APPARATUS AND METHODS FOR SKIN TREATMENT, DRUG

APPLICATION AND CREAM FORMULATION

FIELD OF THE INVENTION

The present invention relates to skin-treatment apparatus and methods, specifically devices and methods for the

treatment of skin wrinkles and methods for formulations of treatment creams. In particular, the invention relates to applying pressing forces on the apparatus in order to stretch the skin, and to applying treatment cream onto skin.

BACKGROUND

A significant feature of aging is the loss of skin elasticity and the formation of skin wrinkles.

Based on genetics, the environment and individuals' levels of skin care, almost all men and women get wrinkles at some point in their lives . Some people begin to observe wrinkles (called "crow's feet") in the corners of their eyes as early as 20.

The skin is composed of three layers: the outermost layer, called the epidermis, the dermis, and the subcutaneous or lowest layer of the skin. During youth, a person's

epidermis stretches and holds large amounts of moisture. High levels of elastin fibers and a protein, collagen, contained in the dermis, and fat in the subcutaneous layer, all contribute to this condition. Over time, the dermis loses collagen and elastin, and the skin becomes less elastic and less thick. As the epidermis receives less moisture, it starts to sag, and wrinkles form.

Each year, approximately 142 billion dollars are spent globally on treatments to eliminate, reduce or hide wrinkles. There are many options for treating wrinkles, ranging from low-level lasers, infrared light and intense pulsed light, to more invasive treatments include dermabrasion, laser

resurfacing and chemical peels.

SUMMARY OF THE INVENTION

The invention describes a method for treating the skin of a subject, the method including: reducing a wrinkle on the skin by deforming the skin for several minutes, with a mount configured for adhering to the skin of the subject; applying an amount of treatment cream to the skin; maintaining the reduction of the wrinkle after the mount is removed.

In some applications of the invention, a resilient structure is adhered to the skin of a subject around the area of a wrinkle, and deformed by a pressing force, in a manner such that the adhered areas are pulled further apart and the wrinkle is stretched and held for a period of hours .

Repetition of this procedure, typically on a daily basis, reduces the depth and, therefore, the appearance of the wrinkle .

In another application of the invention, a structure is adhered to the skin of a subject in a manner such that it facilitates drug administration.

In another application of the invention, a structure is adhered to the skin of a subject in a manner such that it increases the effectiveness of drug delivery.

In an application, reducing the wrinkle by deforming the skin includes flattening the wrinkle by stretching the wrinkle .

In an application, reducing the wrinkle by deforming the skin includes deforming the mount from one shape to another shape while the mount is adhered to the skin.

In an application the mount has an opening that enables application of a substance (e.g., skin-treatment cream or drugs) to the skin. In an application, deforming the mount from the one shape to the other shape includes deforming the opening from one profile to another profile.

There is therefore provided, in accordance with an application of the present invention, apparatus for use with skin of a subject, including:

A disposable Touch N' Lift mount, including a plurality of zones which are adhesively adherable to the skin and a zone which is not adhesively adherable to the skin. The mount is deformable from the one shape to the other shape, at least one of which is constrained, in response to application of a deforming force (e.g., a pressing or squeezing force) to the mount .

A treatment unit, positioned with respect to the mount such that by the mount moving from one shape to the other, one of which is constrained, the treatment unit is aligned vertically with the wrinkle and lies parallel to the plane of the skin.

Primer Touch N' Lift Treatment cream

In an application, the skin of the subject to which the zones of the mount are adhesively adherable has a plane, and the mount is configured such that when the mount is in the other unconstrained shape, the wrinkle on the skin is

stretched in the plane.

In an application, the mount is configured such that it remains in the other shape after removal of the deforming force .

There is further provided, in accordance with an

application of the present invention, a method for treating skin of a subject, the method including:

reducing a wrinkle on the skin by deforming the skin; maintaining the reduction of the wrinkle with a mount configured for adhering to the skin of the subject, the mount being shaped to provide an opening; and

reducing the flexibility of the skin by applying a glue to the skin via the opening provided by the mount.

In an application, the opening on the mount facilitates illumination of the skin of the subject.

In an application, the treatment unit allows for the use of any heat source, the heat source being configured to treat the skin of the subject.

In an application, the treatment unit allows for the use of ultrasound source or any light (e.g., blue light or red light), the light source being configured to illuminate and/or warm the skin of the subject.

In an application, the treatment unit includes any energy source, the energy source being configured to treat the skin of the subject.

In an application, the method further includes applying a substance (e.g., skin-treatment cream) to the skin of the subject while the mount is adhered to the skin.

In an application, biological glue is applied through the disposable mount which is adhesively adherable to the skin.

In an application, the method further includes removing the mount from the skin after the glue has become firm, such that the glue remains on the skin.

In an application, the method further includes applying a drug or dermal filler to the skin of the subject while the disposable mount is adhered to the skin and the skin is kept stretched by the mount.

In an application, the method further includes decoupling the apparatus from the site on the skin of the subject, and subsequently applying a drug to the site on skin of the subj ect .

There is further provided, in accordance with an

application of the present invention, a topical composition for the treatment of wrinkles in the form of base-cream comprising by weight based on the total weight of the composition :

(a) 0.117 to 0.129 percent [Disodium] EDTA (preferably 0.12 percent) , (b) 2.34 to 2.58 percent Lanoline (preferably 2.46 percent),

(c) 3.85 to 4.26 percent Cutina GMS V (preferably 4.06 percent) ,

(d) 3.85 to 4.26 percent Cetyl Alcohol (preferably 4.06 percent) , (e) 1.52 to 1.68 percent MYRJ 52 [Peg-40 Stearate]

(preferably 1.60 percent),

(f) 0.58 to 0.65 percent SPAN 65 [Sorbitan Tristeararte] (preferably 0.61 percent),

(g) 5.84 to 6.45 percent glycerin (preferably 6.15 percent), (h) 8.64 to 9.55 percent paraffin (preferably 9.10 percent),

(i) 17.40 to 19.23 percent isopropyllmiristate (IPM)

(preferably 18.31 percent),

( j ) 7.01 to 7.74 percent propylene glycol (preferably 7.37 percent) , (k) 0.07 to 0.08 percent Methylisothiazolinone (and)

Methylchloroisothiazolinone (Acnibio CT) (preferably 0.07 percent) ,

(1) 0.58 to 0.65 percent Cyclopentasiloxane and Dimethicone (Silicon 2355) (preferably 0.61 percent), (m) buffer to maintain the pH of the composition within the range of 6 to 7,

(n) water. There is further provided, in accordance with an

application of the present invention, a topical composition for the treatment of wrinkles in the form of water-in-oil emulsion comprising by weight based on the total weight of the composition : (a) 8.36 to 9.24 percent Propylen Glycol (preferably 8.80 percent) ,

(b) 0.57 to 0.63 percent Voluform (Palmitoyl isoleucine) (preferably 0.60 percent),

(c) 2.43 to 2.69 percent (preferably 2.56 percent) Base Cream,

(d) 1.54 to 1.70 percent Glycerin (preferably 1.62 percent),

(e) 9.74 to 10.76 percent Sesaflash (Glycerin & Acrylates copolymer & VP/polycarbamyl Polyglycol Ester & Hydrolyzed Sesam Protein PG-Propyl Methylsilanediol ) (preferably 10.25 percent) ,

(f) 4.06 to 4.49 percent Pentacare HP (Ceratonia Siliqua Gum, Hydrolyzed Casein) (preferably 4.27 percent),

(g) 4.06 to 4.49 percent Pentacare NA (Hydrolyzed Wheat Gluten, Ceratonia Siliqua Gum) (preferably 4.27 percent), (h) 33.28 to 36.78 percent Pepha Tight (Algae Extract,

Pullulan) (preferably 35.03 percent),

(i) 0.16 to 0.18 percent Pure Seduction Scent (preferably 0.17 percent ) ,

(j) 0.06 to 0.07 percent Acnibio CT (preferably 0.068 percent) ,

(k) 1.14 to 1.26 percent Sepigel 305 (preferably 1.20 percent) ,

(1) 2.92 to 3.23 percent Rona Flair LDP (preferably 3.08 percent) , (m) buffer to maintain the pH of the composition at exactly 7.0

(n) water.

In an application, the treatment cream is applied to a site on skin of the subject without use of the provided apparatus .

BEST MODE FOR CARRYING OUT THE INVENTION

To further illustrate the present invention in greater detail, the following Examples will be given.

EXAMPLE 1 (Base cream) - A topical composition for the treatment of wrinkles in the form of a water-in-oil emulsion comprising by weight based on the total weight of the composition:

9.07 percent Palmitoyl isoleucine (Voluform) ,

Glycerin & Acrylates copolymer & VP/polycarbamyl Polyglycol Ester & Hydrolyzed Sesam Protein PG-Propyl

Methylsilanediol (Sesaflash),

Ceratonia Siliqua Gum, Hydrolyzed Casein (Pentacare HP) ,

Hydrolyzed Wheat Gluten, Ceratonia Siliqua Gum (Pentacare NA) ,

Algae Extract, Pullulan (Pepha Tight) buffer to maintain the pH of the composition between 6.0 and 7.0. water. EXAMPLE 2 (Full cream)

A topical composition for the treatment of wrinkles in the form of a water-in-oil emulsion comprising by weight based on the total weight of the composition: - 8.80 percent Propylen Glycol,

0.60 percent Voluform (Palmitoyl isoleucine),

2.56 percent Base Cream (as described in Example 1),

1.62 percent Glycerin,

10.25 percent Sesaflash (Glycerin & Acrylates copolymer & VP/polycarbamyl Polyglycol Ester &

Hydrolyzed Sesam Protein PG-Propyl Methylsilanediol),

4.27 percent Pentacare HP (Ceratonia Siliqua Gum, Hydrolyzed Casein) ,

4.27 percent Pentacare NA (Hydrolyzed Wheat Gluten, Ceratonia Siliqua Gum) ,

35.03 percent Pepha Tight (Algae Extract, Pullulan) ,

0.17 percent Pure Seduction Scent,

0.07 percent Acnibio CT,

1.20 percent Sepigel 305, - 3.08 percent Rona Flair LDP (Silicon dioxide coated with: Titanium dioxide, Ferric oxide) , buffer to maintain the pH of the composition at exactly 7.0 water. The definitions of components whose chemical composition is not immediately clear from the name used may be found in the CTFA Cosmetic Ingredients Dictionary, 3rd Edition, published by the Cosmetic, Toiletry, and Fragrance Association, Inc., Washington, D.C. Evaluation Of Wrinkle-Reducing Device And Cream On Skin

Twelve adult female patients with facial wrinkles were treated with the Touch N' Lift device and Primer Touch N' Lift cream by Dr. Avner Shemer, Sp ialist in Skin and Venereal Diseases and Dermatologic urgeon, at Laniado Medical Center in Netanya, Israel, n December 2013.

The purpose of the study was to evaluate the efficacy of the treatment device and cream, and the tolerability of the products.

The cream obtained as described in Examples 1 and 2 above was applied to both right and left sides of the face. On the left side of the face, the cream was applied in conjunction with the Touch N' Lift device, and the device was removed 15 minutes after it was placed on the skin.

The treated areas were observed, photographed and evaluated before and after the treatment and after each of a series of two-hour intervals.

All patients tolerated the treatment with no adverse events or side effects.

The efficacy of the treatment during the 6 hours

following the treatment was also assessed by scoring the resulting changes to the skin. The following results were observed :

1. Most of the 12 patients exhibited improvement to complete cure .

2. A small number of patients showed mild improvement.

3. Better efficacy was marked in woman aged 35-55.

4. Three subjects had cream applied beneath the eyes in addition to the sides of the eyes, and marked improvement was shown beneath the eyes.

5. On the side of the face where the Touch N' Lift device was used (left side), the efficacy of the treatment was increased as compared with the side on which cream only was used (right side) .

In conclusion, this preliminary trial with a cream preparation according to the invention demonstrated good tolerability and an excellent temporary local effect in reducing, and in some cases eliminating, skin wrinkles.

These findings clearly indicate that the derivatives according to the invention can be advantageously used as active ingredients of topical compositions mixed with dermatologically acceptable inert carriers .

The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. 1A-B are schematic illustrations of a subject, of topical cream application, and of treatment apparatus, in accordance with respective applications of the invention;

Figs. 2A-D are schematic illustrations of various configurations of the treatment unit shown in Figs. 1A-B, in accordance with some applications of the invention;

Figs. 3-6 are schematic illustrations of a subject, of topical cream application, and of various configurations of the apparatus of Figs. 1A-B, in accordance with some

applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to Figs. 1A-B, which are schematic illustrations of apparatus 10, comprising apparatus 10a, being applied to skin 20 of subject 30, in accordance with some applications of the invention, and cream 50, being applied to skin 20 of subject 30, in accordance with some applications of the invention.

Reference is now made to Fig. 1A. Apparatus 10a is applied to a site on skin 20, typically such that adhesives 42 are positioned on two edges of wrinkle 24. Mount 40a is shown in an unconstrained shape, and adhesives 42a connect skin 20 to mount 40a. Adhesives 42a is typically found on two ends of mount 40a, on the skin-facing side, having properties that allow it to adhere to the skin strongly enough for effective use of this application of the invention, but not so strongly so as to make removal difficult or painful. Mount 40b

comprises a resilient material that typically allows the mount to be deformed between two shapes.

Typically, a user pushes down on mount 40a (i.e., applies a deforming force) as illustrated by arrow 44, deforming mount 40a and stretching skin 20 in the area of wrinkle 24, as illustrated by arrows 45. This behavior can be described as bistable, i.e., the apparatus is stable in two unconstrained shapes .

Reference is now made to Fig. IB. Due to the adhesion of adhesives 42 of apparatus 10a to the skin 20, the skin is automatically stretched, as shown by the increased distance between adhesives 42b. The treatment unit 35 including opening 36 is aligned vertically with the site of the wrinkle 24.

For some applications of the invention, cream 50 is applied to a wrinkled site on the skin via opening 36 of apparatus 10 (e.g., apparatus 10a) .

For some applications of the invention, apparatus 10 (e.g., apparatus 10a) is positioned and used to lift a non- wrinkled site on the skin. For example, the apparatus may be used to facilitate delivery of a drug via opening 36.

Reference is again made to Figs. 1A-B. Typically, apparatus 10 is left on the skin for a sustained period (e.g., at least three hours, and/or less than 18 hours, e.g., overnight) . During this period, the underlying skin is restructured by apparatus 10 in a manner that chronically treats the wrinkle. It is hypothesized that this sustained lifting of the skin has one or more of the following effects: induction of the influx of extracellular fluid and nutrients into the area of the lifted skin, improvement of skin

hydration, stimulation of skin cells, and modulation of collagen in the treated area. Typically, treatments using apparatus as described herein are applied repeatedly (e.g., every day, every second day, or once per week) and/or over an extended period (e.g., for at least a week, a month, or a year) . The applications of the invention illustrated in Figs . 1A-B may be combined with the application of drugs and/or energy to increase the rate of skin restructuring. Examples include the application of a topical drug, and the

administration of healing light, any energy source or

ultrasound to the skin before or while apparatus 10 is on the skin .

The combination of skin lifting with the application of a drug may be used on non-wrinkled sites on the skin. For example, the apparatus may be used to facilitate delivery of a drug (e.g., a drug not used for treating a wrinkle) .

The applications of the invention described with

reference to Figs . 1A-B may be used in combination with other applications of the invention described herein.

Reference is made to Figs. 2A-D, which are schematic illustrations of various configurations of the apparatus of Figs. 1A-B, in accordance with some applications of the invention. These figures show the skin-facing side of mount 40 and adhesives 42. These figures are not intended to limit the scope of the invention but, rather, to illustrate variations of shapes and configurations of mount 40, treatment unit 35, and adhesives 42 individually. For example: treatment unit 35b is generally rectangular in shape, and treatment unit 35c is generally elliptical in shape. Suitably-configured mounts may be selected, based on the skin area to be treated. The applications of the invention described with reference to Figs. 2A-D may be used in combination with other applications of the invention described herein.

Reference is made to Figs. 3-6, which are schematic illustrations of a subject, and of various configurations of the apparatus of Figs. 1A-B, in accordance with some

applications of the invention.

Each of Figures 3, 4, 5 and 6 shows an alternative configuration of the apparatus 10 (10a and 10b) in Fig. 1A and IB, respectively, and shows cream 50 being applied via opening 36, in accordance with some applications of the invention. Some of the mounts in these examples are monostable. The mount is first deformed by a force (e.g., a squeezing force) represented by arrows 103, 105, and 106 in Figs. 3A, 5A, and 6A, respectively, and then adhered to the skin in the area of the wrinkle. When the force is removed, the mount returns to its unconstrained first shape (represented by arrows 203, 205, and 206 in Figs. 3B, 5B and 6B, respectively) and the wrinkle is thus stretched.

The applications of the invention described with

reference to Figs. 3-6 may be used in combination with other applications of the invention described herein.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been

particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.