NCT05142774

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 728 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

At the completion of the Week 8 visit of study DMVT-505-3101 (NCT05014568) or study DMVT-505-3102 (NCT05032859) or the Day 28 visit of study DMVT-505-2104 (NCT05186805) (Day 1 \[Baseline\] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to \< 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 48 weeks for rollover subjects (Baseline to Final Visit) with a 1-week Safety Follow-up Period and approximately 52 weeks for direct-enrolling subjects (Screening to Final Visit) with a 1-week Safety Follow-up Period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tapinarof cream, 1%	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.

Timeline

• Start date: 2021-10-28
• Primary completion: 2024-02-29
• Completion: 2024-03-07
• First posted: 2021-12-03
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

112 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study