Phase 3 Data Indicate Roflumilast Cream Benefit Extend to Youngest Atopic Dermatitis Patients

A pair of poster presentations at the Revolutionizing Atopic Dermatitis (RAD) 2026 Conference offer insights into the effects of roflumilast cream (Zoryve) across the pediatric age spectrum of atopic dermatitis.

Leveraging data from INTEGUMENT-INFANT, an open-label safety and exploratory efficacy trial of roflumilast 0.05% cream in infants aged 3 to 24 months, and a phase 3 vehicle-controlled trial of roflumilast 0.15% cream in patients aged 6 years and older with mild-to-moderate atopic dermatitis, investigators demonstrate the consistency in benefit for even the youngest patients included.^1,2

INTEGUMENT-INFANT: safety-primary trial in infants 3-24 months

INTEGUMENT-INFANT enrolled 101 infants aged 3 to less than 24 months with mild-to-moderate atopic dermatitis and at least 3% body surface area involvement, most of whom had a prior inadequate response, intolerance, or contraindication to topical corticosteroids. Patients received roflumilast cream 0.05% once daily for 4 weeks and the primary endpoints were treatment-emergent adverse events and application-site tolerability.

Exploratory efficacy results included vIGA-AD treatment success, which is defined as score 0/1 with ≥2-point improvement, in 34.0% of patients at week 2 and 49.0% at Week 4. IGA-Scalp success was achieved in 58.3% at week 4. Additionally, EASI-75 was achieved in 67.5% at week 4.

On the Worst Scratch Intensity-NRS (WSI-NRS), caregiver-reported itch improvement was seen in 60.3% at week 2 and 86.3% at the last observation. Dynamic Pruritus Score-25 improvement was detectable from 10 minutes after the first application.

“These results support safe and efficacious use of roflumilast cream 0.05% in patients aged as young as 3 months, a population with substantial disease burden and limited evidence-based treatment options,” wrote Lawrence Eichenfeld, MD, and colleagues, in their conclusion.

Roflumilast 0.15% cream in patients aged 6 and older: regional and clinical sign data

In a vehicle-controlled phase 3 trial of roflumilast cream 0.15% in patients aged 6 years and older with mild-to-moderate AD, the poster examined improvements across all 4 EASI body regions and all 4 EASI clinical signs at weeks 1, 2, and 4.

Among the 884 roflumilast-treated and 453 vehicle-treated patients, roflumilast 0.15% produced numerically greater improvement than vehicle in each of the 4 body regions and all 4 clinical signs from Week 1 through Week 4. Improvements were consistent regardless of affected body region, supporting broad-spectrum efficacy across the entire body surface.

Investigators noted 76.1% of patients had moderate disease (vIGA-AD 3) at baseline, with a mean EASI of approximately 13.5, and a mean BSA involvement of 10%.

“These results support that roflumilast cream 0.15% provides rapid and consistent benefit across body regions affected by [atopic dermatitis], offering an advanced targeted topical therapy alternative to commonly used topical therapies,” wrote Alexandra Golant, MD, and fellow investigators, in their conclusion.

References

1. Eichenfield LF, et al. INTEGUMENT-INFANT: once-daily roflumilast cream 0.05% in infants aged 3 to 24 months with atopic dermatitis. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.

2. Grada A, et al. Roflumilast cream 0.15% provides improvement across eczema area and severity index body regions and clinical signs in patients aged ≥6 years with mild-to-moderate atopic dermatitis. Presented at: Revolutionizing Atopic Dermatitis; Nashville, TN; June 17-19, 2026.