RecruitingPhase 3NCT06648772

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

A Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 3 Clinical Study To Evaluate The Efficacy and Safety Of Roflumilast Cream 0.3% (Zoryve®) in the Treatment of Plaque Psoriasis In China

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

189 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Plaque Psoriasis

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.

Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Roflumilast Cream 0.3% and a drug called Vehicle cream for people with plaque psoriasis. The study is currently recruiting participants at 31 locations. People eligible for this study include aged 6 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoflumilast Cream 0.3%

Roflumilast Cream 0.3%

DRUGVehicle cream

Vehicle cream

Locations(31)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

People's Hospital of Peking University

Beijing, China

Beijing Children's Hospital, Capital Medical University

Beijing, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Children's Hospital of Hunan Province

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

Affiliated Hospital of Chengde Medical College

Chengde, China

Sichuan Provincial People's Hospital

Chengdu, China

The Second People's Hospital of Chengdu

Chengdu, China

Affiliated Hospital of Chongqing Three Gorges Medical College

Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Sixth People's Hospital of Dongguan

Dongguan, China

Enshi Tujia and Miao Autonomous Prefecture Central Hospital

Enshi, China

Dermatology Hospital of Southern Medical University

Guangzhou, China

Hainan Fifth People's Hospital

Haikou, China

The First People's Hospital of Hangzhou

Hangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Ji'nan Central Hospital

Ji'nan, China

The First Hospital of Jilin University

Jilin City, China

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Jinhua, China

The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Affiliated Hospital of Nantong University

Nantong, China

Sanmenxia Central Hospital

Sanmenxia, China

Shanghai Skin Disease Hospital

Shanghai, China

The Second Affiliated Hospital of South Anhui Medical College

Wuhu, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First People's Hospital of Yancheng

Yancheng, China

Zhengzhou Central Hospital

Zhengzhou, China

Affiliated Hospital of Jiangsu University

Zhenjiang, China

View Full Details on ClinicalTrials.gov

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NCT06648772

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