Trial Profile

A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 13 Jun 2025

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At a glance

10 Jun 2025 According to an Arcutis Biotherapeutics media release, the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a four-week period.
10 Jun 2025 Status changed from not yet recruiting to recruiting, according to an Arcutis Biotherapeutics media release.
05 Jun 2025 New trial record

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