CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 407 enrolled
Drug / intervention
tapinarof cream, 1% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05014568
NCT05014568Phase 3Completed

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults

Organon and Co·interventional·Posted Aug 20, 2021·Updated Sep 4, 2025

In Brief

A Phase 3 clinical trial evaluating tapinarof cream, 1% and Vehicle cream for Atopic Dermatitis. Completed, enrolled 407 participants across 67 sites in 2 countries.

Detailed Summary

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 20, 2021
Enrollment StartSep 1, 2021
Primary CompletionMar 30, 2023
Study CompletionApr 7, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.9 years ago

Interventions

tapinarof cream, 1%drug

applied topically once daily

Vehicle creamdrug

applied topically once daily