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
Latest Information Update: 13 Jun 2025
At a glance
- Drugs Roflumilast (Primary)
- Indications Atopic dermatitis; Eczema
- Focus Adverse reactions
- Acronyms INTEGUMENT-INFANT
- Sponsors Arcutis Biotherapeutics
Most Recent Events
- 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