Is Clascoterone approved by the FDA?

Yes, clascoterone (Winlevi) is an FDA-approved topical cream for the treatment of acne vulgaris in patients aged 12 and older. Approved on August 26, 2020, it offers a novel mechanism of action by inhibiting androgen receptors in the skin, reducing oil production and inflammation associated with acne.

What is Clascoterone?

Clascoterone is a topical medication used for the treatment of acne vulgaris in individuals aged 12 and older. It is part of the drug class of topical acne agents and is applied directly to the skin in the form of a 1% cream.

How Clascoterone Works

Clascoterone works by blocking the effects of androgens (male hormones) on the skin's sebaceous (oil) glands. Androgens can increase oil production and inflammation, leading to acne. By inhibiting these hormones, clascoterone helps reduce acne lesions.

Administration and Dosage

Clascoterone is intended for topical use only and should not be ingested. The typical dosage involves applying a thin, uniform layer of the cream to the affected areas twice a day, once in the morning and once in the evening. It is important to follow the prescribed instructions carefully:

• Wash your hands before and after applying the cream.
• Clean the affected area with mild soap and water, then dry thoroughly.
• Apply a small amount of the cream, rubbing it in gently.
• Do not cover the treated skin with a bandage unless instructed by your doctor.

Potential Side Effects

Clascoterone can cause a range of side effects, from common to serious:

Common Side Effects:

• Redness
• Itching
• Stinging or burning sensation
• Swelling of treated skin
• Dry or scaly skin

Serious Side Effects:

• Severe itching, burning, peeling, or redness
• High blood potassium levels (hyperkalemia)
• Decreased adrenal gland hormones

If you experience any serious side effects, you should contact your doctor immediately.

Warnings and Precautions

• Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding.
• Eczema or Skin Problems: Inform your doctor if you have a history of eczema or other skin conditions.
• Avoidance: Do not apply clascoterone to open wounds, eczema-affected areas, or sunburned skin. Avoid getting the cream in your eyes, mouth, nose, vagina, or rectum.

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