Clinical Trial Explores Methotrexate For Severe Alopecia Areata

Despite being an autoimmune condition, Alopecia Areata is the second most common cause of hair loss in the world.

There are a number of different forms that it can take, ranging from mild to severe, and, whilst there is no cure for any of them, topical applications of high strength minoxidil have been seen to be effective in treating moderate Alopecia Areata. With the more extreme variations, such as Alopecia Totalis and Alopecia Universalis, which cause baldness of the whole head and body respectively, however, there is still no truly reliable treatment which has proven to be both safe and efficient. Most have a success rate of 10 per cent or less.

Researchers are currently exploring a number of possibilities, with the latest being a clinical trial at the University Hospital Rouen in France, which is looking into methotrexate as a potential treatment.

What is methotrexate?

According to the NHS-recommended website medicines.org.uk, methotrexate is 'a folic acid antagonist and is classified as an antimetabolite cytotoxic agent'.

It further states that the medication is generally used to cause regression of a wide range of cancers including 'acute leukaemias, non-Hodgkin's lymphoma, soft-tissue and osteogenic sarcomas, and solid tumours particularly breast, lung, head and neck, bladder, cervical, ovarian, and testicular carcinoma'.

Interestingly - and potentially the reason why it is being studied in relation to aggressive Alopecia Areata - methotrexate has also been used to treat cases of severe, uncontrolled psoriasis which has not responded to other forms of therapy. Psoriasis is another autoimmune disorder but one which affects the skin rather than the hair follicles. In these instances, the drug is usually prescribed as an oral tablet in doses of 10-25mg which are taken once or twice per week, as directed.

Clinical research

The trial, which started in February 2014, is said to be investigating whether methotrexate either 'alone or associated with low doses of prednisone' could be a competent treatment for the more severe types of Alopecia Areata when compared with the effects of a placebo drug.

Test subjects who took part were a mix of men and women aged between 18 and 70 years old. Each had been diagnosed with severe Alopecia Areata that they had been experiencing for more than six months prior to enrollment, despite undergoing forms of treatment which had not worked. These failed treatment types included PUVA or UVB phototherapy, topical corticosteroids (clobetasol propionate), 5% minoxidil, or IV pulse corticosteroids.

Each participant was randomly assigned either methotrexate in 20 to 25 mg doses, or a placebo, which they took once per week for 6 months.

Those who experienced a minimum of 25 per cent hair regrowth after the first 5 months continued taking their assigned pills until the end of the 12 month study. Those who did not respond to their assigned treatment within the first five months were 're-randomized'. They then started to take methotrexate, either on its own or with prednisone 0.3 mg/Kg/day, from month 6 to month 12.

At month 12 details of all participants' hair growth was collated ready to be assessed, along with test subjects' rate of relapse, quality of life and the safety aspects of the drugs.

This assessment is still taking place and researchers aim to complete this part of the study in February 2017. We will bring you an update on their findings on the Belgravia blog as soon as these are released.