INTEGUMENT-PED trial shows consistent efficacy of roflumilast cream in children aged 2 to 5

Managing atopic dermatitis (AD) in young children requires balancing efficacy, safety, and long-term tolerability—particularly given the challenges of immature skin barriers, widespread disease involvement, and caregiver concerns around topical corticosteroid use. INTEGUMENT-PED evaluated roflumilast cream 0.05% in children aged 2 to 5 years with mild-to-moderate AD, offering new insights into efficacy across diverse patient subgroups, early itch relief, and treatment tolerability.¹ In this Q&A, Vimal H. Prajapati, MD, of the University of Calgary, Dermatology Research Institute, and Skin Health & Wellness Centre, discusses how these findings may inform earlier treatment decisions, support confidence in treating children with skin of color, and clarify where roflumilast cream 0.05% may fit within evolving pediatric AD treatment algorithms.

Contemporary Pediatrics: In children aged 2 to 5 years with mild-to-moderate atopic dermatitis, what specific patient profiles from INTEGUMENT-PED might prompt you to consider roflumilast cream 0.05% as an early treatment option rather than reserving it for later lines of therapy?

Vimal H. Prajapati, MD: ZORYVE (roflumilast) cream 0.05% was intentionally formulated with atopic dermatitis in mind, and it is suitable for children with compromised skin barriers. In fact, the 0.05% dose was specifically selected for children aged 2-5 years based on the understanding of the skin barrier dysfunction associated with atopic dermatitis, which is especially important for young children because their skin is still maturing.

Additionally, children can have a more widespread presentation of atopic dermatitis, and thus, there is a greater body surface area to body mass ratio when considering their small stature.

ZORYVE cream 0.05% is a great option because it is safe and well-tolerated, and does not contain ingredients that may disrupt the integrity of the skin barrier, which is even more important for the skin of younger children with atopic dermatitis. ZORYVE cream 0.05% does not include known sensitizers, allergens, irritants, or penetration enhancers. And ZORYVE cream 0.05% is a water-based cream with moisturizing properties and is pH-balanced to the skin.

Topical corticosteroids are commonly used to treat atopic dermatitis, despite limitations such as increased risk of cutaneous and systemic side effects. Topical corticosteroids are not approved for long-term use, and higher potency options are not recommended for thin-skinned areas and specifically in children who have a greater body surface area to weight ratio and thus, greater systemic absorption.

Contemporary Pediatrics: The subgroup analysis showed consistent efficacy across race, ethnicity, and Fitzpatrick Skin Types. How should these findings influence clinicians’ confidence when treating children with skin of color, particularly given known differences in AD presentation and assessment challenges?

Prajapati: The subgroup analyses from INTEGUMENT-PED showed consistent treatment effects across race, ethnicity, and Fitzpatrick Skin Types, which can help reinforce clinician confidence that ZORYVE cream 0.05% performs similarly across diverse pediatric populations studied. Importantly, the results suggest that clinicians can consider ZORYVE cream 0.05% as a treatment option for young children with atopic dermatitis regardless of skin type, while continuing to use a comprehensive clinical assessment when evaluating disease severity and response.

Contemporary Pediatrics: From a practical standpoint, how meaningful were the improvements in itch observed by week 4, and how might this level of WI-NRS improvement affect caregiver satisfaction, sleep disruption, and overall disease burden in this age group?

Prajapati: Atopic dermatitis presenting in young children can impact the entire family by significantly disrupting sleep and can lead to emotional strain for both the child and caregivers. In fact, up to 87% of children with atopic dermatitis between the ages of 2 and 10 years experience sleep disruptions.

ZORYVE cream 0.05% provides rapid and effective relief of atopic dermatitis anywhere on the body, including signs and symptoms like itching, one of the most burdensome symptoms of this disease.

In the INTEGUMENT-PED trial, more than one-third (35%) of the 347 children using ZORYVE cream 0.05% had itch reduction within 4 weeks compared to just 18% of the 160 children using inactive cream. Results were consistent across a diverse range of skin types in subgroups defined by race, ethnicity, and Fitzpatrick Skin Types.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for atopic dermatitis were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.

Contemporary Pediatrics: Topical therapy tolerability is often a deciding factor in pediatric prescribing. Based on the safety and application-site findings, how would you counsel clinicians and caregivers about expected local reactions and what to monitor after treatment initiation?

Prajapati: ZORYVE cream 0.05% is safe and well-tolerated and does not contain ingredients that may disrupt the integrity of the skin barrier, which is even more important for the skin of younger children with atopic dermatitis. ZORYVE cream 0.05% does not include known sensitizers, allergens, irritants, or penetration enhancers. And ZORYVE cream 0.05% is a water-based cream with moisturizing properties, and is pH-balanced to the skin.

I counsel the caregivers of my patients that the most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for atopic dermatitis were upper respiratory tract infection, diarrhea, vomiting, rhinitis, conjunctivitis, and headache.

Contemporary Pediatrics: Given its nonsteroidal mechanism and once-daily dosing, where do you see roflumilast cream 0.05% fitting into treatment algorithms for young children with AD—particularly for long-term disease control or in patients where topical corticosteroid exposure is a concern?

Prajapati: ZORYVE cream 0.05% addresses a critical unmet need for young children with atopic dermatitis and offers a potential alternative to mid-to-high potency topical corticosteroids with a favorable safety profile. It offers healthcare providers, caregivers, and parents of children aged 2-5 years a long-term treatment option for this chronic condition with no limits on body surface area or duration of use.

Importantly, the simplicity of ZORYVE cream 0.05% with its once-daily application and suitability for use on all body areas can help reduce treatment burden for parents and caregivers, supporting consistent use and long-term disease control in this chronic condition.

Topical corticosteroids are commonly used to treat atopic dermatitis, despite limitations such as increased risk of cutaneous and systemic side effects. Topical corticosteroids are not approved for long-term use, and higher potency options are not recommended for thin-skinned areas and specifically in children who have a greater body surface area to weight ratio and thus, greater systemic absorption.

Reference:

Prajapati VH, Eichenfield LF, Browning JC. Once-daily Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Patients Aged 2–5 Years With Diverse Skin Types: Subgroup Analysis From the phase 3 INTEGUMENT-PED Trial. Poster. Presented at: 2026 Winter Clinical in Hawaii.