NCT05014568

Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	tapinarof cream, 1%	applied topically once daily
DRUG	Vehicle cream	applied topically once daily

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-03-30
• Completion: 2023-04-07
• First posted: 2021-08-20
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

67 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study