NCT07265479

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 3 Months – 23 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tapinarof cream, 1%	Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.
DRUG	Vehicle Cream	Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Timeline

• Start date: 2025-12-29
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-12-04
• Last updated: 2026-04-17

Locations

48 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study