WO2019135199A1 - Compositions and methods for exogenous pigment removal - Google Patents

Abstract

A method of removing exogenous ink from skin is provided. The method includes preparing the skin with an antibacterial solution; exfoliating an epidermal layer of the skin to expose a dermal layer of the skin, wherein the dermal layer contains the exogenous ink, and administering a formulation that includes an amount of lactic acid having a concentration of about.01 percent to about 10 percent to the dermal layer to remove a portion of the exogneous ink from the dermal layer of the skin.

Description

COMPOSITIONS AND METHODS FOR EXOGENOUS PIGMENT REMOVAU

CROSS-REFERENCE TO REUATED APPUICATION

This application claims priority to: U.S. Provisional Patent Application No. 62/613,705, filed on January 4, 2018, and entitled“COMPOSITIONS AND METHODS FOR EXOGENOUS PIGMENT REMOVAL”, which is incorporated herein by reference.

FIELD

The present disclosure relates generally to compositions and methods for removing exogenous pigment from skin, and particularly to methods that employ the use of compositions that include lactic acid.

BACKGROUND

Over two (2) billion people worldwide have at least one tattoo. Tattooing involves the placement of pigment into the skin's dermis, the layer of dermal tissue underlying the epidennis. This is typically done by making thousands of tiny pricks in the skin using a handheld machine with a needle affixed to it. The person applying the tattoo may dip the needle in the ink, turn on the motor that moves the needle, and apply the moving needle to the skin. The sharp needle pricks the skin quickly and repeatedly, dragging the ink and clinging to it down into the dermis. Modem tattoo machines can pierce the skin at a frequency of about 70 to about 120 cycles per second.

Tattoos can take any number of forms and can be applied on nearly any part of a human body, and, as such, many tattoos are visible in everyday life. The demand for tattoos continues to increase primarily for body art adornment and self-expression. Tattoos are also used for religious, cultural, and medical reasons. Roughly a third of tattooed adults say that having a tattoo makes them feel attractive (32%), and this percentage has grown considerably from 21% in 2012. Just over a quarter (27%) say that having a tattoo makes them feel more rebellious and two in ten (20%) feel more spiritual as a result of their tattoos. Tattooed adults also say that that having a tattoo makes them feel more intelligent (13%), respected (13%), employable (10%) and healthy (9%). See:“Tattoo Takeover: Three in Ten Americans Have Tattoos, and Most Don’t Stop at Just One,” The Harris Poll® #12, February 10, 2016 (the “Harris Poll”).

About 29% of Americans have at least one tattoo, and 69% of tattooed Americans have two or more tattoos. Tattoos are especially prevalent among younger Americans, with 47% of people ages 18-35 having at least one tatoo. About 36% of people ages 35-50 have at least one tattoo, and 13% of people ages 51-69 have at least one tattoo. See: The Harris Poll, ibid.

Nearly 23% of tattooed Americans, or approximately seventeen million people, express regret about getting a tattoo. Individuals may regret getting a tattoo because they were too young when they got the tattoo, their personality or lifestyle has changed, the tattoo incorporated someone’s name they no longer are with, or the tattoo was poorly done, unprofessional, or otherwise no longer meaningful. The number of tatoo removal procedures in the U.8. reached 45,224 in 2013 compared to 40,801 procedures in 201 1. Women seem to be having the hardest time with their ink, seeing as they accounted for 32,888 (72.7 percent) of procedures. The amount of money paid for tattoo removal treatments also experienced a steep increase, doubling from 2011 to 2013. See: The Hams Poll, ibid.

SUMMARY

In an aspect, a formulation for removing exogneous ink from skin is provided. The formulation comprises an amount of lactic acid having a concentration of about .01 percent to about 10 percent of the formulation. In embodiments, the concentration of lactic acid is about .01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of arbutin having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of licorice root extract having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of retinol having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of at least one peptide, wherein the at least one peptide has a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of chamomile-flower extract having a concentration of about 0.01 percent to about 4 percent of the formulation. In embodiments, the formulation includes an amount of green tea extract having a concentration of about 0.01 percent to about 6 percent of the formulation.

In another aspect, a method of removing exogenous ink from skin is disclosed The method involves preparing the skin with an antibacterial solution, exfoliating an epidermal layer of the skin to expose a dermal layer of the skin, wherein the dermal layer contains the exogenous ink, and administering a formulation as detailed herein to the dermal layer to remove a portion of the exogneous ink from the dermal layer. In embodiments, the method further involves preparing the skin with a numbing cream. In embodiments, the method further involves applying a formulation as detailed herein to the exfoliated skin. In embodiments, the administering step is carried out using a tattoo application machine and needle. In embodiments, the exfoliating and administering steps occur at the same time. In embodiments, the method further involves irrigating the dermal layer following the administration step. In embodiments, the irrigating comprises irrigating with a solution that comprises water and salt.

In another aspect, a formulation for removing ink from skin is provided. In embodiments, the formulation includes an amount of lactic acid having a concentration of about 1 percent to about 75 percent of the formulation. In embodiments, the concentration of lactic acid is less than about 10 percent.

In embodiments, the formulation includes an amount of arbutin having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of licorice root extract having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of retinol having a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of at least one peptide, wherein the at least one peptide has a concentration of about 0.01 percent to about 5 percent of the formulation. In embodiments, the formulation includes an amount of chamomile- flower extract having a concentration of about 0.01 percent to about 4 percent of the formulation. In embodiments, the formulation includes an amount of green tea extract having a concentration of about 0.01 percent to about 6 percent of the formulation.

In embodiments, the formulation further comprises an amount of water and carya ovata bark extract having a concentration of about 4.5 percent to about 5.5 percent of the formulation. In embodiments, the water and carya ovata bark extract has a concentration of 5.0 percent of the formulation. In embodiments, the formulation further comprises an amount of glycerin and picea glauca bark extract having a concentration of about 0.5 percent to about 1.5 percent of the formulation. In embodiments, the glycerin and picea glauca bark extract has a concentration of 1.0 percent of the formulation. In embodiments, the formulation further comprises an amount of epilobium angustifolium flower/leaf/stem extract having a concentration of about 0.5 percent to about 1.5 percent of the formulation. In embodiments, the epilobium angustifolium flower/leaf/stem extract has a concentration of 1.0 percent of the formulation. In embodiments, the formulation further comprises an amount of glycerin and water and tasmannia lanceolate fruit/leaf extract having a concentration of about 1.5 percent to about 2.5 percent of the formulation. In embodiments, the glycerin and water and tasmannia lanceolate fruit/leaf extract has a concentration of 2.0 percent of the formulation. In embodiments, the formulation further comprises an amount of glycerin having a concentration of about 3.5 percent to about 4.5 percent of the formulation. In embodiments, the glycerin has a concentration of 4.0 percent of the formulation. In embodiments, the formulation further comprises an amount of xanthan gum having a concentration of about 0.1 percent to about 1.0 percent of the formulation. In embodiments, the xanthan gum has a concentration of 0.5 percent.

Other aspects and advantages of the inventions described herein will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate by way of example the aspects of the inventions.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 depicts a flow diagram for a process of removing a tattoo in accordance with various embodiments.

Figure 2A depicts a neck tattoo before and after a serum treatment, as described herein.

Figure 2B compares a finger tattoo: (i) after three saline treatments; and (ii) after one serum treatment, as described herein.

Figure 2C compares: (i) an untreated hand tattoo (left); (ii) a hand tattoo treated with one serum treatment (upper right); and (iii) a hand tattoo treated with two serum treatments (lower right), all as described herein.

Figure 2D compares: (i) an untreated tattoo (upper panel); to (ii) the same tattoo after three serum treatments (lower left panel), that can ultimately be covered by a cover-up tattoo (bottom right panel).

Figure 2E compares: (i) an untreated tattoo to (ii) the same tattoo after a first serum treatment, all as described herein.

Figure 2F compares: (i) an untreated tattoo to (ii) the same tattoo after four serum treatments, all as described herein.

DETAILED DESCRIPTION Definitions and Interpretation

Unless otherwise defined herein, scientific and technical terms used in connection with the present disclosure shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. The methods and techniques of the present disclosure are generally performed according to conventional methods well- known in the art and as described in various general and more specific references that are cited and discussed throughout the present specification unless otherwise indicated.

As used herein, the singular forms“a,”“an” and“the” are used interchangeably and intended to include the plural forms as well and fall within each meaning, unless the context clearly indicates otherwise. Also, as used herein,“and/or” refers to and encompasses any and all possible combinations of one or more of the listed items, as well as the lack of combinations when interpreted in the alternative (“or”).

All numerical designations, e.g., pH, temperature, time, and concentrations, including ranges, are approximations which are varied (+) or (-) by increments of about 0.1. It is to be understood, although not always explicitly stated that all numerical designations are preceded by the term“about.” The term“about” also includes the exact value“X” in addition to minor increments of“X” such as“X + 0.1” or“X - 0.1.” It also is to be understood, although not always explicitly stated, that the reagents described herein are merely exemplary and that equivalents of such are known in the art.

As used herein, the term“about” will be understood by a person of ordinary skill in the art and will vary to some extent depending upon the context in which it is used. If there are uses of the term which are not clear to a person of ordinary skill in the art given the context in which it is used,“about” will mean up to plus or minus 10% of the particular term.

The terms“administration of’ or“administering” an active agent, if used herein, should be understood to mean providing an active agent to the subject in need of treatment in a form that can be introduced into that individual's body in a useful form and effective amount to carry out the intended purpose of such administration.

As used herein, the term“comprising” is intended to mean that the compositions and methods include the recited elements, but not excluding others.“Consisting essentially of’ when used to define compositions and methods, shall mean excluding other elements of any essential significance to the composition or method.“Consisting of’ shall mean excluding more than trace elements of other components for claimed compositions and substantial method steps. Embodiments defined by each of these transition terms are within the scope of this disclosure. Accordingly, it is intended that the methods and compositions can include additional steps and components (comprising) or alternatively including steps and compositions of no significance (consisting essentially of) or alternatively, intending only the stated method steps or compositions (consisting of).

The terms“individual,”“subject,”“client,” and“patient,” if and as used herein, are used interchangeably herein, and refer to any individual mammal subject, including a human. If and as used herein, the terms“treatment” or“treating” generally refers to an intervention in an attempt to alter the natural course of the subject so afflicted with exogenous pigment.

Description of Aspects and Embodiments

There is a need to address the growing global demand for a safe, effective and cost- conscious way to remove exogenous pigment (e.g., tattoo ink) from the dermis of humans. It is not possible to completely destroy the pigment and since energy-based technologies (laser) and topical creams primarily trans-locate the pigment to the body’s lymphatic system where it resides for a long and indefinite period of time. Trans-epidermal elimination provides a safe and effective option to remove such pigments from the body.

In an aspect of the present disclosure, a process is provided to expose the pigment, to loosen the bond between the human cell and the pigment, to remove the pigment following irrigation with the serums detailed herein, and to promote healing with the serums detailed herein. In order to improve the body’s natural healing abilities and approach near complete pigment removal, specific serum formulations are developed and tested along with specific treatment protocols. As used herein, the term“serum” is used interchangeably with the terms “formulation” and“composition”.

The treatment may produce a wound in the top layers of the skin; various components listed herein provide dual purpose pigment loosening and wound repair. The body’s ability to heal this wound begins by hemostasis and the release of platelet derived factors. The proceeding wound repair stages include inflammation, granulation tissue formation, reepithelization and remodeling. In an aspect of the present disclosure, it is proposed that the serums and formulations detailed herein enhance the body’s natural ability to heal with combinations of these various components within its serums.

In an aspect, a formulation for removing ink from skin is provided. Serums are formulated to loosen the bond between the healthy skin cells and the encapsulated foreign pigment while promoting the production of collagen and dermal healing using a combination of components including natural and synthetic acids, soothing agents, delivery fluids, binders, irrigation fluids and healing agents.

In embodiments, the formulation includes an amount of lactic acid having a concentration of less than about 1 percent, about 1 percent, about 5 percent, less than about 10 percent, about 10 percent, about 15 percent, about 20 percent, about 25 percent, about 30 percent, about 35 percent, about 40 percent, about 45 percent, about 50 percent, about 55 percent, about 60 percent, about 65 percent, about 70 percent, or above about 70 percent of the formulation. In particular embodiments, the amount of lactic acid in the formulation is less than about 10 percent. As used herein, the term“lactic acid” refers to an alpha-hydroxy- acid used for exfoliation and when used topically can produce cosmetic results to the epidermis and dermis including skin smoothness and reduction in the depth and appearance of lines and wrinkles. It is water soluble and can be blended easily with other components used in serums. As used herein, the term“alpha-hydroxy-acids” refers to acids that are produced both naturally and synthetically. For cosmetic purposes it is easier to formulate and stabilize when produced synthetically. For the purposes of the serums and formulations detailed herein, alpha-hydroxy-acids are chosen to loosen the fluid binding skin cells and pigment in the dermis. Serum concentrations of alpha-hydroxy-acids required for older skin will be higher as the fluid binding dermal skin cells becomes denser with age or where hyperpigmentation (darkening of the skin caused by increased melanin) possibilities exist within a specific individual. Hyperpigmentation and hypopigmentation are associated with a number of diseases or conditions and are more common in darker skin types or individuals.

In embodiments, the formulation includes an amount of arbutin having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent to about 5 percent of the formulation. As used herein,“arbutin” refers to a water-soluble molecule extracted from the bearberry plant that prevents the formation of melanin in the skin and is therefore used as a lightening agent for the skin. Certain physiologies will benefit from arbutin specific inclusion in their serum formulations.

In embodiments, the formulation includes an amount of licorice root extract having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent to about 5 percent of the formulation. As used herein,“licorice root extract” refers to a water-soluble skin brightener used in cosmetics and is effective in treating inflammation induced skin hyperpigmentation. In addition to these aesthetic qualities, licorice root has been demonstrated to provide antiviral, antimicrobial and anti-inflammatory properties in the body when applied topically.

In embodiments, the formulations include an amount of retinol having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent to about 5 percent of the formulation. As used herein,“retinol” refers to a derivative of vitamin A used to stimulate the turnover of skin cells and increase collagen production. When used in very low doses, retinol can have dramatic results. Retinol when applied topically increases collagen production in fibroblasts. Fibroblasts are plentiful in the dermis and produce the collagen and elastin responsible for keeping skin healthy, pliant and springy.

In embodiments, the formulation includes an amount of at least one peptide, wherein the at least one peptide has a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent to about 5 percent of the formulation. In embodiments, peptides assist the healing process by stimulating collagen and elastin fibroblasts.

In embodiments, the formulation includes an amount of chamomile-flower extract having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent or about 3.5 percent to about 4 percent of the formulation. As used herein, “chamomile-flower extract” refers to a water-soluble moisturizing botanical for calming inflammation and is part of the administration and after-care portion of the serums and any of the formulations detailed herein.

In embodiments, the formulation includes an amount of green tea extract having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent, or about 5.5 percent to about 6 percent of the formulation. As used herein,“green tea extract” refers to a water soluble composition that reduces inflammation. The polyphenols in green tea provides antioxidant properties while epigallocatechin gallate assists with skin appearance.

In embodiments, the amounts of the components of the serum may depend on a number of components specific to each individual seeking tattoo removal. Factors may include age, health, skin color (pigmentation), previous chemotherapy/radiation, immunodeficiency, disease, smoker/non-smoker, and depth of ink. In embodiments, the serum formulation may include distilled water. In embodiments, the serum formulation may include thickening agents, stabilizers or preservatives. The serum may include hydroxyethylcellulose, a cellulose thickening agent, phenoxyethanol, a preservative and stabilizer, a mixture similar to optiphen, caprylyl glycol, which provides moisturizing and anti-microbial properties, chloroxylenol, a wound antiseptic agent, or sorbic acid, a preservative.

In embodiments, the formulation includes an amount of xanthan gum, a thickening agent, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent.

In embodiments, the formulation includes an amount of Euxyl K712, a preservative, which comprises aqua, sodium benzoate, and potassium sorbate, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent.

In embodiments, the formulation includes an amount of Euxyl PE9010, a preservative, which comprises phenoxyethanol and ethylhexylglycerin, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent.

In embodiments, the formulation includes an amount of blueberry extract in glycerin, an antioxidant, which comprises glycerin, aqua, viccinium, angustifolium (blueberry) fruit extract, which comprises phenoxyethanol and ethylhexylglycerin, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent.

In embodiments, the formulation includes an amount of Canadian willowherb, an antimicrobial, which comprises water, epilobium angustifolium flower/leaf/stem extract, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent. In embodiments, the formulation includes an amount of tasmanian pepperberry, a skin soothing agent, which comprises glycerin, water, tasmannia lanceolata fruit/leaf extract, having a concentration of about 0.01 percent, about 0.1 percent, about 0.25 percent, about 0.5 percent, about 1.0 percent, about 1.5 percent, about 2.0 percent, about 2.5 percent, about 3.0 percent, about 3.5 percent, about 4.0 percent, or about 4.5 percent, about 5.0 percent.

In further embodiments, the formulation includes lactic acid (30-50%), distilled water, an antioxidant agent (3-5%), a calming agent (0.1-2%), a thickening agent, a preservative agent, a preservative and antimicrobial agent, a stabilizing agent, a wound antiseptic agent, and a lightening agent. In embodiments, the antioxidant agent is a green tea extract. In embodiments, the calming agent is a chamomile extract. In embodiments, the thickening agent, is hydroxyethylcellulose. In embodiments, the preservative agent is phenoxy ethanol. In embodiments, the preservative agent is a mixture similar to optiphen. In embodiments, the preservative and antimicrobial agent is sorbic acid. In embodiments, the stabilizing agent is caprylyl glycol. In embodiments, the wound antiseptic agent is chloroxylenol. In embodiments, the lightening agent is licorice root extract. In embodiments, the lightening agent is arbutin from bearberry extract.

In embodiments, the formulation is any of the representative formulations detailed in Table 1.

Table 1: Representative formulations

In embodiments, and as shown in Table 1, the formulation is referred to as a 50 percent lactic acid formulation because the starting stock of lactic acid is 50 percent lactic acid. In additional embodiments, and as shown in Table 1, the formulation is referred to as a 70 percent lactic acid formulation because the starting stock of lactic acid is 70 percent lactic acid.

In further embodiments, the lactic acid formulation comprises water, a 90 percent lactic acid solution, water and carya ovata bark extract, glycerin and picea glauca bark extract, epilobium angustifolium, flower/leaf/stem extract, glycerin water tasmannia lanceolata fruit/leaf extract, glycerin, and xanthan gum. In embodiments, the percent water is between 75 percent and 82 percent of the formulation. In embodiments, the percent of 90 percent lactic acid is between 5 percent and 6 percent of the formulation. In embodiments, the percent water and carya ovata bark extract is between 4.5 percent and 5.5 percent of the formulation. In embodiments, the percent glycerin and picea glauca bark extract is between 0.5 percent and 1.5 percent of the formulation. In embodiments, the percent epilobium angustifolium flower/leaf/stem extract is between 0.5 percent and 1.5 percent of the formulation. In embodiments, the percent glycerin water tasmannia lanceolata fruit/leaf extract is between 1.5 percent and 2.5 percent of the formulation. In embodiments, the percent glycerin is between 3.5 percent and 4.5 percent of the formulation. In embodiments, the percent xanthan gum is between 0.1 percent and 1.0 percent of the formulation.

In embodiments, the formulation is between a 65 percent and 75 percent lactic acid formulation. In embodiments, the formulation is a 70 percent lactic acid formulation. In embodiments, the lactic acid formulation comprises water, a 90 percent lactic acid solution, water and carya ovata bark extract, glycerin and picea glauca bark extract, epilobium angustifolium flower/leaf/stem extract, glycerin and water and tasmannia lanceolata fruit/leaf extract, glycerin, and xanthan gum. In embodiments, the percent water is between 73 percent and 80 percent of the formulation. In embodiments, the percent water is 78.75 percent of the formulation. In embodiments, the percent of 90 percent lactic acid solution is between 7.25 percent and 8.25 percent of the formulation. In embodiments, the 90 percent lactic acid solution is 7.75 percent of the formulation. In embodiments, the percent water and carya ovata bark extract is between 4.5 percent and 5.5 percent of the formulation. In embodiments, the percent water and carya ovata bark extract is 5.0 percent of the formulation. In embodiments, the percent glycerin and picea glauca bark extract is between 0.5 percent and 1.5 percent of the formulation. In embodiments, the percent glycerin and picea glauca bark extract is 1.0 percent of the formulation. In embodiments, the percent epilobium angustifolium flower/leaf/stem extract is between 0.5 percent and 1.5 percent of the formulation. In embodiments, the percent epilobium angustifolium flower/leaf/stem extract is 1.0 percent of the formulation. In embodiments, the percent glycerin and water and tasmannia lanceolata fruit/leaf extract is between 1.5 percent and 2.5 percent of the formulation. In embodiments, the percent glycerin and water and tasmannia lanceolate fruit/leaf extract is 1.0 percent of the formulation. In embodiments, the percent glycerin is between 3.5 percent and 4.5 percent of the formulation. In embodiments, the percent glycerin is 4.0 percent of the formulation. In embodiments, the percent xanthan gum is between 0.1 percent and 1.0 percent of the formulation. In embodiments, the percent xanthan gum is 0.5 percent of the formulation.

In embodiments, saline solution or formulation may be used to irrigate the skin in order to wash away freed foreign pigment cells. For all serums specific pH balances are determined to ensure the potency of the free acids. Lower pH balances cause higher potent free acids which may be harmful and all formulations may be vetted by chemical and cosmetic compounders as well as practitioners familiar with their use in the dermal layers. Wound care specialists may confirm formulations and concentrations to promote wound repair assistance to the body’s natural ability to heal. Lastly, formulations may be amino acid free in order to ensure quick penetration to the dermis and pigments.

In another aspect, a method of removing ink from skin is provided. The method can be performed by technicians with experience as registered and licensed tattoo artists or permanent make-up aestheticians. The technicians should follow all regulatory rules, regulations and laws as it pertains to their license and jurisdiction for performing their work.

Initial selection for an individual seeking treatment as detailed herein involves healthy individuals to minimize the risk of secondary health complications and lifestyle issues and to be able to provide safe, effecting and cost-conscious solutions to pigment removal for all individuals desirous of removing their tattoo ink. The inclusion group can comprise the following criteria: Fitzpatrick scale (1-3), healthy and active, non-smoker, no known illness or disease, non-diabetic, and the tattoo location in high blood flow part of the body. The exclusion group can comprise the following criteria: Fitzpatrick scale (4-6), previous attempts at removal, keloid or pigmentation history, current or recent medication use, IV drug use, Hepatitis C, HIV/AIDS, or immune deficiency or history of wound healing complications.

Individuals may complete an intake form along with the informed consent form outlining the rights of the individuals and technicians. In addition, the technicians may complete the case report forms for each individual and associated treatment providing detailed information regarding the serum, procedure, process, aftercare and any other information required for the trials of such individuals.

Technicians should ensure the room is appropriately equipped with sterile equipment to remove ink from skin. A sterile garbage container should be located close to the working area as should a sink, the work tray and a sharps container. Technicians should wear protective gloves and place barrier film and cord bag on the tattoo application machine. Technicians should put in the individually packaged and lot numbered needle to the machine and place in front of the individual after setting up the tray.

To set up the tray, the technician should lay out a sterile tray liner (or dental bib) on a sterile tray. The technician may place a small plastic pigment cup on the tray for pigment bond loosening and removal serum. The technician may have additional serums available on the tray in case more is required. The technician may place additional cotton swabs and 4x4 cotton squares required during the procedure.

In an aspect, and referring specifically to Figure 1, the method 100 includes preparing the skin with an antibacterial solution (step 110), exfoliating an epidermal layer of the skin to expose a dermal layer of the skin, wherein the dermal layer contains ink (step 130), and administering the formulation to the dermal layer to remove ink from the dermal layer (step 140). In embodiments, the skin may be prepared by cleansing the area to be treated with Green Soap and 4x4 cotton square, rinsing with water and cotton square, patting dry with more cotton squares and disposing immediately. In-treatment numbing gel may consist of 5- 10% lidocaine and tetrocane without epinephrine, as epinephrine does not allow the bleed required for effective removal of irrigated and loosened pigment. In-treatment numbing may be channeled/needled into the treated area during the procedure.

In embodiments, the method includes preparing the skin with a numbing cream (step 120). In embodiments, the numbing cream is maintained on the skin for at least about 5 minutes, 10 minutes, or 15 minutes. In embodiments, the method includes pre-numbing, to which the pre-numbing cream, for example, Numb & Number, is applied to the area to be treated and allow it to work for 15 minutes prior to performing the procedure. During the pre numbing, the individual may complete any further intake questions required to better advise them on after-care specific to them and their unique lifestyle. Once complete, the technician may wipe off the pre-numbing cream, wash with anti-bacterial soap or solution, and pat dry with cotton squares, and dispose of used cotton squares.

In embodiments, administering the formulation to the dermal layer to remove ink from the dermal layer may be carried out using a tattoo application machine and needle. In embodiments, the exfoliating an epidermal layer of the skin to expose a dermal layer of the skin, wherein the dermal layer contains ink, and the administering the formulation used to remove ink from skin to the dermal layer to remove ink from the dermal layer may occur at the same time. In embodiments, the method includes irrigating the dermal layer following administering the formulation to the dermal layer to remove ink from the dermal layer (step 150). Once the treatment is completed, a cotton swab or a gloved finger can be used to apply irrigation and healing serum in a circular motion to clean any remaining loose pigments from the treated area. This will allow for maximum removal of loosened pigment and application of healing agents required to promote the most effective wound care possible at the earliest stage. The treated area now receives a final cleansing with antibacterial soap. Dispose of cotton swabs and any other cotton squares used in the irrigation and healing serum application stage.

Using additional cotton swabs or a gloved finger, the technician may apply the non petroleum anti-bacterial cream to the affected area and advise the individual to continue to apply the non-petroleum anti-bacterial cream to the area to protect the wound and keep it moist and bandaged during the post-treatment healing phase.

In embodiments, post-care precautions and procedures may depend on the lifestyle conditions of the individual and may include sealing the area with a breathable and waterproof, clear bandage sealed at its edges, for example SecuDerm. For optimal results, a water-proof and breathable foam bandage is used.

Thereafter, the technician may clean up by throwing out remaining disposables, and procedure gloves, reapplying gloves, and wiping down all surfaces with CaviWipes or CaviCide. The technicians may then discuss aftercare best practices with the individual, which are also specific to their physiology and lifestyle.

Efficacy In order to further demonstrate the efficacy of the serum, process and unique individual/serum match selection, a number of treatments on individuals with“before” and “after” photographic documentation were performed and individual and technician testimonials will be solicited.

Serum treatments using embodiments of the formulations described herein were performed on various tattoos. Figure 2A shows a neck tattoo before serum treatment (200) and the same tattoo after one serum treatment (210). Figure 2B shows a finger tattoo after three treatments with saline (220) and the same finger tattoo after one treatment with serum (230). Figure 2C shows an untreated hand tattoo (240); the same hand tattoo after one serum treatment (250); and the same hand tattoo after two serum treatments (260). Figure 2D compares an untreated tattoo (270) to the same tattoo after three serum treatments (280), which is also shown as a cover-up tattoo (290). Figure 2E shows a tattoo before serum treatment (300) and after serum treatment (310). Figure 2F shows a tattoo before serum treatment (320) and after four serum treatments (330). The serum treatments used in each of Figures 2A through 2F is the 70% LA formulation as defined in Table 2.

Phase 1 Efficacy Beta Tests involve selecting a defined number (e.g., ten) ideal candidate individuals to receive treatments on their tattoos with serums and the related processes. In Phase 2 Beta Tests,“before” and“after” photos are collected and technicians solicit individual feedback, suggestions and insights for improving each of the intake and information processes, serum compositions, treatment processes, aftercare products and protocols.

Of note, the disclosure of the described embodiments is intended to be illustrative, but not limiting, of the scope of the inventions, which are set forth in the following claims and their equivalents. Although example embodiments of the inventions have been described in some detail for purposes of clarity of understanding, it will be apparent that certain changes and modifications can be practiced within the scope of the following claims. In the following claims, elements and/or steps do not imply any particular order of operation, unless explicitly stated in the claims or implicitly required by the disclosure. Other aspects and advantages of the inventions described herein will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate by way of example the aspects of the inventions.

The following examples are given to illustrate aspects of the present invention. It should be understood, however, that the invention is not to be limited to the specific conditions or details described in these examples. All printed publications referenced herein are specifically incorporated by reference.

EXAMPLES

Example 1

An individual is initially selected for treatment using a variety of factors, including health and lifestyle issues to minimize the risk of secondary health complications and to be able to provide safe, effecting and cost-conscious solutions to pigment removal for all individuals desirous of removing their tattoo ink. Factors can include a score on the Fitzpatrick scale of 1-3, a healthy and active, being a non-smoker, having no known illness or disease, being non-diabetic, and having a tattoo location in high blood flow part of the body.

The technician completes the case report forms for each individual and associated treatment providing detailed information regarding the serum, procedure, process, aftercare and any other information required for the trials and individual. The technician ensures the room is appropriately equipped with sterile equipment to remove ink from skin. A sterile garbage container is located close to the working area as should a sink, the work tray and a sharps container. The technician wears protective gloves and place barrier film and cord bag on the tattoo application machine. The technician puts in the individually packaged and lot numbered needle to the machine and place in front of the individual after setting up the tray.

The technician sets up the tray by laying out a sterile tray liner (or dental bib) on a sterile tray and places a small plastic pigment cup on the tray for pigment bond loosening and removal serum. The technician has additional serums available on the tray in case more is required. The technician places additional cotton swabs and 4x4 cotton squares as required during the procedure.

The individual’s skin is first prepared by cleansing the area to be treated with Green Soap and 4x4 cotton square, rinsing with water and cotton square, patting dry with more cotton squares and disposing immediately. The technician applies a pre-numbing cream, for example, Numb & Number, to the area to be treated and allow it to work for 15 minutes prior to performing the procedure. During the pre-numbing, the individual completes any further intake questions required to better advise the individual on after-care specific to them and their unique lifestyle.

Once complete, the technician wipes the pre-numbing cream from the individual and rinse the area with water and pat dry the area with cotton squares. The technician disposes the used cotton squares. The formulation is administered to the dermal layer of the individual to remove ink from the dermal layer carried out using a tattoo application machine and needle. In-treatment numbing is channeled/needled into the treated area during the procedure with a pass after the first channeling/needling of the removal serum and after each additional pass but not after the final pass of the removal serum.

Once the treatment is completed, a cotton swab is used to apply irrigation and healing serum to clean any remaining loose pigments from the treated area. The technician may now clean the treated area with antibacterial soap such as Green Soap. Using additional cotton swabs, the technician applies the non-petroleum anti-bacterial cream to the affected area. The technician advises the individual to continue to apply the non-petroleum anti-bacterial cream to the area to protect the wound and keep it moist and bandaged during the post-treatment healing phase. The individual may also use other healing ointments that are non-petroleum based and anti-bacterial.

Post-care precautions and procedures depend on the lifestyle conditions of the individual and include sealing the area with a breathable and waterproof, clear bandage sealed at its edges, for example SecuDerm. For optimal results, a water-proof and breathable foam bandage is used. To further demonstrate the efficacy of the serum, process and unique individual/serum match selection, a number of “before” and “after” photographic documentations of the individual’s treated area of skin are performed.

Example 2

Serum formulations, as detailed in Table 2, were used to remove tattoos. The serum was applied exactly the same as the ink that was used to initially tattoo the skin. In this sense it was a reverse tattoo. The serum was tattooed into the dermis which caused loosening of the bond between the macrophage engulfed exogenous pigment cell and the surrounding dermis. A topical application was then applied by pouring the remaining serum from the ink cup onto the treated area and rubbing it around in light circles onto the surface of the treated area. This process ensured that the serum saturated the treatment area. This topical application was allowed to sit for 1-3 minutes before the skin was cleaned with antibacterial soap and covered with a bandage. In some instances, the serum treatment described above was repeated multiple times. Figures 2A-2F show results on various tattoos using the treatment scheme as described above.

Figure 2A shows reduced pigment in a neck tattoo (210) after one serum treatment using the 70% LA formulation as defined in Table 2. Figure 2B shows reduced pigment in a finger tatoo (230) after one serum treatment using the 70% LA formulation as defined in Table 2, relative to a finger tatoo (220) that received three saline treatments. Figure 2C shows reduced pigment in a hand tatoo (250) after one serum treatment using the 70% LA formulation as defined in Table 2, and a further reduction in pigment (260) after a second serum treatment using the 70% LA formulation as defined in Table 2. Figures 2D and 2E show a reduction in pigment of a tatoo (280 and 310) after one serum treatment using the 70% LA formulation as defined in Table 2. Figure 2F shows a reduction in pigment of a tatoo (330) after four serum treatments using the 70% LA formulation as defined in Table 2. Table 2: Formulations

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A formulation for removing exogneous ink from skin, the formulation comprising an amount of lactic acid having a concentration of about .01 percent to about 10 percent of the formulation.

2. The formulation of claim 1, wherein the concentration of lactic acid is about .01 percent to about 5 percent of the formulation.

3. The formulation of claim 1, further comprising an amount of arbutin having a concentration of about 0.01 percent to about 5 percent of the formulation.

4. The formulation of claim 1, further comprising an amount of licorice root extract having a concentration of about 0.01 percent to about 5 percent of the formulation.

5. The formulation of claim 1, further comprising an amount of retinol having a concentration of about 0.01 percent to about 5 percent of the formulation.

6. The formulation of claim 1, further comprising an amount of at least one peptide, wherein the at least one peptide has a concentration of about 0.01 percent to about 5 percent of the formulation.

7. The formulation of claim 1, further comprising an amount of chamomile-flower extract having a concentration of about 0.01 percent to about 4 percent of the formulation.

8. The formulation of claim 1, further comprising an amount of green tea extract having a concentration of about 0.01 percent to about 6 percent of the formulation.

9. A method of removing exogenous ink from skin, the method comprising:

(a) preparing the skin with an antibacterial solution;

(b) exfoliating an epidermal layer of the skin to expose a dermal layer of the skin, wherein the dermal layer contains the exogenous ink, and

(c) administering the formulation of claim 1 to the dermal layer to remove a portion of the exogneous ink from the dermal layer.

10 The method of claim 9, further comprising preparing the skin with a numbing cream.

11. The method of claim 9, further comprising applying the formulation of claim 1 on to the exfoliated skin.

12. The method of claim 9, wherein step (c) is carried out using a tattoo application machine and needle.

13. The method of claim 9, wherein steps (b) and (c) occur at the same time.

14. The method of claim 9, further comprising irrigating the dermal layer following step (c).

15 The method of claim 13, wherein the irrigating comprises irrigating with a solution that comprises water and salt.