Roflumilast Cream 0.15% Receives Strong Recommendation for Atopic Dermatitis in AAD Guideline Update

Roflumilast cream 0.15% (ZORYVE) has received a strong recommendation in the American Academy of Dermatology’s (AAD) focused guideline update for the management of mild to moderate atopic dermatitis (AD) in adults, according to a June 26 announcement from Arcutis Biotherapeutics.¹ Among newly evaluated branded topical therapies, roflumilast 0.15% is the only agent to receive a strong recommendation, the company noted, reflecting its demonstrated ability to reduce pruritus and disease severity while maintaining a favorable safety and tolerability profile.¹

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The nonsteroidal, topical phosphodiesterase-4 (PDE4) inhibitor is indicated for use in adults and children aged 6 years and older, offering clinicians a targeted treatment option suitable for sensitive and difficult-to-treat areas of the body.¹

The AAD’s focused update integrates newly FDA-approved topical and biologic therapies into existing guidelines to ensure clinicians have access to the most current, evidence-based recommendations for this chronic inflammatory condition.² Roflumilast cream 0.15% joins tapinarof cream, lebrikizumab, and nemolizumab (with concomitant topical therapy) as 1 of 4 new agents included in the latest guidance.²

“The AAD’s focused update highlights therapies that meet rigorous standards for efficacy, safety, and tolerability for adults living with AD,” Patrick Burnett, MD, PhD, chief medical officer at Arcutis, said in the statement. “The inclusion of [roflumilast 0.15%] in these recommendations validates what healthcare professionals have already experienced with [the therapy] in their practice – a next-generation, steroid-free topical that delivers meaningful improvement for people with AD.”¹

Roflumilast is the only FDA-approved branded topical PDE4 inhibitor indicated for AD, plaque psoriasis, and seborrheic dermatitis. The strong recommendation in adult AD underscores its relevance in current dermatologic care.¹ “The AAD’s strong recommendation helps guide clinicians and patients toward treatments that deliver clinically meaningful improvements in disease severity while being safe and well tolerated for long-term use,” Arcutis noted in the announcement.¹ [Roflumilast 0.15%] was also recently awarded the National Psoriasis Foundation’s Seal of Recognition, the first FDA-approved prescription product to earn the honor.³

Efforts to expand the approved use of [roflumilast 0.15%] in pediatric populations are ongoing. The FDA is currently reviewing a supplemental New Drug Application for the use of roflumilast cream 0.05% in children aged 2 to 5 years with mild to moderate AD.⁴ The application is supported by pivotal phase 3 trials (INTEGUMENT-PED), long-term extension data (INTEGUMENT-OLE), and pharmacokinetic studies. A Prescription Drug User Fee Act target action date is set for October 13, 2025.⁴

Burnett noted the particular treatment challenges in younger populations in an earlier statement⁵: “AD presents unique challenges in this youngest age group, not only because the skin is more sensitive, but also because the condition often covers a greater percentage of their total body surface area compared to older children and adults. In addition, long-term management of AD requires treatment that can deliver rapid relief of itch, sustained symptom improvement over time, and that is tolerable when applied to the skin.” He added, “Our goal is to address this unmet need by providing advanced targeted topical therapies that can manage symptoms effectively over the long-term, while also improving the quality of life for individuals and their families living with this chronic condition.”⁵

Additionally, the phase 2 INTEGUMENT-INFANT study will evaluate the safety and efficacy of roflumilast in infants aged 3 months to under 2 years.⁶

Atopic dermatitis affects an estimated 16.5 million adults in the US and remains the most common form of eczema. The AAD’s updated recommendations help ensure that treatment decisions reflect the latest safety and efficacy data from real-world use and clinical trials, enabling dermatologists to tailor care to patients' evolving needs.¹

References

1. Arcutis’ ZORYVE® (roflumilast) cream 0.15% receives strong recommendation in American Academy of Dermatology updated guidelines for adult atopic dermatitis. News release. Arcutis Biotherapeutics. June 26, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/26/3105808/0/en/Arcutis-ZORYVE-roflumilast-Cream-0-15-Receives-Strong-Recommendation-in-American-Academy-of-Dermatology-Updated-Guidelines-for-Adult-Atopic-Dermatitis.html

2. Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. Published online June 17, 2025. doi:10.1016/j.jaad.2025.05.1386

3. NPF expands seal of recognition to FDA-approved treatments and awards its first to Arcutis’ Zoryve (roflumilast). News release. Arcutis Biotherapeutics. June 2, 2025. Accessed June 26, 2025. https://www.arcutis.com/npf-expands-seal-of-recognition-to-fda-approved-treatments-and-awards-its-first-to-arcutis-zoryve-roflumilast/

4. U.S. FDA accepts supplemental new drug application for Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. News release. Arcutis Biotherapeutics. February 26, 2025. Accessed June 26, 2025. https://investors.arcutis.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-arcutis-zoryver

5. Arcutis to present new long-term results of ZORYVE® (roflumilast) cream at the 2025 Revolutionizing Atopic Dermatitis Conference. News release. Arcutis Biotherapeutics. June 6, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/06/3095048/0/en/Arcutis-to-Present-New-Long-Term-Results-of-ZORYVE-roflumilast-Cream-at-the-2025-Revolutionizing-Atopic-Dermatitis-Conference.html

6. Hebert A, Eichenfield L, Gonzalez M, et al. INTEGUMENT-INFANT: a phase 2, 4-week, open-label safety study of roflumilast cream 0.05% in infants aged 3 months to less than 2 years with atopic dermatitis. Poster presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, Tennessee.