The common wisdom about seborrheic dermatitis, a chronic skin condition has focused on the role of yeast overgrowth— leading to many treatments being antifungals. But more and more research has led scientists to better understand seborrheic dermatitis and the roles of skin barrier dysfunction, immune dysregulation and inflammation. The evolving understanding is helping researchers learn more about seborrheic dermatitis, which affects more than 10 million people in the US.
Skin barrier dysfunction, immune dysregulation and inflammation were found to have bigger roles in seborrheic dermatitis than previously understood. It is often diagnosed because of hallmark symptoms such as itching, flaking, or greasy patches on oily, hair-bearing environments like the scalp, face (eyebrows, eyelids, nose, and beard), ears, and trunk.
Having so many symptoms can make it difficult for patients to understand how and where to find care. In a third-party 2022 survey of 300 patients sponsored by Arcutis Biotherapeutics, adults with moderate to severe seborrheic dermatitis reported that on average they use 6 treatments per week, including prescription, over-the-counter, and alternative treatments, and spend more than 30 minutes a day managing their seborrheic dermatitis symptoms.
Max’s story
For most of his life, pro golfer Max Homa has been dealing with seborrheic dermatitis—although for quite a long time he didn’t know what he was dealing with—let alone a treatment that could work for him.
Over the years, he mistakenly chalked his symptoms up to dandruff, trying countless over-the-counter products for the itchy, uncomfortable patches of flaking skin on his face and scalp. Nothing really worked for him. But as he began to be in front of a lot of people and cameras more often, he found himself waking up before big events like interviews or tournaments, worrying about the flakiness.
“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 visiting a dermatologist, he finally learned it wasn't just 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 his flakes, itching, and redness from seborrheic dermatitis. (Individual results may vary.)
ZORYVE in Clinical Trials
ZORYVE was studied in two clinical trials of 683 people with seborrheic dermatitis, in which 458 people used ZORYVE foam while another 225 people used vehicle (a foam not containing the active ingredient) on affected areas for 8 weeks.
In combined clinical trials, 77% of people using ZORYVE once daily had Clear or Almost Clear skin at eight weeks vs 53% of people using vehicle.
In one of the clinical trials, 63% of 206 people had significant itch relief at Week 8 with ZORYVE vs. 41% of 98 people using foam not containing the active ingredient.
Approved Use
ZORYVE foam is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in adults and children 9 years of age and older.
It is not known if ZORYVE foam is safe and effective in children with seborrheic dermatitis under 9 years of age.
IMPORTANT SAFETY INFORMATION
ZORYVE is for use on the skin (topical use) 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 most common side effects.
The active ingredient in ZORYVE
ZORYVE contains roflumilast, a phosphodiesterase-4 (PDE4) inhibitor. When PDE4 works too much, the results can be associated with the symptoms of seborrheic dermatitis.
ZORYVE works as a PDE4 inhibitor, a molecule that manages PDE4 activity, to:
- Decrease inflammation in the skin
- Balance the skin's immune system
The exact way ZORYVE works to treat seborrheic dermatitis is unknown.
The formulation of ZORYVE
The leave-in foam can navigate hairy and oily areas of the body with a convenient once-daily application.
- The lightweight formula of ZORYVE spreads easily through hair.
- ZORYVE foam is a water-based vehicle free of common irritants as well as 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 really hasn’t had 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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US-COM-154-00391 09/26
