Acne remains one of the most common skin conditions in both teenagers and adults. There are a wide variety of treatment options which commonly include over the counter products like benzoyl peroxide, retinoids, antibiotics and hormonal medicines. Recently, the new drug Winlevi cream has been making waves as the first new topical acne treatment in 40 years with a different mechanism of action. This topical anti-androgen works differently from most traditional acne treatments. It was initially available in the USA but after recent approval by the MHRA, patients Winlevi is now available in the UK. In this article we’ll quickly review how Winlevi works, how to get it in the UK and alternatives.
What is Winlevi?
Winlevi is the brand name for clascoterone cream which a topical androgen receptor inhibitor. It blocks the effect of androgen hormones such as testosterone and dihydrotestosterone (DHT) within the oil producing sebaceous glands of the skin. In acne, these hormones drive excess sebum (oil) production which leads to bacterial overgrowth, pore clogging and inflammation. By targeting this pathway directly in the skin, Winlevi offers a new approach that differs from retinoids or antibiotics which instead target cell turnover, pore clearing and bacterial overgrowth. For a full explanation of how clascoterone works in hormonal acne, check out our detailed Winlevi article.
What Does the Evidence Show?
Clinical trials in the US and Europe showed that Winlevi reduced both inflammatory and non-inflammatory acne lesions in comparison with a placebo. Most participants tolerated it well with the most common side effects being mild skin irritation and redness. However long-term real world data is still lacking which is understandable as this is a new drug. There are also no large head-to-head studies directly comparing clascoterone with other acne treatments such as retinoids, benzoyl peroxide or hormonal medicines. As such, its best to view Winlevi as a potentially useful addition rather than a replacement for existing treatments. Ultimately, acne differs from person to person and there’s no signal approach that works for everyone so any new treatments can only help increase patient choice.
Is Winlevi Available in the UK?
In January 2025, the MHRA approved Winlevi 10mg/g cream for the treatment of acne vulgaris in patients aged 12 and over. It is a prescription-only medicine, so you can’t buy it over the counter as it needs a prescription from a medical provider. At present, availability across the UK is still developing as the manufacturer rolls out supply chains and pricing negotiations continue. This means that although it has approval, it may not yet be routinely available in pharmacies. At the moment it is undergoing assessment by the National Institute for Health and Care Excellence (NICE) to determine its cost-effectiveness. NICE’s recommendation will determine whether Winlevi will be accessible through the NHS and the eligibility criteria in the UK. There are also a number of online pharmacies and private dermatology clinics that provide it. At City Skin Clinic, we do not currently offer Winlevi because we continue to focus on personalised topical acne treatments which includes an alternative androgen blocker where appropriate.
How Can You Use Winlevi?
Under its UK license, patients apply Winlevi directly to the affected areas of skin as a thin layer. The recommendation is twice daily usage but the prescribing clinician will determine this. Dose and frequency may also differ for children aged 12-18 and adults over 65 years old. The initial treatment duration in trials was 12 weeks. The treating doctor can then review whether to continue after. You should only use Winlevi on clean, dry skin and avoid it on broken or eczematous areas. Aside from this, patients will likely just need to continue with a gentle skincare routine and daily sunscreen. You should avoid combining Winlevi with strong over-the-counter acne products unless specifically your treating doctor recommends otherwise.
Who is Winlevi suitable for?
Winlevi may suit patients with persistent inflammatory acne who cannot tolerate or do not wish to use systemic anti-androgen therapy (e.g. oral Spironolactone). Because Winlevi works as an anti-androgen, it is not suitable for use in pregnancy or breastfeeding as we do not have long-term safety data for these groups. Nor is it suitable for those with high potassium, liver or kidney disease. Also, it may not be appropriate for people with severe nodulocystic acne who may be better off with isotretinoin. As with any new medicine, there are still questions about cost, access and how it performs outside of trials.
Safety & Side Effects
Most people generally tolerate Winlevi but, like all prescription medicines, it can cause side effects. The most common are local skin reactions such as redness, burning, stinging or dryness at the site of application. These are usually mild and tend to improve as the skin adjusts. Rarely, some patients may experience worsening irritation or an allergic reaction that requires discontinuation.
A few less common side effects were also identified during clinical trials and long-term safety studies. These included evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, though this was rare and typically reversible once treatment was stopped. Other rare side effects included polycystic ovaries and alterations in hair colour. Winlevi should only be used under medical supervision with regular follow up. Patients should report any unexpected symptoms including menstrual, skin or any other health changes to their doctor.
Alternatives to Winlevi in the UK
Whilst Winlevi is an interesting and very exciting development, it may not be suitable or effective for everyone. This is because acne is a multi-factorial skin condition and optimal treatment varies from person to person. The below are some of the most popular acne treatment alternatives that also have a strong evidence base and safety profile:
- Retinoids: Prescription retinoids like tretinoin and adapalene help to prevent clogged pores and reduce inflammation. Oral retinoids such as roaccutane may be used for severe acne and can also help regulate oil production. In addition to treating acne, retinoids can also help with texture, scars and post inflammatory hyperpigmentation.
- Benzoyl Peroxide: This over the counter topical ingredient reduces numbers of the bacteria which causes inflammation and acne.
- Azelaic Acid: Available as a topical treatment over the counter in strengths of up to 10% and by prescription for up to 20%. Azelaic acid is suitable for sensitive and even rosacea skin. It helps clear pores and reduce inflammation. Azelaic acid can also smooth texture, reduce redness and fade post-inflammatory pigmentation.
- Antibiotics: Oral and topical antibiotics can help tackle inflammatory acne. Topical antibiotics like clindamycin may be used alone or compounded with other acne treatments like tretinoin or adapalene.
- Hormone Modulators: Drugs like spironolactone or the combined oral contraceptive pill can be very effective in female patients with hormonal acne. They work by balancing the androgen to oestrogen levels. Topical Spironolactone works similarly to Winlevi in that it blocks the effects of androgens on the skin.
Winlevi is now MHRA-approved in the UK and may provide an additional option for some patients with acne. However, availability and access is still evolving. Long-term data will provide further information on the longevity of results and comparison with existing acne treatments. If you have severe or persistent acne, its best to seek medical help straight away. This will help you start on the best treatment protocol for your skin hence reducing the risk of scarring, post acne marks and side effects.
At City Skin Clinic, we do not provide Winlevi (clascoterone). We do however offer a variety of skincare treatments that can help treat hormonal acne. Check out our online skin clinic which offers custom acne treatments using ingredients like Tretinoin, azelaic acid and spironolactone where appropriate. Start a virtual consultation with one of our doctors and take your first step towards better skin.
This article is intended for general informational purposes only and is not a substitute for medical advice, diagnosis or treatment. Always consult a qualified medical provider for any medical concerns or questions you might have.
