CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 728 enrolled
Drug / intervention
Tapinarof cream, 1%drug
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/NCT05142774
NCT05142774Phase 3Completed
CompareCT.gov

An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis

Organon and Co·interventional·Posted Dec 3, 2021·Updated Aug 13, 2025

In Brief

A Phase 3 clinical trial evaluating Tapinarof cream, 1% for Atopic Dermatitis. Completed, enrolled 728 participants across 112 sites in 2 countries.

Detailed Summary

This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Study Details

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

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedDec 3, 2021
Enrollment StartOct 28, 2021
Primary CompletionFeb 29, 2024
Study CompletionMar 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.6 years ago

Interventions

Tapinarof cream, 1%drug

Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.