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WINLEVI® (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

WINLEVI and dr. sandra lee, aka dr. pimple popper

WINLEVI is proud to partner with Dr. Lee, one of the world’s foremost authorities on skin care, dermatology, and acne. She brings her 25 years of dermatology and cosmetic surgery experience to help answer questions about how WINLEVI works, why you get acne in the first place, and when it’s time to talk to your dermatology professional.

Watch Dr. Lee explain how WINLEVI is different

ACNE CAN AFFECT ANYONE

Due in part to increased hormone activity in the skin

Not actual patients.

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Face covered in acne

If you have hormonal acne breakouts, you already know that hormone changes are linked to acne breakouts, such as on the chin and jawline. But what you might not know is that ALL acne is related to acne hormones.

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Hormone levels change throughout our lifetime, for both FEMALES and MALES, in every age and stage of life.

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Certain hormones in the skin, called androgens, may ultimately lead to acne.

Focus on the underlying

CAUSE OF ACNE

HormoneS FLUCTUATE

Sebum increases

Bacteria grows

ACNE BREAKS OUT

This stimulates the sebaceous glands in the skin to make sebum, an oily wax.

Excess sebum acts as food for acne-causing bacteria.

Bacterial growth may lead to inflammation.

The chain reaction can cause acne to appear.

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What do you know about acne hormones?

Which is caused by acne hormones in the skin?

At what age can people have acne caused by acne hormones?

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(clascoterone) cream 1%

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Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly if you:

  • have skin problems, including eczema, cuts or sunburn.
  • are pregnant or plan to become pregnant. It is not known if WINLEVI cream will harm your unborn baby

Important Safety Information

Indication

What is WINLEVI® cream?

WINLEVI (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

It is not known if WINLEVI cream is safe and effective in children under 12 years of age.

Important Patient Information

Before using WINLEVI cream, tell your healthcare provider about all of your medical conditions, particularly if you:

  • have skin problems, including eczema, cuts or sunburn
  • are pregnant or plan to become pregnant. It is not known if WINLEVI cream will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if WINLEVI cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with WINLEVI cream

WINLEVI cream is for use on the skin only (topical). Do not use WINLEVI cream in or on your eyes, mouth, or vagina. Do not use WINLEVI cream for a condition for which it was not prescribed. Do not give WINLEVI cream to other people, even if they have the same symptoms you have. It may harm them.

What are the possible side effects of WINLEVI cream?

WINLEVI cream can cause serious side effects, including:

  • local skin reactions. WINLEVI cream may cause local skin irritation including itching, burning, skin redness or peeling.
  • symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment with WINLEVI. Your healthcare provider may stop your treatment with WINLEVI if you develop any adrenal problems.

The most common side effects of WINLEVI cream include reddening, scaling or dryness, and itching of the skin being treated.
These are not all of the possible side effects of WINLEVI cream.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555.

Please see full Prescribing Information and the Patient Information.