Winlevi® Q&A

WHAT IS WINLEVI®?

Winlevi® (clascoterone) is a a medical-breakthrough in the treatment of acne, because it focuses on androgen-sensitive sebum overproduction. The first time in 40 years, there is a new medication that treats acne differently.   Acne is not just for teenagers. Most everyone at some time in their life gets acne.  Although diet, stress, oily skin or hair or skin products may make acne worse, they are NOT the primary cause. Most often acne is due to sebum overproduction caused by androgens in your skin.  As a result of sebum overproduction, secondary bacterial infections and inflammation exacerbate the acne.  In contrast to most other acne treatments, which focus on the secondary infections and inflammatory response, Winlevi® is a first-of-its-kind androgen-receptor blocker that treats the secum overproduction.  The exact mechanism of how it works is unknown.

WHAT IS ACNE?

Acne is a disorder of the skin’s oil glands (sebaceous glands) located at the base of the hair follicle. Outbreaks of varying degrees of acne lesions, commonly referred to as pimples and zits, are due to plugged pores. Acne lesions occur most commonly on areas that have the highest concentration of sebaceous glands: face, neck, upper back, chest and shoulders.

When these oil glands become overactive and plug up the primary lesion of acne, comedones, commonly referred to as a blackheads (open comedones) or whiteheads (closed comedones) develop. Comedones are non inflammatory lesions characteristic of Grade I acne. The classic “pimple” develops as the bacteria (Propionibacterium acnes) beneath the skin thrive on this oil and produce redness and pus, Grade II – Grade III. As this infection spreads into the deeper layers of the skin pustules and cysts can develop, Grade IV. Although acne is not a serious health threat, if not treated acne can cause permanent scarring.

Winlevi® is a recommended topical treatment of Grade I – Grade III acne Vulgaris. Winlevi® is not indicated for those with Grade IV Acne where pustules and cysts predominate – severe pustular and deep cystic nodular acne known as Acne Conglobulata.

 

WHAT ARE THE DIFFERENT GRADES OF ACNE?

Acne varies in severity from some whiteheads and blackheads (Grade I) to severe pustular and cystic acne (Grade IV). Winlevi® is a recommended topical treatment of Grade I – Grade III acne vulgaris. Winlevi® is not indicated for those with Grade IV Acne where pustules and cysts predominate – severe pustular and deep cystic nodular acne is known as Acne Conglobulata.

 

ACNE- GRADE I: Comedones (whiteheads & blackheads) only 

Grade I Acne is characterized by open comedones and closed comedones commonly referred to as blackheads (open comedones) and whiteheads (closed comedones). There are no inflammatory lesions, making scarring unlikely.

ACNE GRADE II:  Comedones, papules and a few pastules

GRADE II Acne is characterized by mainly open and closed comedones (blackheads and whiteheads) and papules, with some pustules. Papules  are the classic “pimple” that develops when bacteria beneath the skin produces redness and pus.  These papules are small, granular lesions associated with the destruction of the epithelial lining of the sebaceous hair follicle wall. These may be inflammatory and scarring generally does not result.

ACNE- GRADE III: Comedones, papules, pustules, few nodules

 

Grade III acne is characterized by papules and pustules. Pustules have a yellowish, blister-like appearance and result from the breakdown of the follicle wall. Nodules are small, solid nodes detectable by touch. Scarring may be likely.

 

ACNE- GRADE IV:

GRADE IV: acne is characterized by a few comedones, some papules, and many pustules, nodules, cysts, and abscesses. This is a severe but not very common form of acne known as acne conglobata. Scarring exists and is generally severe. Winlevi® is NOT prescribed for this condition as you need direct dermatologist supervision. You need to consult your doctor or dermatologist.

WHO IS SUSCEPTIBLE TO ACNE?  ADULTS & TEENAGERS!

Acne is the most common skin disease affecting over 70 million people worldwide, over 17 million in the United States. Acne is not just an adolescent condition. Acne usually begins around puberty due to an increase in hormonal levels and usually tends to resolve within 10 years, but there is an increasing number of people, mostly women, who are being troubled by acne later in life. Acne affects nearly 85% of all adolescents and teens are troubled with acne. Nearly 5 million American adults suffer from acne and women are twice as likely as men to develop adult acne. In women, an increase in hormones prior to their menstrual cycle tends to make acne worse.

 

WHY DO I NEED TO TREAT ACNE?

Although acne is not a serious life threatening condition, if not treated acne can cause permanent scarring.  Grade III and IV Acne with deep pustules and cysts result in scarring.

 

WHO QUALIFIES FOR AN ONLINE WINLEVI® CONSULTATION?

If you are 18 years or older, not pregnant or breast feeding, and have been diagnosed by a physician with acne vulgaris – Grade I, II or III your are eligible for an online Winlevi® physician consultation. Winlevi® is NOT indicated for Grade IV. If you have Grade IV acne you need to see your physician or dermatologist.

 

HOW DOES WINLEVI® WORK TO TREAT ACNE?

Winlevi® (clascoterone) 1% cream is applied directly to the face or the affected area twice a day.  Although the exact mechanism of how it works is unknown, Winlevi® and an androgen-receptor blocker that attacks the sebum overproduction that is primarly the common cause of acne.  This sebum overproduction results in seconday bacterial infections and inflammation which other acne treatments target. Winlevi® is effective at clearing up pimples, whiteheads and blackheads and reducing pus-filled pimples.

• Inhibits effects of androgen hormones on cells in sebaceous glands
• Significantly reduces inflammatory and noninflammatory lesions

WHEN & FOR HOW OFTEN DO I USE WINLEVI®?

Winlevi® is applied to the skin twice daily, in the morning and evening.  Winlevi® must be used consistently as there is no instant or immediate cure for acne.
Step 1:  Wash the affected area with a mild nonsoap cleanser
Step 2:  Pat dry with a soft towel to remove excess water.  Never rub harshly.
Step 3:  Apply a pea-size amount of cream to affected area 2 times each day.. Spread a thin film evenly over the entire face, avoiding the eyes, lips, angles of the nose, and mucous membranes. Try not to touch the treated areas.
Step 4: Wash your hands

With proper care and treatment, acne can be controlled and scarring may be prevented. Use Winlevi® exactly as prescribed. Applying excessive amounts or using the formulation more than twice a day will not produce better results and may cause severe redness, peeling and discomfort.

HOW LONG BEFORE I SEE RESULTS?

Winlevi® acne treatment takes time to work.  You have to use it consistently as directed. In Winlevi® clinical trials, some people saw significant results in 12 weeks: clear or almost clear skin, and a significant reduction in whiteheads and blackheads.  If your does not show any improvement within 12 weeks, check with your own doctor.

HOW DOES WINLEVI® DIFFER FROM OTHER ACNE PRESCRIPTION TREATMENTS?

Winlevi® is the first-of-its-kind topical treatment that targets the root cause of most acne, sebum overproduction. In contrast, most other acne treatments target the secondary bacterial infections and inflammatory response.  Winlevi® is safe and is approved in both men and women over the age of 12 (we only prescribe for adults over the age of 18 online virtual consult).  Only pregnant and women who are breast feeding should not use Winlevi®.  In addition, people with Addison’s disease should be cautious need direct physician supervision.

WHAT FACTORS PLAY A PREDISPOSING OR EXACERBATING ROLE IN ACNE?

Heredity plays a very important role. Acne is a hereditary disease. Most people with acne know someone in the family that also had it at sometime. If both parents had severe acne, you too will have significant acne. If nobody in your family has bad acne, chances are you will not get severe acne. The acne skin that has overactive sebaceous glands with increased cellular and oil production is inherited and these are the precise factors that Winlevi® work against and controls.

Hormones play a role and during adolescence those prone to acne will begin to break out. Usually the acne outbreaks subside within 10 years but may continue on into adulthood. Women are especially prone to outbreaks during the hormonal changes during their menstrual  cycle. It is the male hormone in both males and females that is the cause the sebaceous oil gland to become overactive and result in acne outbreaks.

Stress:  During stressful times such as school exams, deadlines etc the male hormone in both males and females rise resulting in increased acne flare-ups.

Bacteria:  The bacterium, Propionibacterium acnes, which grows beneath the skin thrives on the oil in the sebaceous gland and plays an important role in the changes of noninflammatory acne to inflammatory acne.

 

DO DIET or BAD HABITS CAUSE ACNE OUTBREAKS?  MYTH or FACT?

From the beginning of time poor diet and a number of bad habits have been blamed as the leading causes for acne outbreaks. But the truth is that they have little or nothing to do with it. And while proper nutrition, exercise and plenty of sleep are great for general health, they do not have anything to do with preventing or curing acne.

Myth: People who don’t wash enough get acne. If your skin is clean it won’t break out.

FACT:  This is not true. Over-washing may actually irritate you skin.  The blackheads are  pores clogged with oil and an accumulation of skin cells within the pore, not dirt. Bacteria that reside under the skin (not on the surface of the skin) in the pores cause the inflammation of the hair follicles that contribute to the formation of pimples.

Myth: What you eat plays a big part in how your skin looks. For example, chocolate and greasy, fired “fast foods” cause your skin to break out or make your complexion worse.

FACT:  Food is neither the cause nor the cure for acne, yet many acne sufferers have followed difficult diets for years. For the most part, the food that you eat has little to do with acne outbreaks. The notion that chocolate or greasy, fried fast foods lead to greasy skin is incorrect. The oils you ingest has nothing to do with oil manufactured in your skin by the sebaceous gland. Although chocolate and greasy foods causing acne is a myth, it is possible for an individual to have a unique sensitivity to a certain food. If you believe a particular food causes your acne to flare up, avoid it for at least 60 days and see if your acne improves.

 

CAN WINLEVI® BE USED ALONG WITH OTHER SKIN MEDICATIONS OR PRODUCTS?

• Winelvi® should not be used on skin that has cuts, abrasions, eczema or sunburn.
• Winelvi® can be used as an adjuctive treatment with other topical or system acne treatments.
• Winelvi® should not be used with any abrasive or medicated soaps, astringents, alcohol, lime, or witch-hazel products, or any products than can be drying or irritating to the skin.
• Winelvi®should not be used with any peeling agents, glycolic peels, chemical peels or laser peels.
• Winelvi® should not be used with benzoyl peroxide, Skinoren or Azelex as they may be drying or irritating.
• Winelvi® can be used with topical anti-acne antibiotic treatments such as erythromycin, clindamycin, Dalacin-T or Cleocin-T. Do not use at the exact time and make sure completly absorbed and dried. Always check with your prescribing doctor before adding Winelvi®.
• Winelvi® can be used with non-oily noncomedogenic moisturizers and cosmetics.

 

WHAT KIND OF CLEANSER SHOULD I USE WHILE USING WINLEVI®?

Acne is not caused by dirt, and too much vigorous washing can dry your skin or even aggravate your acne. Cleansing twice a day is sufficient with a mild, NONSOAP, fragrance-free cleanser such as Cetaphil® Cleansing Bars or Cetaphil® Gentle Skin Cleansers. Do not use medicated soaps and cleansers that have a strong drying affect.

 

CAN I WEAR MAKEUP WHILE USING WINLEVI®?

Yes, you can wear makeup. Do NOT use oil-based makeup or cosmetics that have an abrasive, drying or peeling action. Make sure than when you buy cosmetics, moisturizers or any other skin products they are labeled as “noncomedogenic” or “nonacnegenic.” This means that they are not likely to cause whiteheads or blackheads.

 

WHILE USING WINLEVI® SHOULD I USE A MOISTURIZER?

Use a mild, fragrance-free, non-oily, non-irritating moisturizer that is noncomedogenic. Make sure your moisturizer does NOT contain any other drying or irritating agent. Cetaphil® Moisturizers are a possible choice.

WHAT ARE THE SIDE EFFECTS of WINLEVI®?

Winlevi® is FDA-approved and safe and effective.

• Side effects were generally mild to moderate.
• The most common reactions, exeprienced by 7 to 12% of patients,were mild skin redness, scaling or dryness, and itching where WINLEVI was applied.
  
• Less than 2% of patients experienced systemic side effects: symptoms of a disorder where the adrenal gland does not make enough of certain hormones. Your doctor may stop your treatment if this occurs.
• WINLEVI was proven safe in patients who used the treatment for up to 12 months.

If severe irritation occurs, blistering, crusting or swelling discontinue use and check with your physician.

These are not all of the possible side effects of WINLEVI.

WHO SHOULD NOT USE WINLEVI®?

• Do NOT use Winlevi® if you are pregnant or attempting to become pregnant.Winlevi® MAY HARM an unborn baby.
• Do NOT use Winlevi® if you are breast feeding.
• Do NOT use Winlevi® if have Addison’s disease or adrenal insufficiency
• Winlevi® is NOT to be used in children or anyone under the age of 18. Not approved for pediatric use below age 12 but we do not prescribe for anyone less than 18 year of age online.

 

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