Arcutis ZORYVE cream clears 49% of infants’ eczema by Week 4
ZORYVE cream 0.05% demonstrated a vIGA-AD score of 0/1 in 49% of infants (n=96) by Week 4 and achieved itch reduction ≥4 points in 72.7% of participants. Safety profile in 101 infants aged 3–24 months showed no serious adverse events, supporting a Q2 2026 sNDA filing.
1. Trial Design and Population
The open-label INTEGUMENT-INFANT Phase 2 trial enrolled 101 infants aged 3 months to <24 months with mild to moderate atopic dermatitis, administering once-daily ZORYVE® (roflumilast) cream 0.05% over four weeks to assess safety and tolerability.
2. Efficacy Outcomes
Among 96 infants completing four weeks, 49% achieved a vIGA-AD score of 0 (Clear) or 1 (Almost Clear), 34.4% met a ≥2-grade improvement, 58.3% achieved EASI-75, and 72.7% recorded ≥4-point itch reduction on the WSI-NRS by Week 4; 67.5% of those with scalp involvement attained vIGA-scalp success.
3. Safety Profile
Treatment was well tolerated with 97.9% of infants showing no application site irritation; most frequent adverse events (≥3%) included diarrhea, nasopharyngitis, upper respiratory infection, and vomiting, with one discontinuation and no serious adverse events reported.
4. Regulatory Outlook
These data form the basis for a planned supplemental New Drug Application for ZORYVE cream 0.05% in infants aged 3 to <24 months, expected in Q2 2026, and expand clinical evidence supporting ZORYVE across age groups and disease severities.