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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

The

Teenage

Years

just one of the many ages and stages that struggle with hormone-driven acne.

Not actual patients.

Man kissing son's head

Throughout our lifetime, hormone levels are always changing—for both females AND males.

An excess of certain hormones in the skin, called androgens, can help contribute to the development of acne. People with acne may produce more androgen hormones, increasing the amount of sebum and inflammation, which may lead to acne.

Tube of Winlevi

WINLEVI is the first and only prescription cream that targets acne-causing hormones in the skin.

WINLEVI is the only topical that treats acne by preventing acne hormones (androgens) from reaching their target—the sebaceous glands. Fewer androgens in your teen’s skin may mean reduced sebum and potential bacterial growth and inflammation. And that means an improvement in acne in ALL acne patients 12 and older.

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.

The exact way WINLEVI works on acne is unknown.

WINLEVI is FDA-approved

The safety of WINLEVI was studied over 12 months.

  • WINLEVI demonstrated safety in both FEMALE and MALE patients who used the treatment for up to 12 months.

  • Side effects were generally mild to moderate.

  • The most common reactions were mild skin redness, peeling or dryness, and itching where WINLEVI was applied. These are not all of the possible side effects of WINLEVI.

  • In a study where people applied 6X the prescribed amount of WINLEVI, some patients experienced a disorder where the adrenal gland does not make enough of certain hormones. However, this did not occur in WINLEVI clinical trials with the prescribed twice-daily dosing of one gram.

  • Learn more about the safety profile of WINLEVI.

In clinical studies, WINLEVI showed improvement in acne at 12 weeks of use

Reduced pimples, whiteheads, and blackheads

Clear or almost clear skin

A noticeable reduction in acne was seen as early as week 4

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.

SEE THE
REAL
RESULTS
With
winlevi

MALE WINLEVI PATIENT

Male face before using Winlevi
Male face at 12 Weeks of using Winlevi

FEMALE WINLEVI PATIENT

Female face before using Winlevi
Female face at 12 Weeks of using Winlevi

MALE WINLEVI PATIENT

Male face before using Winlevi
Male face at 12 Weeks of using Winlevi

FEMALE WINLEVI PATIENT

Female face before using Winlevi
Female face at 12 Weeks of using Winlevi

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.

Doesn’t INCREASED sebum contribute to acne?

YES, but…

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.

See how WINLEVI fits into your teen’s skincare routine

Twice a day, every day.

Eligible patients can save on WINLEVI

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Winlevi Co-Pay Savings Card

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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.