Exploring a Long-Misunderstood Chronic Skin Disorder

Max’s story

For years, seborrheic dermatitis was widely thought to be driven mainly by yeast overgrowth, which is why antifungal treatments have often been used. But newer research is giving scientists a fuller picture of the condition, pointing to skin barrier problems, immune system imbalance, and inflammation as major factors. That growing understanding is helping researchers better address seborrheic dermatitis, which affects more than 10 million people in the US.

Those same factors appear to play a larger role than once believed. The condition is often identified by itching, flaking, or greasy patches in oily, hair-bearing areas such as the scalp, face, ears, and trunk.

Because the symptoms can show up in different places and in different ways, patients may struggle to know where to seek help. In a third-party survey of 300 patients sponsored by Arcutis Biotherapeutics, adults with moderate to severe seborrheic dermatitis said they used an average of six treatments a week, including prescription, over-the-counter, and alternative remedies, and spent more than 30 minutes a day dealing with their symptoms.

For most of his life, pro golfer Max Homa lived with seborrheic dermatitis without realizing what it was or finding a treatment that truly helped.

He spent years assuming the problem was dandruff and tried countless over-the-counter products for the itchy, uncomfortable patches on his face and scalp. Nothing seemed to work. As he appeared more often in front of crowds and cameras, he also found himself worrying before major events about whether the flaking would be noticeable.

“I was embarrassed about my red and flaky skin,” he says. “It seemed like such a small thing, but to me, it was a constant thought. ‘Is my skin flaking? Can people see it?’”

After seeing a dermatologist, he learned the issue was not simply dry skin. “Turns out, my symptoms are actually seborrheic dermatitis,” he says.

He was prescribed steroid-free ZORYVE^® (roflumilast) topical foam 0.3%, which has helped reduce the flakes, itching, and redness linked to his seborrheic dermatitis. Individual results may vary.

ZORYVE in Clinical Trials

ZORYVE was evaluated in two clinical trials involving 683 people with seborrheic dermatitis. In those studies, 458 people used ZORYVE foam and 225 used a vehicle foam without the active ingredient on affected areas for eight weeks.

Across the combined trials, 77% of people using ZORYVE once daily had Clear or Almost Clear skin at eight weeks, compared with 53% of those using vehicle.

In one of the trials, 63% of 206 people had significant itch relief at Week 8 with ZORYVE, versus 41% of 98 people using foam without the active ingredient.

Approved Use

ZORYVE foam is a prescription medicine applied to the skin to treat seborrheic dermatitis in adults and children 9 years of age and older.

It is not known whether ZORYVE foam is safe and effective in children under 9 years of age with seborrheic dermatitis.

IMPORTANT SAFETY INFORMATION

ZORYVE is for use on the skin only. Do not use ZORYVE in your eyes, mouth, or vagina. Do not use ZORYVE if you have certain liver problems.

See below for additional Important Safety Information, including the most common side effects.

The active ingredient in ZORYVE

ZORYVE contains roflumilast, a phosphodiesterase-4 (PDE4) inhibitor. When PDE4 becomes overactive, it can contribute to symptoms associated with seborrheic dermatitis.

As a PDE4 inhibitor, ZORYVE works to:

• Decrease inflammation in the skin
• Help balance the skin’s immune response

The exact way ZORYVE treats seborrheic dermatitis is not known.

The formulation of ZORYVE

The leave-in foam is designed for easy once-daily use on oily, hairy areas of the body.

• The lightweight formula spreads easily through hair.
• ZORYVE foam is a water-based vehicle free of common irritants and propylene glycol. In clinical studies, 1.3% of patients reported a hot, tingling, or stinging sensation after the first application.
• ZORYVE foam can be used once daily on all affected skin areas, including thin facial skin, for as long as needed.

Max's experience

“Once I started using ZORYVE foam for my seborrheic dermatitis, the redness and flaking subsided in a few weeks,” he recalls. “The skin around my nose that bothered me before has cleared up. And on my beard and scalp, the flakiness and itching have gotten noticeably better.”

With less flaking and redness, Homa says he no longer has to think about his skin as much. Individual results may vary.

Max is a real patient treated with ZORYVE who was paid for his time spent sharing his experience.

IMPORTANT SAFETY INFORMATION, continued

Before using ZORYVE, tell your healthcare provider about all of your medical conditions, including if you:
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if ZORYVE will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ZORYVE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ZORYVE. Breastfeeding women using ZORYVE should use it on the smallest area of the skin and for the shortest time needed. Do not apply ZORYVE directly to the nipple or areola to avoid contact with your baby. Avoid direct skin contact of treated areas with your baby if ZORYVE is applied to your chest.

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

What should I avoid while using ZORYVE?
ZORYVE foam is flammable. Avoid fire, flame, and smoking during and right after you apply ZORYVE.

The most common side effects of ZORYVE include:
• common cold
• nausea
• headache

These are not all of the possible side effects of ZORYVE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information and Instructions for Use for ZORYVE.

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