Roflumilast Cream 0.05% Effective for Young Children with Atopic Dermatitis: Study
According to a Phase 3 clinical trial (INTEGUMENT-PED) roflumilast cream 0.05% is effective and safe for children aged 2-5 with mild-to-moderate atopic dermatitis. The treatment demonstrated significant improvements in key measures, including EASI-75, vIGA-AD, and WI-NRS Success, highlighting its potential as a valuable option for pediatric patients. The trial was recently published in the Pediatric Dermatology journal conducted by Lawrence F. and fellow researchers.
Atopic dermatitis is a chronic inflammatory skin disease that occurs in millions of young children, frequently causing itching, discomfort, and sleep disturbance. With few effective and safe treatments available for this age group, the results of the trial are important information about a new treatment option.
The INTEGUMENT-PED Phase 3 trial aimed to evaluate the efficacy and tolerability of roflumilast cream 0.05% in 2- to 5-year-old children with mild-to-moderate AD. The trial emphasized major clinical endpoints, namely:
• EASI-75 (at least 75% improvement in Eczema Area and Severity Index score).
• Confirmed Investigator Global Assessment for Atopic Dermatitis Success, as measured by clear or near clear skin.
• Worst Itch Numeric Rating Scale (WI-NRS) Success, evaluating the improvement in pruritus (itch) severity.
The randomized, double-blind, vehicle-controlled study tested the performance of the cream versus a placebo with patients receiving treatment for a set duration under tight clinical supervision.
Key Findings
• The study showed statistically significant improvements across all primary and secondary endpoints:
• EASI-75 response was noted in a significantly greater percentage of children treated with roflumilast cream 0.05% vs. the placebo group.
• vIGA-AD Success demonstrated a greater percentage of patients with clear or near clear skin on active treatment.
• WI-NRS Success reflected significant itching relief, an important symptom affecting quality of life in young children with AD.
• Roflumilast cream was well tolerated with few adverse effects.
The Phase 3 INTEGUMENT-PED study substantiated that roflumilast cream 0.05% is an effective and safe treatment option for atopic dermatitis in children between the age of 2-5 years. With major efficacy improvements in itch relief, skin clearance, and control of disease overall, this topical therapy offers a promising alternative for pediatric patients with atopic dermatitis.
Reference:
Eichenfield, L. F., Serrao, R., Prajapati, V. H., Browning, J. C., Swanson, L., Funk, T., Gonzalez, M. E., Hebert, A. A., Lee, M., Boguniewicz, M., Simpson, E. L., Seal, M. S., Krupa, D., Hanna, D., Snyder, S., Burnett, P., Chu, D. H., Almaraz, E., Higham, R. C., & Berk, D. R. (2025). Efficacy and safety of once‐daily roflumilast cream 0.05% in pediatric patients aged 2–5 years with mild‐to‐moderate atopic dermatitis (INTEGUMENT‐PED): A Phase 3 randomized controlled trial. Pediatric Dermatology. https://doi.org/10.1111/pde.15840
