This year, clascoterone (brand name: Winlevi) has been approved by The United States Food and Drug Administration (FDA) for treatment of acne in the US. In the UK, there are several options for the management of acne, including topical preparations and oral antibiotics. In this post, I will review clascoterone and compare it to other treatments available in the UK. I will also talk about any possibility of clascoterone cream reaching the UK.
What is clascoterone?
Clascoterone cream (Winlevi) is a new prescription-only cream for the treatment of acne approved in the US at the end of August 2020. Winlevi comes in the form of cream, which is applied twice a day.
In the US, clascoterone is restricted to the treatment of acne in patients 12 years and over.
Is clascoterone effective in the treatment of acne?
The approval decision for drug licensing comes from information gathered during clinical trials. The primary evidence comes from the clinical trial involving 1440 patients with acne vulgaris. Patient applied either clascoterone (Winlevi) twice a day for 12 weeks or cream, which did not contain any active ingredients (patients not aware which treatment they were given).
At the end of the 12-week trial, the treatment was successful in 18.4% and 20.3% (different age groups).
Clascoterone: possible side effects
Like with many other topical creams and gel for the treatment of acne, clascoterone can cause local irritation of the skin – itching, redness, dryness and scaling, all of which are reported as a common side effect associated with the treatment.
Overall, the side effects experienced by patients were mild and similar to patients who used a ‘dummy’ cream.
How does clascoterone work to stop acne?
Clascoterone cream is androgen receptor inhibitor.
What does it mean?
Androgens are a class of male ‘sex’ hormones, which contribute to the development of acne symptoms. Two androgens testosterone (T) and dihydrotestosterone (DHT) are produced in the skin and attach (bind) to receptors (Zouboulis, 2004) and consequently stimulate sebaceous glands to produce sebum, an oily substance. Sebum’s role is to lubricate the hair and skin. Overproduction of sebum can lead to blockage of hair follicles, to which sebaceous glands are connected to. Consequently, a plug is formed in the follicle, which causes symptoms of acne – blackheads or whiteheads.
Children get symptoms of acne during puberty as testosterone production rises during this time.
Clascoterone stops the ‘attachment’ of hormones to the receptor found in the skin and therefore reduce the production of sebum.
What are the acne treatment options in the UK?
Broadly speaking, acne is treated with topical products (gels, creams, and lotions) and oral antibiotics. Mild to moderate acne is usually managed with skin products. Topical products for the treatment of acne may contain the following drugs:
- benzoyl peroxide, which is also available over the counter, without a prescription (brand name: Acnecide)
- retinoid alone or in combination with benzoyl peroxide or an antibiotic
- Topical antibiotic, which should always be prescribed in combination with another active ingredient, for example, benzoyl peroxide (see Duac Once Daily gel for acne). Addition of second active ingredient, such as benzoyl peroxide reduces the risk of bacterial resistance, which makes antibiotics less effective in the treatment of infectious conditions.
Patients who fail to respond to topical treatment may be recommended to take and additional oral antibiotics. Treatment of acne with oral antibiotic is usually limited to a maximum of 3 months. Optionally, some women may be offered an oral contraceptive for the treatment of acne, such as Dianette.
New cream for acne – how does it differ from other topical treatments for acne?
None of the drugs listed above affects hormones which contribute to acne symptoms. The mainstream treatment of acne in the UK is the use of combination skin products and oral antibiotics. Clascoterone offers a new approach to the treatment of acne.
Can you get clascoterone cream in the UK?
The approval of clascoterone (Winlevi) for the treatment of acne applies only to the US. Pharmaceutical companies need to apply for a separate license to the European Medicines Agency (EMA) if they wish to market their drug in Europe. At the moment clascoterone is not listed by EMA under medicines which are under evaluation.
Clascoterone for hair loss
The company which developed clascoterone for the treatment of acne, Cassiopea, is in the process of trialling clascoterone solution 7.5% for the treatment of hair loss (androgenetic alopecia/AGA). The principle behind the treatment of hair loss has a similar mechanism to one of acne. Reduced effect of dihydrotestosterone (DHT) minimises thinning and shortening of a hair growth cycle and therefore helps to prevent baldness. Phase III clinical trials involving clascoterone solution 7.5% for the treatment of hair loss has not started yet.
Clascoterone cream is a novel, first in the class treatment of acne. It offers a new approach to acne treatment, which is favourable since clascoterone cream does not contain antibiotics. It would be reasonable to expect post-launch information on the effectiveness of clascoterone cream from a larger population of patients. Although clascoterone cream is not available in the UK or Europe, it would be a great addition to drugs used in the treatment of acne.
Zouboulis CC. Acne and sebaceous gland function. Clin Dermatol. 2004;22(5):360–366. doi:10.1016/j.clindermatol.2004.03.004 Available at https://doi.org/10.1016/j.clindermatol.2004.03.004 Accessed on 26/11/2020