Apremilast Gets Central Centrifugal Cicatricial Alopecia Study

When it comes to hair loss conditions, those caused by genetics, autoimmune disorders, problematic hair-styling and cancer treatment tend to receive the most media coverage.

As a result, there are a number of forms which people are significantly less aware of.

Central Centrifugal Cicatricial Alopecia (CCCA) - also known as Follicular Degeneration Syndrome (FDS) - is one of the lesser known types of hair loss, despite it having being found to affect large numbers of women of African descent.

A 2016 study found that, although over 40 per cent of participants presented with this type of scarring hairloss, less than 9 per cent had received a professional diagnosis.

What is Central Centrifugal Cicatricial Alopecia?

CCCA is part of a group of scarring hair loss conditions which, together fall under the umbrella of Cicatricial Alopecia.

Whilst little is confirmed about this enigmatic issue, CCCA is known to be related to inflammation in the hair follicles. It has also been established that the condition almost exclusively affects women of colour with the Afro hair type.

Although certain hair styling practices may contribute to CCCA developing (it is also known as Hot Comb Alopecia in a nod to this), a genetic element is also suspected.

It presents as a patch of hair loss in the centre of the scalp, which - as it progresses - starts to then radiate outward.

Depending on the extent of the damage done to the follicles, hair loss treatment may be possible. A consultation with a specialist is advisable as soon as any signs of shedding occur as this is a time-sensitive problem.

Where the follicles have been destroyed and are no longer capable of normal hair growth, even with pharmaceutical assistance, this can signal permanent baldness in the affected area.

Treating CCCA with Apremilast

The Icahn School of Medicine at Mount Sinai in New York, USA, has announced a Phase 4 clinical study into treating Central Centrifugal Cicatricial Alopecia with Apremilast.

Apremilast is an analgesic drug, generally prescribed in oral form for the treatment of severe plaque psoriasis or active psoriatic athritis in adults.

It is currently only approved for this purpose and goes under the brand name of Otezla in the USA and UK, where it is prescribed by the NHS after receiving marketing authorisation from the European Medicines Agency (EMA). It is FDA-approved in this regard but is not currently MHRA licensed.

Due to its anti-inflammatory properties it has been used as an exploratory treatment for a number of autoimmune disorders, including Alopecia Areata, though these do not yet seem to have progressed past the initial trial stage.

The Mount Sinai interventional study will involve 20 female participants aged 18 years and over, with a professional diagnosis of mild to moderate CCCA. Each will be treated with 30mg of Apremilast, to be administered twice per day for 24 weeks concurrently. After this changes to each volunteer's hair loss, hair growth, symptom severity and quality of life will be assessed.

Serious side effects must be considered

One of the current issues surrounding the already authorised use of Apremilast is the serious side effects users may experience.

In December 2016 directions were sent out to healthcare professionals regarding the risk of psychiatric symptoms, including depression, suicidal thoughts and behaviours, among patients taking Apremilast. This applied whether they had a history of depression or not.

The MHRA issued a general warning in January 2017 regarding this, based on a review of evidence from clinical trials and post-marketing surveillance showing a "causal association between apremilast and suicidal thoughts and suicidal behaviour". It stated that the frequency of these occurring increased from 1 in 1,000 in patients with these conditions who are not being treated with Apremilast, to 10 in 1,000 in those who do take it.

This is obviously something that must be considered when exploring the drug for other potential uses, including that as a treatment for CCCA.

Results from the current trial are expected in October 2019 and findings will be published here on the Belgravia blog as soon as the data is released.