A Phase 4 clinical trial hopes to demonstrate that the anti-inflammatory properties of the drug apremilast can help people with a permanent form of hair loss known as Central Centrifugal Cicatricial Alopecia (CCCA).
CCCA is a form of scarring, or cicatricial alopecia
, which radiates out from the centre of the scalp and is most commonly experienced by women of colour. Relatively little is known about this form of hair loss,
other than the fact that the hair follicles are often destroyed due to inflammation, and it tends to run in families.
A 2017 study found that almost half of African American women
were affected, whilst it was recently revealed that Black women have a higher risk of CCCA and uterine fibroids
, which were discovered to be linked.
Apremilast, which is also known by the brand name Otezla, is an oral medication currently used to treat a number of immune-related diseases, including plaque psoriasis and psoriatic arthritis, in tablet form.
It has also been - and is still being in the second instance - investigated in relation to treating Alopecia Areata
- an autoimmune disorder which causes sudden patchy hair loss - and as a potential treatment for Frontal Fibrosing Alopecia
which is currently untreatable.
Though CCCA is not a form of autoimmune alopecia
, the team of researchers at New York's respected Icahn School of Medicine at Mount Sinai hospital believe it may treat Central Centrifugal Cicatricial Alopecia in mild to moderate cases.
Latter stages of clinical trial process
The Mount Sinai trial registration
announced it was now recruiting 20 test subjects to take part in this new study, on 10th May 2018. It is hoped that the trial proper will start on 31st May 2018, and the estimated end date is currently given as 15th October 2019.
The single-centre, 24 week trial will only involve female participants aged 18 years and over, who are of African descent.
According to the researchers' stated aims, they believe 'the anti-inflammatory properties of apremilast may play a role in the decreasing scalp inflammation in patients with CCCA and may prevent further hair loss and potentially induce hair regrowth in patients with mild to moderate disease'.
The fact that the trial is now in its Phase 4 stage indicates that it is far along in the development process
. Usually once Phase 3 has been successfully completed, a new drug can be put forward for licensing and approval by the relevant medical regulatory boards - such as the MHRA and FDA
. If this is granted, it can then be made available for prescription use, and Phase 4 indicates the post-marketing monitoring of the medication by users.
If apremilast does prove a safe and effective solution for CCCA, it would be a significant breakthrough given the prevalence of the condition and the fact that it currently has no effective treatment options.
We shall be following the outcome of this exciting trial with interest and reporting the latest information as soon as it is released, here on our dedicated hair loss blog.