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.

Summary

In 2–5-year-olds with mild-to-moderate atopic dermatitis, once-daily roflumilast 0.05% for 4 weeks significantly improved vIGA-AD (25.4% vs 10.7%), EASI-75 (39.4% vs 20.6%), and itch (35.3% vs 18.0%), with pruritus relief within 24 hours. Safety was favorable with low, mostly mild/moderate TEAEs and minimal local discomfort.

Key Findings

• Week-4 vIGA-AD Success was higher with roflumilast vs vehicle (25.4% vs 10.7%; p<0.0001).
• EASI-75 and WI-NRS Success rates favored roflumilast (39.4% vs 20.6%; p<0.0001 and 35.3% vs 18.0%; nominal p=0.0002).
• Pruritus improvement occurred within 24 hours of first application; TEAEs were low and mostly mild/moderate with minimal stinging/burning (≤0.7%).

Clinical Implications

Roflumilast 0.05% can be considered for 2–5-year-olds with mild-to-moderate AD as a once-daily, well-tolerated option; long-term safety and head-to-head comparisons versus topical steroids or calcineurin inhibitors are still needed.

Limitations

• Short treatment duration (4 weeks) limits assessment of durability and long-term safety
• Vehicle-controlled without active comparator against topical steroids or calcineurin inhibitors

Future Directions

Longer-term safety and efficacy studies, head-to-head comparisons versus topical corticosteroids/calcineurin inhibitors, and real-world effectiveness in diverse populations including moderate-to-severe AD.