NCT06631170

Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

Detailed description

This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	Roflumilast Cream 0.15%	Roflumilast cream 0.15% is applied once daily for 4 weeks
DRUG	Vehicle cream	Vehicle cream is applied once daily for 4 weeks

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-05-27
• Completion: 2025-07-13
• First posted: 2024-10-08
• Last updated: 2025-09-02

Locations

61 sites across 1 country: China