Acne is one of the most common skin conditions which can affect people across all ages around the world. Although many factors contribute to acne, hormones are one the primary drivers of breakouts. As the understanding of the influence of hormones in acne has grown, so too has the development of targeted treatments. One example is Clascoterone which has shown promise in addressing hormonal acne by targeting androgen activity in the skin. Amongst these novel treatments is Clascoterone (available under brand name Winlevi®). In this article, we’ll explore the science behind Clascoterone in hormonal acne and how this led to Winlevi cream. We’ll also review how Winlevi Clascoterone cream works, what it does, benefits, limitations and how it compares to alternatives.
What Role Do Hormones Play in Acne?
Hormones play a significant role in acne, particularly during periods of hormonal fluctuation. This includes puberty, menopause, menstruation, pregnancy, stress or conditions like polycystic ovary syndrome (PCOS) . Androgens, a group of hormones that includes testosterone, are especially influential in acne development. These hormones stimulate sebaceous glands to produce more sebum, or oil. This can then lead to clogged pores and create an environment where acne-causing bacteria thrive. In people with high androgen levels or skin highly sensitive to androgens, this can cause inflammation and persistent breakouts. Research has led to a deeper understanding of how we can control the skin’s oil production by blocking androgen activity. This then paved the path for developing topical treatments that can directly target androgen receptors in the skin.
How Does Clascoterone Work on Acne?
Clascoterone is the active ingredient in Winlevi cream and addresses hormone-driven acne by directly targeting androgen activity in the skin. It works on acne by specifically blocking androgen receptors in the skin to reduce sebum production and inflammation. By binding to these androgen receptors in the sebaceous glands, Clascoterone prevents androgens from activating them. This then effectively reduces sebum output locally in the skin. Since it works locally, it doesn’t affect hormone levels in the body unlike systemic treatments like oral Spironolactone. Clinical studies show that it is effective in treating both inflammatory and non-inflammatory acne lesions with minimal systemic side effects.
What is Winlevi Cream?
Winlevi® (Clascoterone 1%) is the first FDA-approved topical cream that targets androgen receptors in the skin to manage acne. It received FDA approval in August 2020. Winlevi’s approval was based on clinical trials. These demonstrated its effectiveness in reducing both inflammatory and non-inflammatory acne lesions, especially in moderate to severe cases. It is licensed specifically for the topical treatment of acne vulgaris in individuals aged 12 and older. The key benefits of Winlevi® Clascoterone Cream include:
- Direct Action: By working directly on the sebaceous glands in the skin, Winlevi® reduces oil production and inflammation. This mens it acts at the source of acne formation.
- Local Effects: Its topical nature minimises the risk of systemic side effects commonly seen with oral anti-androgens.
- Versatile: Clinical studies on Winlevi® have demonstrated positive outcomes in reducing both inflammatory and non-inflammatory lesions in moderate acne cases.
- Improvement in Skin Clarity: With reduced sebum production, some users also experience improved skin texture and tone.
Winlevi® is a prescription only medicine which may not be appropriate for every one. It requires a specialist assessment. Dermatologists may recommend it for individuals experiencing moderate hormonal acne, particularly those with recurrent breakouts along the jawline, chin and cheeks. Although it is normally a twice a day treatment that you apply on affected areas, your healthcare provider will tailor the instructions based on your individual needs.
Potential Risks & Side Effects of Clascoterone
Although most people tolerate Winlevi well, like any medicine there are some side effects. Who gets these and the severity varies from person to person depending on several factors including skin sensitivity. The most common side effects of Winlevi Clascoterone cream are:
- Skin Irritation: This includes redness, dryness and itching especially when first starting treatment.
- Risk of Hyperpigmentation: People prone to post-inflammatory hyperpigmentation such as those with darker skin tones may experience dark marks following irritation.
- Initial Increase in Breakouts (Purging): As with most acne treatments, some experience an initial flare up in acne. These usually subside as the skin adjusts to the new therapy.
Beyond these risk factors its worth remembering that although topical treatments reduce the risk of systemic side effects, there may still be a small number of people who develop these anyway. This is why its important to only undertake this treatment under careful supervision of a medical provider who can ensure your safety. Allergies are also a potential risk and your doctor will advise on how to check for this before providing your treatment. Additionally, like many prescription medications, Winlevi (clascoterone cream 1%) is not suitable for everyone this includes people with:
- Hypersensitivity Reactions: Those with known hypersensitivity to Clascoterone or any of the cream’s other ingredients should avoid using Winlevi, as this can lead to allergic reactions or skin irritation.
- Pregnancy and Breastfeeding: Although topical Clascoterone doesn’t absorb into the bloodstream in significant amounts, its effects during pregnancy and breastfeeding have not been thoroughly studied. As such it is best to avoid using it in these situations.
- Skin Irritation and Sensitivity: People with particularly sensitive skin or those prone to skin barrier issues may need to avoid or use Winlevi under closer supervision.
- Interaction with Corticosteroids: As clascoterone has a corticosteroid-like structure, concurrent use with topical steroids should be closely monitored by a healthcare provider. This is to avoid skin thinning or other local skin reactions.
Is Winlevi® Available in the UK on the NHS?
Despite its popularity in the US, Winlevi is not yet available on the UK market. As of now, the cream has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body responsible for ensuring the safety and efficacy of medications in the UK.
Since Winlevi is not approved in the UK, it is not currently available through the NHS. Even if it does gain MHRA approval, there will likely be a further assessment by the National Institute for Health and Care Excellence (NICE) to determine its cost-effectiveness. NICE’s recommendations influence which treatments are accessible through NHS prescriptions.
Alternative Treatments to Winlevi® for Hormonal Acne
The main benefit of Winlevi is that it is a topical anti-androgen that can provide a more precise approach to reducing androgen activity. However, because it only affects skin-level receptors, Winlevi may be less effective for those with significant hormonal imbalances or high androgen levels. Additionally, Winlevi might not suitable for treating less hormone driven types of acne, post inflammatory hyperpigmentation or erythema or severe cystic acne. It might also not effectively address scarring from past acne. There are a number of existing acne treatments that serve as good alternatives to Winlevi. Below we explore the general benefits and limitations of each:
- Oral Contraceptives: Compared to Winlevi, these work systemically to lower androgen levels throughout the body. This broad approach can be beneficial for those with widespread hormonal imbalances. However these come with potential side effects like mood changes and an increased risk of blood clots.
- Spironolactone (Oral and Topical): Like oral contraceptives, oral spironolactone works systemically to reduce androgen activity and is effective for acne influenced by hormonal imbalances. However, it also carries potential side effects, such as dizziness and increased urination. Topical spironolactone, on the other hand, offers a localised treatment similar to Winlevi. This potentially reduces side effects while directly targeting skin-level androgen activity. However, both forms may vary in effectiveness depending on individual hormonal profiles and are currently not licensed for use in acne so are only available as unlicensed or off-label treatments.
- Antibiotics: Available in both topical and oral forms, these can help manage acne by reducing bacterial growth and inflammation. Compared to Winlevi, antibiotics do not address androgen activity but can be effective for inflammatory acne. Oral antibiotics work systemically and may have side effects, such as gastrointestinal issues. Topical antibiotics target the skin directly with fewer systemic effects. However, long-term use of antibiotics is not typically recommended due to the risk of antibiotic resistance.
- Roaccutane (Isotretinoin): This is powerful oral retinoid is normally prescribed for severe acne that hasn’t responded to other treatments. Unlike Winlevi, which targets androgen activity at the skin level, Roaccutane works by reducing sebum production and shrinking sebaceous glands. This can lead to long-lasting improvement in acne. However, Roaccutane comes with significant potential side effects, including dryness, mood changes and birth defects. As such it requires careful monitoring during use.
- Topical Retinoids: Unlike Winlevi, topical prescription retinoids such as Tretinoin and Adapalene do not directly target androgen activity but instead focus on promoting skin cell turnover, reducing inflammation and preventing clogged pores. These treatments are effective for managing mild to moderate acne but may not address the hormonal triggers of acne as Winlevi does. They can however help with scars, texture and post inflammatory hyperpigmentation.
Each person’s skin and hormonal needs are unique, and the most effective acne treatment sometimes involves a combination of different approaches. Consulting with a medical provider can help determine the best treatment path for you. This may include a mix of topical treatments, oral medications and/or lifestyle adjustments.
Winlevi cream is an exciting addition to a new class of acne treatments that can specifically targeting androgen receptors in the skin and offering a solution for hormonally driven acne. Although studies are promising, Winlevi® is not suitable for everyone and is not available in most of the world (including the UK) yet. Regardless of availability, there are a number of existing acne treatments that are also effective in hormone-driven acne. You should always see a medical professional to help determine which treatment (or combination of treatments) is best for your skin concerns, medical profile and goals. Finally, there are currently some promising results for the role of Clascoterone in androgenetic hair loss due to its topical androgen-blocking effects. This is further evidence of the ongoing advances and enthusiasm for identifying in topical and more targeted treatments in Dermatology.