Clinical Trials Regarding The Use Of Melanotan For Therapeutic Use

Melanotan or afamelanotide is a chemical compound synthesized in the eighties to stimulate the production of melanin in the human body. By stimulating the release of melanin, the skin darkens and becomes resistant to sun injury. Though no pharmaceutical company has the right to sell legally melanotan, trials are been conducted to prove its therapeutic purpose.

Introducing Clinuvel

Clinuvel Pharmaceuticals Ltd is an international pharmaceutical company that focuses on developing treatments for severe skin disorders. The company has set out to study the interaction of light and human skin. While doing so, two types of patients were identified: those that need to be protected from the light and those in need of skin pigmentation. Between 5000 and 45 million people have trouble with sun exposure and are in need of a cure.

Looking into EPP and vitiligo

Therapeutic Use1Clinuvel Pharmaceuticals Ltd aims to find cures for skin disorders resulted from exposure to light. One of such disorders is vitiligo. Patients with vitiligo suffer from depigmentation in certain areas of the body. This is caused by the absence or lack of activity of melanocytes (the cell specialized in skin pigmentation). No one really knows what causes this disorder. But researchers believe this is an autoimmune disorder. Regardless the cause, one thing is for sure: vitiligo causes serious psychological and emotional distress.

Another disease Clinuvel Pharmaceuticals Ltd has been striving to cure is erythropoietic protoporphyria. This is a rare genetic metabolic disorder that makes patients over-sensitive to sunlight and some types of artificial light such as fluorescent light. After being exposed to light, patients suffering from this condition accuse skin itchiness and burning hands, face or legs. Severe cases are related to liver or gallbladder failure.

Research results regarding erythropoietic protoporphyria

So far, erythropoietic protoporphyria or EPP was cureless. But after the third trial phase, afamelanotide or melanotan has been proved to be effective when used as a preventive treatment for EPP. Patients receiving the treatment claimed they experienced less pain when exposed to light. Also, the number of toxic reactions to light has dropped by 50%. Melanotan has helped patients to be exposed to sunlight for longer periods of time without feeling pain. Source: Melanotan Forum

Also the quality of life has been improved for patients sensitive to light. Also, no safety concerns were reported during the trial. As of May 2016, European Commission has granted marketing authorization to Clinuvel Pharmaceuticals Ltd to sell afamelanotide (or melanotan) to adults with EPP. Further discussions will take place between the European Medicine Agency and Clinuvel Pharmaceuticals Ltd before the company can begin distributing the drug to the public.

It seems research has reached some conclusion, after all. It is worth mentioning that Clinuvel has insisted on declaring that melanotan has nothing to do with their trials regarding afamelanotide. However, studies indicated that both products contain the same active compound. So we can expect to see melanotan in pharmacies soon, but not sooner than 18 months. In this period of time, SCENESSE – the stage name of afamelanotide must go through a strict risk management plan until can be marketed safely.

But until then, all the drugs that promise a tan that will last the entire year are still illegal and potentially dangerous. The wait is almost over.

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