ITMI20101403A1 - USE OF ANTHROPOSOPHICAL REMEDIES FOR THE TREATMENT OF ALOPECIA - Google Patents

Description

Description of the patent for industrial invention entitled:

"USE OF ANTHROPOSOPHIC REMEDIES FOR THE TREATMENT OF ALOPECIA"

Field of the invention

The present invention relates to the use of enhanced organ preparations including aponeurotic galea for the treatment of alopecia, in particular of androgenetic alopecia.

State of the art

Anthroposophical medicine is a discipline based on the concepts of Rudolf Steiner, Austrian philosopher and scientist, founder of anthroposophy (from the Greek àntropos = man and sofia = science, knowledge).

The use of animal organs for therapeutic purposes has long been pursued, for example in homeopathy, xenotransplantation, etc.

In the case of xenotransplants, these are raw organs used in the substitute sense.

In homeopathy, the use of enhanced lower animals and their poisons (for example Apis, Lachesis, Bufo, etc.) is of great significance.

The use of enhanced healthy organs of higher animals developed on the recommendation of Rudolf Steiner.

In anthroposophic medicine, so-called enhanced organ preparations are used.

These preparations undergo a pharmaceutical transformation process before use in therapy, in order to get closer to the human organism.

These drugs induce a stimulation and modification of the processes intrinsic to the human body, providing the prerequisite for an active reaction.

There is no direct relationship between organ and organ preparation capable of "extinguishing" the underlying disease and its symptoms.

It is therefore necessary to develop an ever broader and more integrated understanding of the organs and their mutual relationships, for example rickets is treated with a pituitary preparation.

In anthroposophical medicine we speak of the therapeutic principle of "binaries". The properties of an organ or a system of organs are exploited, as if they were "binaries", to address other remedies or to directly concentrate their action.

Today, the Wala anthroposophic organ preparations available are mostly derived from cattle raised in biodynamic pastures.

Alopecia refers to the absence or lack of hair or hair in the areas of skin where they are normally present.

Alopecias are generally classified into:

- temporary-dysfunctional (non-cicatricial) characterized by a transient functional inhibition of the hair papilla,

- definitive (cicatricial) characterized by the disappearance of the follicle and the germinative papilla.

Among the non-cicatricial alopecia, the most frequent is the so-called androgenetic alopecia, also called common baldness.

Androgenetic alopecia, as the name implies, has two concomitant causes: androgens and hereditary predisposition.

Common baldness does not affect all hair, but only the androgen-dependent ones in the forehead-temporal region and the vertex.

The most relevant hormone for the development of baldness is dihydrotestosterone (DHT), which is the most important androgen hormone.

DHT is produced locally in the hair follicle by type II 5-alpha-reductase, which converts testosterone, which reaches the follicle through the blood vessels, into dihydrotestosterone.

Follicles predisposed to androgenetic alopecia produce greater amounts of DHT than follicles that are not affected by the disease.

The thinning of the hair is the consequence of a process of shrinking of the follicle (miniaturization).

The terminal follicles of the scalp progressively transform into follicles similar to those of the fleece, the duration of their growth phase becomes shorter and shorter and the hair produced shorter and thinner.

In this area, the hair therefore undergoes a progressive thinning caused by androgens.

Currently baldness can be treated both by pharmacological and by surgical means.

The most used drug is finasteride, an inhibitor of type IL 5-alpha-reductase.Therapy with finasteride must be carried out for life, since not only after a few months from the suspension the hair returns to fall but a possible resumption of the therapy does not lead to the same beneficial effects.

The side effects associated with the use of finasteride can be resolved with the suspension of the drug.

Another widely used drug is minoxidil. The use of the latter must be prolonged over time because its suspension brings the hair back to a pre-therapy stage.

Alternatively or in addition to drug therapy, there is surgical therapy, which consists, for example, of autotransplantation.

Androgenetic alopecia is the most common hair disease, it is estimated that about 1 80% of males and 50% of females show some signs of baldness over their lifetime.

Given the spread of this disease and considering the problems associated with known therapies, there is still a need to use alternative preparations in the prevention and / or treatment of alopecia, in particular of androgenetic alopecia (common baldness).

Summary of the invention

The present invention refers to an enhanced organ preparation comprising aponeurotic galea for use in the treatment of alopecia.

List of figures

Figure 1 shows the results obtained following the measurements made by pull-test.

Figure 2 shows the percentage of "satisfied" volunteers based on the judgments expressed by the volunteers after 120 days from the start of treatment relating to the efficacy of the product.

Figure 3 shows the percentage of "satisfactory" cases based on the judgments expressed by the investigating doctor after 120 days from the start of treatment relating to the efficacy of the product.

Description of the invention

It has surprisingly been found that an enhanced organ preparation comprising aponeurotic galea is useful in the prevention and / or treatment of alopecia, in particular of androgenetic alopecia, both male and female.

In humans, the aponeurotic galea (aponeurosis) is a thin band of connective tissue, which covers the upper part of the skull, covering the muscles and continuing in the tendon to ensure bone insertion to the muscle.

The aponeurotic galea in humans runs between the occipital area and the frontal area, laterally connects to the ear muscles and is anchored to both the integument and the skull with different tissue structures.

In cattle, only the frontal muscle is present. Epicranial aponeurosis (galea aponeurotica) connects this muscle to the bone of the same name, originating anteriorly at the base of the horns. The aponeurotic galea is thin and continues rostrally between the two orbits to give rise, on the back of the nose, to the levator nasolabial muscle of each side.

WALA Italia S.r.l. produces and markets under the name of Galea Aponeurotica Gl, an enhanced organ preparation containing bovine aponeurotic galea. This product is available on the Italian market in the form of a solution for injection subcutaneously, in packs of 10 ampoules of 1 ml, with dilution D5.

The Galea Aponeurotica Gl product has been notified to the competent Ministry of the matter in Italy for use in anthroposophic medicine.

The present invention relates to the use of an anthroposophical remedy (enhanced organ preparation) including aponeurotic galea for the prevention and / or treatment of alopecia.

In particular, the enhanced organ preparation including aponeurotic galea is useful in the prevention and / or treatment of androgenetic alopecia, both male and female.

For the creation of the enhanced organ preparation including aponeurotic galea, the anatomical parts can be taken and processed immediately after the slaughter of a healthy bovine and bred preferably on a biodynamic farm (DEMETER certification) or in controlled closed farms.

According to a preferred embodiment, the bovine aponeurotic galea is taken from a calf under the age of 6 months.

Two areas of aponeurotic galea tissue can be taken, each can be approximately equal to 1 cm, preferably from the frontal area and the dorsum of the calf's nose.

According to a preferred aspect, the aponeurotic galea tissue used belongs to Category 4 of tissues according to the EMEA guidelines on the risk of transmissibility of TSE. (CPMP CATEGORY 4: No detectable infectivity. "No infectivity was transmitted in bioassays involving inoculation of up to 5 mg of tissue into rodent brains." Taken from: Committee for Proprietary Medicinal Products; Note for guidance on minimizing the risk of transmitting animai spongiform encephalopathy agents via medicinal products: revision Sept. 2000).

The tissues are removed and weighed, deprived of blood residues and very finely chopped, preferably in a porcelain mortar with the addition of a quantity of sea sand if necessary.

Then 1 part of this preparation can be mixed with 5 parts of a hypertonic saline solution (40 g / kg).

It is possible to proceed to a new phase of comminution of the mixture until the total absence of visible particles.

After this the preparation obtained can be added with 95 parts of glycerol (for example according to the European Pharmacopoeia glycerol monograph), under stirring.

The entire mixture is transferred to a sterile, closed container and placed at rest away from light at room temperature for no less than 7 days.

You can then proceed with the decantation and transfer of the dye into lined, sterile and closed containers. This phase can possibly be preceded by centrifugation and / or filtration if necessary.

It is therefore possible to obtain the first Gl mother tincture with dilution D2, or Galea Aponeurotica Gl D2.

The glycerol used is preferably of vegetable extraction.

The abbreviation "Gl" following the name of the preparation indicates that the mother tincture has a glycerine content.

You can then continue with the enhancement to obtain the subsequent dilutions, following the enhancement specifications set by method 41b reported in the German Homeopathic Larmacopoeia.

The vehicle used for enhancement can be a solution of 0.2 parts of sodium hydrogen carbonate (sodium bicarbonate) and 8.8 parts of sodium chloride in 991 parts of water for injections.

The mother tincture obtained corresponds to the 2nd (second) decimal dilution (0 = D2).

The 3rd (third) decimal dilution (D3) can be obtained from:

I part of mother tincture (D2) e

9 parts of the enhancement vehicle described above.

Subsequent dilutions can be obtained by following the same procedure described for obtaining the third decimal dilution.

Dilutions up to D30 are generally obtained, such as D5, D6, D8, D30.

According to a preferred aspect, the dilution is D5.

The concentration of tissue extract in the finished product for dilution D5 is preferably 0.01 mg / ml.

According to a preferred aspect of the invention, the enhanced organ preparation is Galea Aponeurotica Gl.

The preparation of Galea Aponeurotica Gl can be produced according to the homeopathic production method reported by the German Homeopathic Pharmacopoeia (HAB 41B).

The enhanced organ preparation comprising aponeurotic galea can be used topically, for example in the form of lotion, foam, spray, spray preparation without gas.

Preferably the enhanced organ preparation comprising aponeurotic alea is administered by subcutaneous injection.

According to a preferred aspect, 1 ml of an enhanced organ preparation comprising aponeurotic galea is administered by subcutaneous injection, on the area affected by the thinning, with a frequency from once a week to once a day.

The example below further illustrates the invention.

Example

An experimental study was conducted to test the effectiveness of injected enhanced organ preparations intended for the treatment of male and female androgenetic alopecia.

The study was conducted using Galea Aponeurotica bovis Gl D5 solution for subcutaneous injection.

20 volunteers participated in the study, including 11 men and 9 women, aged between 20 and 50 years.

The subjects presented androgenetic alopecia included in the I, II and III degree of the Hamilton-Norwood scale for men and in the I and II degree of the Ludwig scale for women, telogen effluvium.

Furthermore, the phototype was from I to IV according to the Fitzpatrick classification.

The experimental conditions of use were as follows:

Table 1

The experimental conditions adopted (sites and methods of inoculation, quantity of product applied, frequency and duration of treatment) reproduced the normal treatment conditions envisaged.

The effectiveness was tested both by instrumental measurements and by subjective evaluation by the volunteers and the investigating doctor.

1. Evaluation of efficacy (instrumental evaluations) The efficacy of the product was evaluated with the following instrumental evaluations:

<■> pull-test;

<■> videodermatoscopy performed with Dermascope digital videodermatoscope;

<■> photographic images.

At the time of inclusion (t = 0), after 90 days of treatment (t = 90) and after 30 days from the end of treatment (t = 120) the following instrumental measurements were carried out:

- cleaned -test: the resistance to traction of the hair was evaluated with the pull-test method. The principle of the pull-test consists in pulling lightly, on 3 areas of the scalp, about 10 hairs and noting the number of hairs extracted;

<■> videodermatoscopic images: images of the same area of the scalp were acquired at various experimental times using the Dermascope digital videodermatoscope (10x magnification) to evaluate any changes in the scalp, the number of bulbs / hairs and the diameter of the stem of the hair;

<■> photographic images: photographic images of each case were acquired at subsequent experimental times to highlight any clinically appreciable changes in the areas under examination, using a digital camera. The results were then processed as follows:

<■> pull-test: the means and the relative percentage variations of the individual values found at the different observation times were calculated;

<■> videodermatoscopic images: the images obtained at the different experimental times were compared to each other to highlight any changes in the areas under examination before and after treatment;

<■> photographic images: the images obtained at the different experimental times were compared to each other to highlight any clinically appreciable changes in the areas under examination before and after treatment.

1.1. Results of instrumental evaluations

<■> Pull-test

The results obtained at the end of the treatment (t = 90) showed that the treatment in question induced an average decrease of 42.7% in the number of hairs extracted with this technique, indicating an increase in resistance to traction. of hair, observed in 80% of treated cases.

These results were maintained after 30 days from the end of treatment (t = 120) in 40% of cases, improving in 30% of cases.

The results obtained are reported in Table 2 and represented in Figure 1.

Table 2

<■> Videodermatoscopic images

The examination conducted in videodermatooscopy revealed an increase in the number of hairs present in the skin areas considered.

This increase is also attributable to the modification induced by the tested product which allowed the modification of the fleece hairs present and their transformation into terminal hairs.

The comparison between the diameters of the hair shafts before and after the treatment clearly shows these differences.

<■> Photographic images

From the comparison of the pre and post treatment clinical images, a significant improvement is evident, albeit with differences, in almost all the cases treated.

2. Evaluation of effectiveness (subjective evaluation)

After 120 days of starting treatment, the volunteers and investigators expressed their judgment regarding the following statements:

- the product reduces hair loss;

- the product promotes the regrowth of new hair;

- the product decreases the thinning;

- the product improves combability.

For each statement, the volunteers and experimenters expressed their judgment according to the following scale:

0 = disagree, l = fairly disagree, 2 = agree, 3 = completely agree.

For each statement, the results were expressed in number and percentage of satisfied volunteers.

2.1. Results of subjective evaluations

The judgments expressed by the volunteers after 120 days from the start of treatment relating to the efficacy of the product highlighted the following:

- Γ80% of the volunteers reported that the product reduces hair loss;

- 65% of the volunteers reported that the product promotes the regrowth of new hair;

- 75% of the volunteers reported that the product decreases the thinning;

- 60% of the volunteers reported that the product improves combability.

The number of responses assigned to each statement (0 = disagree, l = fairly disagree, 2 = agree, 3 = completely agree) and the percentage of "satisfied" volunteers are shown in Table 3.

Table 3

For each statement, the percentage of "satisfied" volunteers is represented in Figure 2.

In Figure 2 the percentages refer to the answers given in relation to the following statements:

1: the product reduces hair loss

2: the product promotes the regrowth of new hair

3: the product decreases the thinning

4: the product improves combability.

The judgments expressed by the investigating physician after 120 days from the start of treatment regarding the efficacy of the product highlighted the following:

- the product reduces hair loss in 65% of cases:

- the product promotes the regrowth of new hair in 45% of cases: - the product decreases thinning in 65% of cases:

- the product improves combability in 50% of cases.

The number of responses assigned to each statement (0 = disagree, l = fairly disagree, 2 = agree, 3 = completely agree) and the percentage of "satisfied" volunteers are shown in Table 4.

Table 4

For each statement, the percentage of "satisfactory" cases is shown in Figure 3.

In Figure 2 the percentages refer to the answers given in relation to the following statements:

1: the product reduces hair loss

2: the product promotes the regrowth of new hair

3: the product decreases the thinning

4: the product improves combability.

3. Conclusions

The product under investigation was shown to be effective in the treatment of male and female androgenetic alopecia and in situations of telogen effluvium.

In particular, in androgenetic alopecia there has been a greater expression of terminal hair, while in situations characterized by telogen / defluvium an increase in the number of hairs has been achieved.

The results obtained in the instrumental evaluations highlighted an increase in resistance to traction withdrawal, a decrease in hair loss and the regrowth of new hair.

These results were confirmed by the opinions of volunteers and experimenters, who found the effectiveness (reduction of hair loss and reduction of thinning) of the product.

Claims (7)

CLAIMS 1. Enhanced organ preparation including aponeurotic galea for use in the treatment of alopecia. 2. Enhanced organ preparation according to claim 1, in which alopecia is androgenetic alopecia. 3. Enhanced organ preparation according to claim 1 or 2, in which the preparation is Galea Aponeurotica Gl. 4. Enhanced organ preparation according to claims 1-3, in which the preparation has a degree of dilution equal to D5. 5. Enhanced organ preparation according to claims 1-4, in which the aponeurotic galea is of bovine origin. 6. Enhanced organ preparation according to claims 1-5, for topical administration. 7. Enhanced organ preparation according to claims 1-5, for administration by subcutaneous injection. Milan, 28 July 2010