NCT05186805

Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

Open Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis

Detailed description

This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-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%	Tapinarof cream, 1% applied topically once daily

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2022-01-11
• Last updated: 2025-09-05
• Results posted: 2025-09-05

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study