Key takeaways:
Acne is a common skin condition that can be treated in many ways.
Winlevi (clascoterone) is the first new type of acne medication that’s been FDA-approved in 40 years.
There are many ways to save on Winlevi. If you’re eligible, a manufacturer savings card can help you access Winlevi for as little as $20 per month.
Save on related medications
Acne is a skin condition that impacts people of all ages. There are many different acne treatments available, both over-the-counter (OTC) and by prescription. One of the newest acne treatments available is a hormonal medication that’s applied to your skin. It’s called Winlevi (clascoterone).
Until Winlevi was approved, there hasn’t been a new FDA-approved way of treating acne since 1982. Winlevi provides a new approach to treating acne, and it may be a helpful option for people who haven’t been successful with other acne treatments. But who should use it? How does it work?
Read on to learn more about Winlevi and how it compares to other available acne medications.
What is Winlevi?
Winlevi is a prescription acne cream that contains the medication clascoterone. It’s the first topical treatment option in a group of medications called androgen receptor inhibitors. This means it’s a type of hormonal medication, so it can treat hormonal acne.
How do you use Winlevi?
In most cases, Winlevi should be used twice daily (morning and evening). When you apply it to your skin, you only need to apply a thin layer. It’s helpful to wash and dry your face before applying Winlevi.
But you should avoid getting Winlevi in your eyes, mouth, or any open cuts or scars. This is important to help avoid irritation. You should also avoid using Winlevi with products that might dry your skin, like medicated cleansers.
And after you’re done applying Winlevi to your skin, make sure to wash your hands thoroughly. This is important to make sure you don’t accidentally get the medication in your eyes, mouth, or on objects around you.
Once you’re finished applying the cream and washing your hands, you can store Winlevi at room temperature between doses.
How does Winlevi work?
Your skin producing large amounts of sebum is a common cause of acne. Sebum is an oily, waxy substance made by sebaceous glands, which are small organs found throughout your skin. Normal amounts of sebum can help protect your skin from things like bacteria and damage from sunlight. But too much of it can contribute to acne.
It’s not fully understood how Winlevi works, but it’s thought to work by interacting with androgen receptors (chemical binding sites) in sebaceous glands in your skin.
This is because Winlevi is a type of androgen receptor inhibitor. Androgens are a family of hormones, and testosterone is part of this family. Sebum is produced when hormones, like testosterone, bind to these receptors. Winlevi helps block these hormones from binding to androgen receptors, and this lowers sebum production to help control acne.
Who can use Winlevi?
Winlevi is approved for people ages 12 and older. It’s unknown if Winlevi is safe and effective for people younger than 12.
And even though it targets hormones like testosterone, Winelevi may be used for both men and women. It works similarly for males and females and has similar side effects in both. However, there’s no information on the risk or side effects of using Winlevi in women who are pregnant or nursing.
Do you need a prescription for Winlevi?
Yes, Winlevi requires a prescription from a healthcare provider. In-person and telehealth providers can prescribe acne medications like Winlevi.
It’s recommended to talk to your healthcare provider if you believe Winlevi might be right for you.
Can Winlevi be used for more than just acne?
No. Currently, Winlevi is only approved for the topical treatment of acne. This means you should only apply it to your skin, and you shouldn’t consume or inject it.
Winlevi is the only topical acne medication that’s an androgen receptor inhibitor. Other androgen receptor inhibitors — like enzalutamide (Xtandi), bicalutamide (Casodex), and apalutamide (Erleada) — are oral medications used to treat certain types of prostate cancer.
What are some alternatives to Winlevi?
If Winlevi doesn’t work for you, there are alternative acne treatments available that might.
Some other medications also target hormones that cause acne. However, these are oral medications — not topical ones. Medications that treat hormonal acne in women include oral birth control pills and spironolactone.
Examples of other, non-hormonal acne medications that may also help include:
Salicylic acid
Topical antibiotics like clindamycin and erythromycin
Topical retinoids like tretinoin (Retin-A, Atralin, Avita), adapalene (Differin), and tazarotene (Tazorac, Avage)
How is Winlevi different from other acne creams?
Winlevi is the only acne cream that targets hormones that cause excess sebum and acne. It’s also the first new FDA-approved way to treat acne in 40 years.
Plus, there are several other types of acne creams that work in different ways. This includes medications that kill bacteria, prevent your pores from clogging, and reduce inflammation. Many of these medications are also available in gels, lotions, and foams, but Winlevi is only available as a cream. Some acne creams — like benzoyl peroxide and salicylic acid — are available OTC.
How effective is Winlevi compared to other topical acne medications?
Winlevi showed improvements in acne and clearer skin after 3 months of treatment.
There are currently no studies that directly compare Winlevi to other topical acne medications. Clinical studies for Winlevi compared the cream to a placebo (a cream with no medication in it). But other acne medications like adapalene gel and tretinoin also showed improvements in acne after 3 months of treatment in different studies.
If you’ve tried other topical acne medications and have had limited success, there’s a chance Winlevi may work for you. This is because Winlevi works differently than other topical acne medications, so it may tackle the root cause of your acne better than other options.
What side effects are associated with Winlevi?
Like many other topical acne medications, Winlevi has a few possible side effects. Winlevi’s most common side effects include skin redness, itching, and peeling.
And as discussed, Winlevi may block the production of certain types of hormones. If your body doesn’t make enough of these hormones, you may also experience symptoms. This is called adrenal insufficiency. This risk is generally higher if you use Winlevi to cover large parts of your body. It’s also higher if you cover treated areas of skin with tight bandages or very snug clothing.
Symptoms of adrenal insufficiency include:
Weakness or tiredness
Joint pain
Abdominal pain
Weight loss
Nausea
Vomiting
Diarrhea
It’s recommended to contact your healthcare provider if you’re experiencing any symptoms listed above that are causing pain or discomfort.
Are Winlevi’s side effects common among other topical acne medications?
Yes. Winlevi’s side effects of skin irritation and redness are similar to other acne medications available. However, other topical acne creams don’t have a risk of adrenal insufficiency.
How to save on Winlevi
There are ways to save on Winlevi, which is only available as a brand-name medication. GoodRx can help you navigate copay savings cards to save money on your prescription.
Save with a copay savings card. If you have commercial insurance, you may be eligible to pay as little as $20 for Winlevi using a savings card from the manufacturer.
Is Winlevi already available?
Yes, Winlevi was approved by the FDA in 2020. It’s currently available as a 60-gram tube of 1% cream. It may be available at your local pharmacy. Consider calling ahead before filling your prescription to make sure your preferred pharmacy has it in stock.
The bottom line
Many people — especially adolescents — experience acne at some point. There are several treatment options available, both OTC and by prescription. Winlevi offers a new method of treating acne and can potentially help people who don’t achieve clearer skin with other medications. But like many other acne creams, Winlevi can cause skin irritation and may take up to 3 months to see positive results.
Why trust our experts?
References
Food and Drug Administration. (2020). Drug trial snapshot: WINLEVI.
Hebert, A., et al. (2020). Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne. JAMA Dermatology.
Hoover, E., et al. (2021). Physiology, sebaceous glands. StatPearls.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms and causes of adrenal insufficiency & Addison's disease.
Picardo, M., et al. (2009). Sebaceous gland lipids. Dermato-Endocrinology.
Piskin, S., et al. (2007). A review of the use of adapalene for the treatment of acne vulgaris. Therapeutics and Clinical Risk Management.
Sun Dermatology. (n.d.). WINLEVI® co-pay program.
Sun Pharmaceutical Industries. (2021). Winlevi [package insert].
Sutaria, A. H., et al. (2021). Acne vulgaris. StatPearls.
You & Your Hormones. (2021). Testosterone.
