FAQ – Zoryve (roflumilast foam, 0.3%)

What is Zoryve?

Seborrheic dermatitis most often occurs in hair-bearing areas of the body (e.g., scalp, face, chest, back, and groin) with symptoms such as scaling, erythema, and itching.  It’s important to talk to your doctor about how seborrheic dermatitis affects not just your skin but also other aspects of your life. 

Zoryve (roflumilast foam, 0.3%) is a topical foam approved by the FDA for the treatment of seborrheic dermatitis in adults and children ages 9 and older.

Together, you and your healthcare provider can determine if Roflumilast foam, 0.3%  is an appropriate treatment option.  

How does Zoryve work?

Zoryve foam is not a topical steroid.  Zoryve inhibits the enzyme phosphodiesterase-4 (PDE4), which is involved in the production of pro-inflammatory mediators. This action reduces inflammation in dermatological conditions.

How do you use Zoryve foam?

Zoryve is applied as a thin film once daily to the affected areas of skin when they are not wet. 

How effective is Zoryve foam for seborrheic dermatitis? 

In the Phase 2 (Trial 203) and STRATUM Phase 3 clinical trials for Zoryve foam, after 8 weeks of continuous use1:

  • 79.5% (STRATUM) and 73.1% (Trial 203) of individuals treated with Zoryve foam achieved the primary endpoint Investigator Global Assessment (IGA) of 0-1 (clear or almost clear) with at least a 2-grade improvement from the start of the trial compared to 58% (Trial 203) and 40.8% (STRATUM) of those not treated with Zoryve foam.  
  • In the STRATUM trial, 50.6% of individuals treated with Zoryve reached complete clearance (IGA=0) at Week 8. 
  • Investigator Global Assessment (IGA) is a 5-point scale that provides a global clinical assessment of atopic dermatitis by the investigator, based on signs and symptoms.  

Secondary endpoints in these trials after 8 weeks of continuous use of Zoryve foam included itch, scaling, and erythema (redness)1:

  • More than 60% of individuals achieved a ≥4-point reduction in itch at Week 8 (62.8% with Zoryve vs 40.6% vehicle).
  • More than 50% of individuals treated with Zoryve achieved an erythema score of 0 at week 8.
  • More than 50% of individuals treated with Zoryve achieved a scaling score of 0 at week 8. 

What are the side effects of Zoryve foam?

In clinical trials, the most common side effects in Phase 2 and 3 clinical trials (over 1%) were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).1

The full prescribing information for Zoryve foam can be found here

How is Zoryve foam different from topical corticosteroids (TCS)?

Topical corticosteroids work to reduce inflammation in the skin by preventing cells from producing inflammation-causing chemicals that are released in response to a variety of different triggers. Zoryve foam reduces inflammation by more specifically inhibiting a specific enzyme called PDE4 that contributes to skin inflammation.  And because Zoryve foam is not a TCS, it is able to be used over a longer period of time and anywhere on the body, including areas where TCS use is not preferred. 

How long do I have to use Zoryve foam?

In clinical trials, the duration of use for Zoryve foam was 8 weeks, and further studied out to 52 weeks.1

Together, you and your healthcare provider can determine what is the most appropriate treatment approach with Zoryve foam, including overall duration of use.

Can children use Zoryve foam?

Yes. Zoryve foam is FDA-approved for children ages 9 years and older. 

How much does Zoryve foam cost?

Cost depends on your health insurance coverage for prescriptions. Arcutis, the company that makes Zoryve, has programs to help with your copay costs if needed. You can find more information at Arcutis Cares or call 855-600-3755, Monday through Friday, from 8 a.m. to 8 p.m. ET.

How do I know if Zoryve foam is right for me?

It’s important to talk to your doctor about how seborrheic dermatitis affects your skin and other aspects of your life.  Together, you and your healthcare provider can determine if Zoryve foam is an appropriate treatment option.  

How can I get Zoryve foam?

Roflumilast foam is available by prescription only. Talk to your health care provider and visit https://www.zoryve.com/ to learn more.

Can I use Zoryve foam with other prescription seborrheic dermatitis therapies?

Talk to your health care provider about using Zoryve foam with other prescriptions and over the counter therapies for seborrheic dermatitis. Be sure your doctor knows all medications you are using for your seborrheic dermatitis as well as other medical conditions.  

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  1. FDA Approves Arcutis’ Zoryve (roflumilast) Topical Foam, 0.3% for the treatment of seborrheic dermatitis in individuals aged 9 years and older. https://www.arcutis.com/zoryve-foam-appr ↩︎

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