A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
← catalyst calendarNCT07265479 · readout ≤ 377 d
Sponsored by Organon and Co (industry) · OGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
187actual
Sites
46
Countries
Canada, 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 | 2025-12-29 | actual | When the study began enrolling |
| Primary completion | Aug 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | 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
Interventions
- Drug: Tapinarof cream, 1% — also filed as OG-0505, DMVT-505, GSK2894512A, GSK28994512, STI-1001, WBI-1001
- Drug: Vehicle Cream
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8
measured Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period
measured Baseline to the end of the Open-Label Period, up to 56 weeks.
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