ZORYVE Cream 56-Week Study Shows 63% Clearance in 2–5 Year-Olds
Arcutis published Phase 3 extension data showing once-daily ZORYVE cream 0.05% maintained and improved efficacy over 56 weeks in 562 children aged 2–5, with 63.1% achieving clear or almost clear skin. Median proactive twice-weekly use sustained disease control for 238 days, with no treatment-related serious adverse events.
1. Study Design and Participants
The INTEGUMENT-OLE Phase 3 open-label extension enrolled 562 children aged 2–5 with mild-to-moderate atopic dermatitis, all of whom had completed a prior four-week trial. Participants applied ZORYVE cream 0.05% once daily for up to 52 weeks, and those achieving clear skin transitioned to a proactive twice-weekly regimen.
2. Efficacy Outcomes
Among the 377 participants completing 56 weeks, 63.1% achieved a vIGA-AD score of clear or almost clear. EASI-75 responses reached 71.9% in continuous users and 76.0% in those switched from vehicle, while 57.9% and 66.3% of respective groups saw ≥4-point itch reduction by study end.
3. Safety and Tolerability
Safety assessments showed treatment-emergent adverse events in 49.8% of participants, mostly mild or moderate; serious adverse events occurred in 3.2% with none treatment-related. Local irritation was absent in ≥97% of assessments, and treatment-related events were reported in only 2.5% of children.
4. Proactive Use and Pediatric Expansion
Children achieving clear skin at or after Week 4 maintained control for a median of 238 days on twice-weekly ZORYVE applications. These long-term data support the company’s pediatric strategy following the FDA approval of ZORYVE cream 0.05% in October 2025 and underscore its potential to address a high unmet need in young atopic dermatitis patients.