It was recently learned that a study is underway to demonstrate the efficacy and safety of Melagenina Plus in patients with vitiligo.
The drug is not unknown to Cubans; its first versions began to be used in the 1980s. In the 1990s, various formulations of the product were tested until the current version, known as Melagenina Plus, was obtained. It was widely studied through clinical trials in 2008.
An article published on the website of the National Medical Library of the United States refers to Melagenina, among other “unconventional” products for the treatment of vitiligo. The authors regret that there is no updated data about the drug.
In order to compete in the demanding international market, it is necessary for medicines to meet certain standards. Hence the need and importance of new clinical trials being carried out in Cuba now to demonstrate the safety and efficacy of Melagenina Plus.
Today we will talk about the origin of the medicine and the advantages of its Plus version, as well as some general characteristics of the disease it combats.
What does skin color depend on?
Melanin is the substance produced by our body responsible for skin color. And not only this, but also the hair and the iris of the eye. Its production depends on a set of highly specialized cells, called melanocytes. These are found in the outermost layer of the skin, known as epidermis, more specifically in the basal membrane, which supports and nourishes it.
Once produced, melanin is distributed to the rest of the cells of the epidermis and determines the tone of the skin. Therefore, people with lighter skin have, consequently, a lower concentration of melanin, while those with darker skin have a higher concentration.
It is not a whim of nature
An article published in National Geographic explains the importance of melanin from an evolutionary perspective. This pigment has the function of protecting the human body from solar radiation. As is known, the first antecedents of homo sapiens arose in Africa, where exposure to this type of radiation is very high, hence the predominant skin tone on the African continent is dark.
When some communities migrated to regions further away from the equatorial belt, dark skin pigmentation became an adaptive disadvantage and new shades emerged.
A study published in 2014 in The Royal Society suggests that, contrary to what had been suspected for centuries, the higher concentration of melanin in the skin of the inhabitants of the African continent is an adaptive advantage to prevent cancer in this organ.
In any case, melanin is an indispensable element in the constitution of the skin of human beings. Deficiencies in its concentration determine different disorders or diseases.
According to the MNS Manual, skin pigmentation disorders are divided into three large groups. Hypopigmentation, which is nothing more than an abnormally low concentration of melanin in the skin. When it is generalized, we are in the presence of albinism. The most serious form of this pathology is oculocutaneous. Those who suffer from it have a white or pink coloration of the skin, the iris of the eyes and the hair, and it is accompanied by visual disorders.
Other factors that can generate hypopigmented areas are blisters, burns, infections, exposure to chemical agents and skin diseases whose lesions have healed, such as psoriasis or atopic dermatitis, among others.
Hyperpigmentation, on the other hand, will not depend solely on an increase in the concentration of melanin. Other factors can determine it, such as inflammatory processes, some diseases, use of certain medications and exposure to sunlight.
Skin depigmentation is a consequence of the disappearance of melanin. It can be generalized or localized. When depigmentation occurs, we are in the presence of vitiligo.
What is vitiligo?
The causes of the disease are not entirely known. It is known that the determining factor is the death of melanocytes, the cells specialized in the production of melanin.
Among the hypotheses that attempt to explain this phenomenon are hereditary factors, since vitiligo can appear in families. Another cause invoked is the presence of autoimmune factors.
The latter refers to the erroneous action of the immune system, that is, defense, attacking the body’s cells, in this case the melanocytes. Finally, a relationship has been observed that is not fully explained between vitiligo and certain particularly hormonal diseases. Among them we have some pathologies that affect the thyroid, others such as diabetes mellitus, etc.
The diagnosis of this disease is quite evident. A specialized doctor is able to distinguish areas of depigmentation, although sometimes he uses specialized instruments for this purpose. Blood tests are usually carried out to rule out the relationship with other diseases such as those mentioned above.
Vitiligo affects with predilection certain areas of the human body, especially around natural orifices such as the mouth, nose and eyes. The nipples, elbows, fingertips, wrists, knees, and genital and perianal areas are also often depigmented.
The disease is usually symmetrical, that is, it appears on both sides of the body and is rarely generalized, which means that it does not usually affect the entire body.
The different treatments for this disease have not yet managed to cure vitiligo, especially in those patients who have large areas of affected skin.
The topical use, that is, on the skin, of powerful corticosteroids such as clobetazole, has been the most commonly used treatment over the years, although without much success.
Calcineurin inhibitors have also been used. This is an enzyme that participates in the inflammatory process of the skin and is related to the death of melanocytes.
Another therapeutic option is treatments based on ultraviolet light, which require up to more than 100 sessions and increase the risk of skin cancer.
In some cases, surgery is used, that is, the grafting of segments of the individual’s own skin in some areas. When the lesions are small, some people may choose to get a tattoo to restore coloration.
Finally, in some cases of generalized vitiligo, patients choose to depigment the rest of their body. This considerably increases the risk of skin cancer and involves serious discomfort due to the adverse effects of the medications used for this purpose.
What is Melagenina Plus?
Melagenina is a product that we owe to the ingenuity and talent of the Cuban gynecologist and pharmacologist Dr. Carlos Manuel Millares Cao (1939-2015). This Cuban scientist demonstrated, in the mid-1970s, that an extract of human placenta in an alcoholic solution was capable of causing the production of melanin by melanocytes, which is technically known as melanogenesis.
Additionally, this product is responsible for the multiplication of this group of highly specialized cells, whose number and function is affected in cases of vitiligo.
According to a publication on the website of the Cuban health and tourism agency Health in Cuba, due to the success of this product in the mid-1980s, plants were created for the production of Melagenina.
However, the treatment in those early years was cumbersome, because the drug had to be applied to the depigmented skin every 8 hours. Then, the patient was exposed to sunlight for at least 15 minutes. These peculiarities resulted in the incorrect adherence of the treatment by the patients, and in some cases its abandonment.
For this reason, at the end of the 1990s a new formulation was conceived that sought to guarantee a simpler way of applying the product, as well as greater effectiveness and adherence to the treatment.
This was achieved with the inclusion of calcium in the original formulation. This allowed the product’s activity to be extended from 8 to 24 hours and avoided the need for patients to be exposed to sunlight, which also reduced the risk of developing some form of skin cancer. This is how Melagenina Plus came about.
According to a specialized medical publication, Melagenina Plus is effective in 86% of cases, in which it has been able to achieve re-pigmentation of up to all of the affected skin in some patients.
Among the factors that determine the effectiveness of the product are the age at which it is applied. It has proven to be much more beneficial in patients under 15 years of age, although it is successfully applied at any age.
The extension of the skin area affected by vitiligo is also an important factor. In those patients who have less than 40% of their body surface affected, the results are significantly better.
According to the study cited, there are no significant differences in terms of the sex of the patients or the duration of treatment with the product.
To learn more about vitiligo and Melagenina Plus, OnCuba had the opportunity to speak with Dr. Zobeira Aguirre Ulloa, a specialist in Dermatology with extensive experience in the management of these patients.
Is vitiligo common?
Dr. Aguirre Ulloa: Yes, it is a very common disease, which is the subject of study by our specialty. Theses have been carried out and it has been possible to determine an important genetic component in the appearance and development of this condition.
What is the natural history of this disease?
Dr. Aguirre Ulloa: Vitiligo generally begins periorificially, around the mouth, eyes.… There is a diagram that helps to determine the extent of the affectation. A patient may have 25%, 50%, even up to 75% of the body surface affected.
In my experience, the extent of the depigmented area is related to the etiology.1 It is important to remember that vitiligo often does not appear alone, but is related to other diseases, including genodermatoses.2
One element that I have frequently observed is its relationship with stress, which is a significant factor. Unexpected situations, such as the death of a family member, a divorce, or cases of people with difficulty in handling stressful or unexpected situations, usually have a more unfavorable evolution and an increase in depigmented areas is observed.
Could it be said that it is a psychosomatic disease?
Dr. Aguirre Ulloa: Undoubtedly the psychological factor is very important. There are people who, when we inform them of the diagnosis of vitiligo, accept it very naturally. In these people, the progression of the disease is usually less. In others, the psychological impact is very significant, especially when the depigmented areas are on the face; this becomes a real problem for them.
What are the treatment options for this disease?
Dr. Aguirre Ulloa: Although multiple treatment options have been tested, in reality none have been shown to be capable of curing vitiligo.
In our country, thanks to the work of Dr. Millares with the human placenta, Melagenina was patented, which has been used very successfully for decades and was even marketed abroad.3
What has been your experience with this medicine?
Dr. Aguirre Ulloa: It is a medicine that is effective, but it does not work miracles. In my experience, it takes time for a plaque to “close” with Melagenina. Sometimes the skin recovers its pigmentation after six months of treatment. In addition, the closure of a plaque does not mean that another depigmented area cannot appear in another region of the body.
Are there other therapeutic methods for managing the disease?
Dr. Aguirre Ulloa: We have had good results with the use of autologous plasma, that is, with the patient’s own plasma, in the management of facial vitiligo. There have been patients with a significant level of re-pigmentation with this method.
Have you observed adverse effects in patients who have used Melagenina?
Dr. Aguirre Ulloa: No, it is a drug with a very favorable safety profile and in my medical experience it has not presented adverse effects. But it must be handled with precaution.
Children should not handle it. In addition, contact of the drug with the mucous membranes must be avoided because the drug cannot be applied to them, even if they are depigmented; I am referring to areas such as the mouth, nose, genitals, etc.
To reach the international market
For more than 40 years, Melagenina has proven to be an effective and safe treatment option for vitiligo patients. The fact that it is produced from the human placenta, subject, of course, to strict safety measures, guarantees the raw material for the production of this medicine.
At this moment, a phase 3 clinical trial is being carried out in our country. This is surely due to the need for the medicine to comply with international standards for its certification and marketing in the international market.
Hopefully all this will help to increase access to this medicine in the network of pharmacies and hospitals in Cuba.
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Notes:
1 Etiology describes the cause or causes of a disease.
2 Genodermatoses are genetic diseases that manifest through different skin lesions; an example is Cowden Syndrome (Multiple Hamartomas Syndrome).
3 In the research we conducted for this article, we found that the product is available in virtual stores such as Amazon and Mercado Libre.
Author
OnCuba Staff
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