Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

Phase 3 Completed 190 enrolled Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.

Timeline

Start: 2024-11-14
Primary completion: 2025-10-13
Completion: 2025-10-15

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roflumilast	Small molecule	0.3 %	Topical

Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

Summary

Timeline

Drugs

Indications