Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
← catalyst calendarSponsored by Arcutis Biotherapeutics, Inc. (industry) · ARQT — their whole pipeline →.
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
101actual
Sites
22
Countries
Canada, Dominican Republic, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-09 | actual | When the study began enrolling |
| Primary completion | 2025-12-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-04 | actual | The whole study's end, after follow-up |
| First posted | 2025-05-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Atopic Dermatitis (Eczema)
Intervention
- Drug: ARQ-151 cream 0.05%
Primary outcomes
what the primary-completion date above is the date OFSubject incidence of adverse events
measured 4 weeks
Subject incidence of serious adverse events
measured 4 weeks
Incidence of application site reactions
measured 4 weeks
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