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Phase 4 Frontal Fibrosing Alopecia Trial For Apremilast


A dermatology clinic in the United States is trialling an established psoriasis drug on people with a rare form of hair loss.

At present, those with Frontal Fibrosing Alopecia (FFA) – a condition more common in women than men and which is categorised as a type of Scarring Hair Loss or Cicatricial Alopecia – are not very well served when it comes to treatment. This is because their hair follicles have become severely damaged as a result of inflammation and the net result is usually a wide band of smooth, bald skin around the whole of the frontal hairline.

Example of Frontal Fibrosing Alopecia

An Example of Frontal Fibrosing Alopecia

Currently, people presenting with FFA have no hair loss treatment remedies open to them, however, in some cases a hair transplant may be possible. There are many factors involved in deciding when surgery is an appropriate course of action, however, so cases are always judged on an individual basis by specialised surgeons – there is no general rule.

New uses for existing medications

Research into new uses for existing products is usually initiated by larger organisations and universities, but it is not uncommon for smaller organisations to conduct clinical trials. This appears to be the case with a registration on the clinicaltrials.gov website from Washington State-based Bellevue Dermatology, whose website describes it as a general dermatology practice with experience in diagnosing and treating psoriasis, skin cancer and other skin, hair and nail issues. It is being supported by a New Jersey-based biotech company named Celgene.

Bellevue’s trial listing suggests that the investigation into the psoriasis drug Apremilast for people with Frontal Fibrosing Alopecia is at an advanced stage, as it is recorded as a Phase IV trial, which usually means that the drug has been proven and is available for general use. In fact, a Phase IV trial is often known as “postmarketing surveillance”, with a focus on the long-term monitoring of the drug after it has been released.

This does not really tally with the description of the trial in which the clinic states it is looking to start recruiting 20 individuals with Frontal Fibrosing Alopecia, each of whom will be treated with Apremilast. The clinic says that each enrolled patient will be evaluated by a skin specialist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index.


Writing in its application, the clinic states: “Evidence suggests that timely and effective management can prevent the permanent loss of hair. Unfortunately, most common treatments have been disappointing with poor efficacy or high risk profile. The availability of a safe effective treatment for this disease remains an unmet need.”

Other interest from New York

Bellevue is not the only institute with an eye on using Apremilast on conditions that lead to hair loss; the widely-respected Icahn School of Medicine at Mount Sinai in New York has been working on a trial in which the drug is used on people with Alopecia Areata, the autoimmune disorder which leads to sudden, patchy hair loss anywhere on the scalp. Its goal was to recruit 30 people with Alopecia Areata or one of its more severe sister phenotypes, Alopecia Totalis and Alopecia Universalis, to see how Apremilast taken in pill form affected hair growth.

As was noted at the time that trial was announced, no explanation as to why the Icahn School of Medicine thought of trying a psoriasis drug to regrow hair was given, although it seemed likely that they were guided by the findings of several other studies in which a janus kinase inhibitor drug named tofacitinib – brand name: Xeljanz – also used to treat certain types of psoriasis, had led to hair growth as a side effect. For its part, Bellevue says that Apremilast “is a novel phosphodiesterase 4 inhibitor currently FDA approved to treat psoriasis and is under investigation for other auto immune conditions.”

The hair loss experts at the Belgravia Centre diagnose a wide variety of different conditions every day, many of which can be treated, including scalp-only Alopecia Areata. Some are certainly harder to treat, and the ambitions of Bellevue are therefore to be applauded. Given the multitude of different but relatively similar conditions that can lead to hair shedding, it always makes sense to seek expert help, as self-diagnosis can be deeply flawed.

circ - The Belgravia Centre Hair Loss Clinic - For Men and WomenThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.

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