drugset / Trial / NCT07265479
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
Timeline
- Start
- 2025-12-29
- Primary completion
- 2027-08
- Completion
- 2027-08
Outcome
Outcome not reported
Stopped: “As a precaution, study drug dosing is paused due to a PK finding in OG505-3104. No safety signal or change to the established safety or benefit-risk profile has been identified. The Sponsor is further investigating and assessing the data.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tapinarof | Other / unclassified | 1 % | Topical |