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Clascoterone cream (Winlevi) is the first FDA-approved topical anti-androgen for treating acne in individuals aged 12 and older. It works by targeting androgen receptors in the skin, reducing oil production and inflammation without affecting hormone levels in the body. Clinical trials show it improves acne symptoms more effectively than a placebo, with fewer systemic side effects compared to oral treatments like spironolactone.
Key Points:
- Blocks DHT (dihydrotestosterone) locally to reduce acne.
- Safe for both men and women with no systemic hormonal effects.
- Minimal side effects: mild redness, dryness, or itching.
- Suitable for hormonal acne, including in adults with PCOS.
- Requires a prescription and costs approximately $737.79 without discounts, but savings programs can lower the price.
For those seeking a non-oral, localized acne solution, clascoterone cream offers an effective and safer alternative.
How Clascoterone Cream Works
How It Blocks Hormones
Clascoterone works by targeting androgen receptors in the skin. It competes with dihydrotestosterone (DHT) for binding sites on the pilosebaceous units - essentially the hair follicles and oil glands. By binding to these receptors, clascoterone prevents DHT from activating them. This process reduces the growth of sebaceous glands, lowers excess oil production, and helps calm the inflammation that leads to acne. Studies show it inhibits androgen-driven skin changes by 84%, with a potency three times greater than flutamide and twice that of finasteride. This targeted mechanism makes its effects highly localized and effective.
Topical Application and Local Effects
Unlike oral anti-androgen treatments that affect the entire body, clascoterone is designed to act specifically where it’s applied. After application, the cream is quickly broken down in the epidermis. This rapid hydrolysis produces cortexolone, ensuring the treatment remains localized.
"This novel treatment provides physicians with more options when treating such common skin conditions such as acne. It gives practitioners an anti-androgen treatment, which can be used in males without systemic side effects."
– Carol Sanchez, University of Miami Department of Cutaneous Surgery and Dermatology
Clinical trials indicate that plasma concentrations remain steady by day five, with maximum levels averaging 4.4–4.7 mcg/dL, supporting its localized action.
This localized approach marks a major shift in treatment options. Historically, dermatologists primarily used oral contraceptives and spironolactone to address androgen activity in women, as noted by Dr. Haleh Bakshandeh, founder of Dr B Dermatology in Beverly Hills, California. For men, options were even more restricted.
"This is the first time that we could even consider a 'hormonal' treatment for men... Men do not have to be worried about systemic antiandrogen effects."
– Julie Harper, MD, Dermatology and Skin Care Center of Birmingham
To use, apply about 1 gram (roughly a fingertip amount) to affected areas twice daily to target local androgen receptors.
Clascoterone Mechanism of Action
Benefits and Safety of Clascoterone Cream
Clascoterone cream stands out for its targeted action, with clinical data confirming its effectiveness and a reassuring safety profile.
Clinical Results
Phase 3 trials revealed promising results: treatment success rates with clascoterone cream were 18.4% and 20.3%, compared to only 9.0% and 6.5% with placebo. After 12 weeks, patients using clascoterone saw a reduction in inflammatory lesions by 19.3 to 20.0, while the placebo group experienced a decrease of 12.6 to 15.5. Similarly, non-inflammatory lesions dropped by 19.4 with clascoterone versus 10.8 to 13.0 with placebo.
A meta-analysis of five clinical trials further highlighted its effectiveness, showing that clascoterone nearly triples success rates (relative risk of 2.87) and significantly reduces lesion counts across various patient demographics. It has proven effective regardless of age, gender, ethnicity, or acne severity.
Side Effects and Safety
The side effects of clascoterone cream are mild and manageable. Clinical trials reported similar rates of local skin reactions for both the clascoterone and placebo groups. Common side effects include:
- Redness: 12.2% for clascoterone users vs. 15.4% for placebo
- Scaling and dryness: 10.5% vs. 10.4%
- Itching: 7.7% vs. 8.2%
"Skin reactions including local skin irritation including itching, burning, skin redness or peeling, dryness, scaling, or stinging can occur when you use this medicine." - Mayo Clinic
These reactions can generally be managed by avoiding irritating products, such as medicated soaps, abrasive cleansers, or those with high alcohol content. Patients should also avoid applying the cream to damaged skin, such as cuts, abrasions, or sunburn. Using moisturizers and gently cleansing the skin before application can help reduce irritation. Importantly, no systemic side effects were observed during clinical trials.
Long-term safety data is equally encouraging. In a nine-month study, only 18% of 347 participants reported treatment-related side effects, most of which were mild and localized. This localized safety profile sets clascoterone apart from systemic therapies.
Comparison to Oral Anti-Androgens
Clascoterone cream offers several advantages over oral anti-androgens, particularly in terms of safety and ease of use:
| Feature | Clascoterone Cream 1% | Oral Anti-Androgens |
|---|---|---|
| Administration | Applied directly to the skin twice daily | Taken by mouth daily |
| Systemic Exposure | Minimal – localized action | High – affects the entire body |
| Common Side Effects | Mild skin reactions (redness, dryness) | Menstrual irregularities, dizziness, breast enlargement, nausea |
| Serious Side Effects | None observed in trials | Cardiovascular risks, hyperkalemia, hormonal disruption |
| Suitable for Men | Yes – no systemic hormonal effects | Limited – may cause feminizing effects |
| Pregnancy Considerations | No human studies available | Often contraindicated |
Unlike oral treatments, clascoterone cream avoids systemic complications. For instance, spironolactone - a commonly prescribed oral anti-androgen - can cause menstrual irregularities, dizziness, and breast enlargement. Combined oral contraceptives, another option, carry cardiovascular risks that increase with prolonged use.
A practical example demonstrates the benefits of switching to clascoterone. A 25-year-old woman experienced side effects like dizziness and frequent nighttime urination while taking spironolactone at 100 mg daily. Although her acne improved, these issues were bothersome. By incorporating clascoterone cream into her routine, her dermatologist reduced the spironolactone dose to 50 mg and eventually discontinued it over six months. She maintained clear skin with clascoterone alone, effectively eliminating the systemic side effects.
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How to Use Clascoterone Cream
Using clascoterone cream the right way can help you get the most out of your treatment while keeping side effects to a minimum.
Application Instructions
Follow your doctor’s instructions, which usually means applying the cream twice a day. Start by washing your hands and gently cleansing the affected areas. Make sure the skin is clean and dry before applying. Use about one gram of cream - roughly the size of a fingertip - and spread it evenly over the areas needing treatment. This ensures the cream works where it’s needed most.
Be careful to avoid sensitive areas like your eyes, nose, mouth, or genitals. If the cream accidentally gets into these areas, rinse thoroughly with water. Don’t apply it to broken or irritated skin, such as cuts, scrapes, sunburns, or eczema-affected areas. Also, skip covering the treated areas with bandages unless your doctor specifically advises it.
Timeline and Expected Results
Stick with the treatment for at least 12 weeks to see noticeable results. During the first few weeks - typically 2 to 3 - you may notice some dryness or irritation as your skin adjusts. To minimize discomfort, avoid using harsh skincare products like medicated soaps, abrasive scrubs, or anything with high alcohol content. Instead, opt for gentle, non-comedogenic moisturizers and mild cleansers.
Keep in mind that any leftover cream should be discarded one month after opening or 180 days after it was dispensed. Regular check-ins with your healthcare provider can help you stay on track with your treatment.
When to Contact Your Doctor
If irritation lasts beyond the initial adjustment period, reach out to your doctor. Similarly, if your acne doesn’t improve after 12 weeks of consistent use, schedule a follow-up to discuss your treatment plan.
Before starting clascoterone, let your doctor know about all the medications, skincare products, vitamins, and supplements you’re using to avoid unwanted interactions. Don’t use other acne treatments on the same areas unless your doctor gives you the green light. Staying in touch with your dermatologist ensures your treatment plan remains effective and tailored to your needs.
Getting Clascoterone Cream and Medical Support
Prescription Requirements
Clascoterone cream, known by its brand name Winlevi, is only available with a prescription in the United States [22, 33]. To get this medication, you'll need to consult a licensed healthcare provider. During the consultation, the provider will review your medical history, current medications, and the severity of your acne to decide if clascoterone is the right choice for you [34, 35].
Without insurance, a 60-gram tube of Winlevi costs about $737.79. However, there are ways to reduce this cost. Savings programs like GoodRx, copay cards, or specialty pharmacy discounts can bring the price down to anywhere between $0 and $200 per fill. Additionally, many patients use flexible spending accounts (FSA), health savings accounts (HSA), or health reimbursement arrangements (HRA) to offset the expense.
Oana Health's Telehealth Services
If you'd prefer to skip in-person doctor visits, telehealth provides a convenient solution for accessing clascoterone prescriptions [34, 35]. Oana Health, for example, specializes in telehealth services for hormonal treatments, including managing hormonal acne with a tailored, science-based approach.
The process is simple: a quick five-minute online consultation assesses your medical history and health needs. Based on this evaluation, licensed medical professionals decide if clascoterone cream is a suitable option for you. If prescribed, the medication is shipped directly to your door with free delivery.
Oana Health also offers comprehensive support beyond just acne treatment. Their platform includes ongoing online care, automatic prescription refills, and resources for addressing other symptoms of PCOS, such as unwanted facial hair, hair thinning, insulin resistance, weight concerns, and mental health challenges. By integrating these services into their telehealth model, they make acne treatment more accessible and seamless, ensuring consistent care tailored to your needs.
Conclusion
Key Points
Clascoterone cream stands out as the first approved topical androgen receptor inhibitor for individuals aged 12 and older. By blocking androgen receptors, it tackles the hormonal cause of acne, reducing both sebum production and inflammation. This sets it apart from traditional acne treatments, which often focus on bacteria or skin cell turnover.
Clinical trials back its effectiveness. In two phase III studies, patients using clascoterone 1% showed significantly higher success rates - measured as a ≥2-point drop in acne severity - after 12 weeks compared to those using a placebo. Its minimal systemic absorption eliminates the need for regular lab tests, and it has lower discontinuation rates compared to some topical retinoids. Importantly, its unique mechanism makes it suitable for both male and female patients.
The cream's formulation is designed to reduce dryness and irritation, common drawbacks of other acne treatments. An open-label extension study confirmed its safety and effectiveness for up to 12 months in treating both facial and truncal acne. It can be used alone or alongside other therapies, and it has been shown to improve overall skin texture and tone. These benefits provide a clear path forward for those seeking effective acne management.
Next Steps for Readers
If you're dealing with hormonal acne that hasn’t responded to conventional treatments, it may be time to ask a healthcare provider about clascoterone cream. Since it’s available by prescription, a licensed professional can determine if it’s the right option for your needs.
Oana Health simplifies the process with a quick five-minute online consultation. Their licensed professionals can prescribe clascoterone cream and deliver it to your home at no extra cost. In addition to acne treatments, Oana Health offers broader hormonal health support, including help with conditions like PCOS. Their services include automatic prescription refills, ongoing care, and resources for managing issues such as unwanted facial hair, hair thinning, and insulin resistance. One patient shared her experience with Oana Health's telehealth services:
"Oana's telehealth service is fantastic! It's helped manage my insulin levels and reduce excess hair growth I was experiencing due to PCOS. I'm recommending this to all my friends with PCOS." – Victoria A.
Skip the hassle of in-person visits and endless research. With telehealth options like Oana Health, you can access proven treatments like clascoterone cream from the comfort of your home while receiving personalized care tailored to your needs.
FAQs
What makes clascoterone cream different from oral anti-androgen treatments for acne?
Clascoterone cream is a topical treatment designed to act directly on the skin. It works by blocking androgen receptors, which helps curb oil production and ease inflammation right at the source. This approach specifically targets acne without influencing the rest of the body.
On the other hand, oral anti-androgens like spironolactone or hormonal contraceptives work systemically, altering hormone levels throughout the entire body. While these oral options can be effective, they often come with a higher chance of widespread side effects. Clascoterone cream provides a more localized solution, offering targeted acne care with fewer systemic concerns.
How can I save money when purchasing clascoterone cream?
If you're looking to cut down the cost of clascoterone cream, there are a few strategies worth exploring. Manufacturer savings programs, co-pay assistance, and pharmacy discount cards can significantly reduce your out-of-pocket expenses. In some cases, these programs can bring the cost down to as little as $20 to $90 per prescription.
Another smart move is to shop around and compare prices at different pharmacies. Some pharmacies offer better deals or participate in discount programs that can lower the price even further. Don't hesitate to check with your healthcare provider or pharmacist about savings options that might work for you.
Can I use clascoterone cream with other acne treatments?
Yes, clascoterone cream works well with many other topical acne treatments, such as tretinoin and antibiotics. Studies confirm that it stays effective and stable when used alongside these medications. However, pairing it with certain products, like azelaic acid, might heighten the likelihood of skin irritation. It's always a good idea to check with your healthcare provider before introducing new treatments to your regimen to ensure optimal results and reduce the chance of side effects.
