FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis in Children as Young as 2

The FDA has approved a supplemental new drug application expanding the indication for roflumilast (Zoryve; Arcutis Biotherapeutics) cream 0.3%, making it the first once-daily, steroid-free topical therapy approved for plaque psoriasis in children as young as 2 years.¹

The approval extends use of the topical phosphodiesterase type 4 (PDE4) inhibitor to children aged 2 to 5 years, including for use on intertriginous areas such as skin folds. This marks the seventh FDA approval for roflumilast in 4 years, reflecting the drug's expanding role across inflammatory dermatoses.¹

A Persistent Need in Pediatric Psoriasis Care

Plaque psoriasis affects nearly 9 million individuals in the United States, presenting with itch, scaling, redness, and flaking that can appear anywhere on the body, including thin-skinned areas like the face and genitals. In patients with darker skin tones, plaques may present as more grayish, purplish, or brown rather than the classic red appearance. According to Arcutis president and CEO Frank Watanabe, children with plaque psoriasis under age 6 have historically had few treatment options suitable for long-term use, leaving families and clinicians to manage a chronic, progressive condition with limited choices. The newly approved indication for roflumilast cream 0.3% is intended to directly address that gap.¹

Clinical Evidence Supporting the Expanded Indication

The pediatric approval was supported by an open-label study evaluating pharmacokinetics, safety, tolerability, and exploratory efficacy of roflumilast cream 0.3% in children with plaque psoriasis affecting at least 2% of body surface area, along with a long-term safety extension study, ARQ-151-306, assessing children aged 2 to 5 years over up to 24 weeks of treatment.¹

Investigators reported that safety and efficacy profiles in this younger population were generally consistent with those previously established in the pivotal DERMIS-1 and DERMIS-2 phase 3 trials. Those identical, double-blind, vehicle-controlled trials enrolled 439 and 442 participants, respectively, with patients aged 2 years and older with 2% to 20% body surface area involvement; roughly 40% of roflumilast-treated participants achieved a 75% reduction in Psoriasis Area and Severity Index (PASI-75) scores by week 8, compared with single-digit percentages in the vehicle arms (P < .001 for both trials). Roflumilast cream and vehicle demonstrated similar rates of treatment-related adverse events, with no serious adverse events reported in either trial.^1,2

Mechanism of Action and Place in Therapy

Roflumilast is a topical, targeted PDE4 inhibitor. By inhibiting PDE4, an intracellular enzyme implicated in inflammatory dermatologic disease, the cream reduces production of proinflammatory mediators, decreasing skin inflammation and helping rebalance the cutaneous immune response. Notably, the cream carries no restrictions on duration of use and is approved for application anywhere on the body, including sensitive intertriginous areas, distinguishing it from topical corticosteroids that typically carry such limitations.¹

Access and Pharmacist Counseling Considerations

Arcutis offers support for patients prescribed roflumilast through its Zoryve Direct Program, which assists with insurance navigation, adherence, and a savings card program for eligible commercially insured patients, alongside the Arcutis Cares patient assistance program for uninsured or underinsured individuals. Pharmacists counseling caregivers of young patients should emphasize the once-daily, steroid-free dosing regimen and the absence of duration-of-use restrictions, key differentiators from prior topical standards of care in this population.¹

Expert Insights

Lisa Swanson, MD, FAAD, a board-certified pediatric dermatologist and clinical trial investigator, discussed the significance of this milestone in an interview with Pharmacy Times.

Pharmacy Times: The approval is based on a relatively small, open-label pharmacokinetic/safety study in 2- to 5-year-olds rather than a randomized, placebo-controlled efficacy trial—how confident can we be in the drug's actual efficacy in this age group versus its safety/PK profile alone?

Lisa Swanson, MD, FAAD: As a prescriber, I feel confident in the safety and efficacy of roflumilast given that it was extensively studied in the DERMIS pivotal studies and long-term extension study, and real-world results have been consistent. It is important to understand that roflumilast cream 0.3% was first approved in September of 2022, and the age indication was expanded down to age 6 in October of 2023.

In clinical studies, roflumilast cream 0.3% demonstrated meaningful improvements in the signs and symptoms of plaque psoriasis and was safe and well tolerated in children as young as age 2. And overall, safety and efficacy profiles were generally consistent with those observed in the pivotal Phase 3 trials in adolescents and adults.

The most common adverse reactions reported (≥1%) for roflumilast cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

Pharmacy Times: Given that roflumilast has no restrictions on duration of use or body location, what is known about long-term systemic absorption and safety in very young children with a higher skin-surface-to-body-weight ratio beyond the 24-week extension study data?

Swanson: Maximal Usage Systemic Exposure (MUSE) studies such as the one conducted for roflumilast cream in children ages 2 to 5 years (ARQ-151-216) are specifically designed to assess the pharmacokinetics, safety, and tolerability of a drug. Combined with the 24-week open-label extension study and the extensive real-world experience since roflumilast cream was initially approved in September 2022, this provides a large body of clinical evidence to support its use.

Tolerability is also of great importance. Roflumilast cream 0.3% is formulated to be well tolerated in sensitive areas, which is particularly important for young children with plaque psoriasis who may have more involvement on the face and skin folds. Roflumilast is a water-based cream that does not include sensitizers, irritants, or penetration enhancers.

I feel confident prescribing roflumilast for my plaque psoriasis patients as young as 2 as a long-term treatment option from both a long-term safety and efficacy perspective.

Pharmacy Times: How does roflumilast cream 0.3% compare practically (efficacy, tolerability, ease of use, cost/access) to existing off-label treatments dermatologists have used for psoriasis in children under 6, such as low-potency topical steroids or other off-label agents?

Swanson: There are few safe and effective treatment options for young children with plaque psoriasis, which has left a large unmet need in this age group. Roflumilast cream 0.3% is the first once-daily, steroid-free therapy approved for children with plaque psoriasis as young as 2 years of age and can be used anywhere on the body for any duration of time. Presently, there are no head-to-head studies comparing roflumilast cream to other therapies. While topical corticosteroids are commonly used to treat pediatric plaque psoriasis, they are not recommended in sensitive areas such as the face or skin folds and cannot be used for the long term.

It’s important to have options, and patients and providers will appreciate that roflumilast cream is once-daily, steroid-free, and can be used anywhere on the body for as long as it is needed.

REFERENCES

1. FDA approves Arcutis' Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2. News release. Arcutis Biotherapeutics. June 29, 2026. Accessed June 30, 2026. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-children-as-young-as-age-2/

2. Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: The DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632