CLASCOTERONE 1% – A NEW OPTION FOR TREATING ACNE
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General Information
Winlevi (clascoterone 1%) is a new acne treatment topical medication approved by the FDA in August 2020 based on the results of the WINLEVI clinical trials for treating acne in individuals aged 12 and older.
Clascoterone belongs to the group of anti-androgen medications. It works by binding to androgen receptors in sebaceous glands and hair follicles, limiting the secretion-stimulating and inflammatory effects of DHT. This helps reduce sebum production and inflammation at the site of application. Winlevi’s approval marks a breakthrough in acne treatment. This topical medication offers a new approach compared to traditional oral antibiotics, topical treatments, or active ingredients like BPO, Adapalene, and Tretinoin, which primarily target bacteria. Clascoterone 1% inhibits sebum overproduction, which creates the oily environment that fosters acne-causing bacteria (C. acne).
In clinical trials, Winlevi demonstrated effectiveness in reducing inflammatory acne lesions and was well tolerated when applied twice daily. Avoid applying it to thin-skinned areas around the eyes, mouth, and mucous membranes.
Advantages of Winlevi
(Anti-androgen topical) compared to oral medications with a similar mechanism of action:
- Oral anti-androgens used in acne treatment are often contraceptive pills (to reduce androgen secretion) or the diuretic spironolactone (to inhibit androgen receptors). While effective for acne resistant to oral antibiotics, these medications are not prescribed for men due to side effects such as feminization and reproductive issues.
- In addition to being contraindicated in pregnant women, many women are reluctant to use systemic hormonal drugs due to concerns about fertility or menstrual cycle disruptions.
- In contrast, clascoterone is metabolized into cortexolone when applied to the skin. With small application areas, Winlevi only inhibits androgens locally and has not shown systemic effects. As such, clascoterone is recommended for use in both genders.
The most common local skin reactions include mild redness, itching, burning, or peeling. If these side effects occur, consult a doctor to adjust the frequency of application or explore alternatives.
Potential Risks:
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur during or after treatment with Winlevi. Conditions that increase systemic absorption include application over large surface areas, prolonged use, and the use of occlusive dressings.
- Pediatric patients may be more susceptible to systemic toxicity, which is why the medication is only recommended for children aged 12 and older.
- Elevated potassium levels (hyperkalemia) were observed in some subjects during clinical trials.
Current clinical trials primarily focus on the efficacy and side effects of Winlevi over 12 weeks. There is no long-term data yet, making this medication promising but requiring further study to better understand its benefits, side effects, and optimal combination with other drugs. Therefore, if you experience any unusual symptoms while using Winlevi, report them to your doctor for appropriate guidance.
Contact Information
- Contact us for a free consultation and appointment!
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WeDo Skin Clinic
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