanent pigments comprise at least one of iron oxide, titanium dioxide, and carbon black.ATTORNEY DOCKET NO. 0810-001-WQ14. The system of claim 9, wherein the pigment formulation comprises nonpermanent pigments selected from organic or inorganic particles sized between 200 nm and 5000 nm.

15. The system of claim 9, wherein the pigment formulation is sterile, dermatologically tested, and pH-adjusted for scalp application.

16. A kit for performing hair regrowth stimulation, comprising: a single-use microneedling cartridge or pen; a liquid therapeutic serum comprising at least one of Minoxidil, Finasteride, and Dutas teride; and a non-permanent pigment suspension, the single -use microneedling cartridge or pen adapted to deliver the liquid therapeutic serum and the non-permanent pigment suspension sequentially or simultaneously to a treatment site configured for application to a scalp to promote follicular activation.

17. The kit of claim 16, wherein the single-use microneedling cartridge or pen is electrically powered with an adjustable needle depth.

18. The kit of claim 17, wherein the single-use microneedling cartridge or pen comprises a reservoir for simultaneous infusion of the liquid therapeutic serum and the non- permanent pigment suspension.

19. The kit of claim 16, wherein the liquid therapeutic serum is applied immediately after microneedling and diffuses transdermally via microchannels.

20. The kit of claim 16, wherein the non-permanent pigment suspension comprises at least one of iron oxide, titanium dioxide, and carbon black.

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