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

NCT07265479 ↗

Phase 3 Suspended 187 enrolled Organon and Co
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

EvaluationDrugModalityDoseRoute
Subject Tapinarof Other / unclassified 1 % Topical

Indications