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A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psoriasis Subjects
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Summary
This is a multi-center, randomized, investigator-blinded, calcipotriol and betamethasone dipropionate gel and vehicle-controlled phase 3 clinical study to evaluate the efficacy and safety of MC2-01 cream in the treatment of Chinese plaque psoriasis to assess the efficacy and safety of MC2-01 cream in Chinese subjects aged ≥ 18 years with plaque psoriasis. This study includes a screening period, a treatment period, and a safety follow-up period.
Official title: A Randomized, Multicenter, Investigator-Blind Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Chinese Subjects With Plaque Psoriasis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
537
Start Date
2025-12-26
Completion Date
2026-12-17
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
MC2-01 vehicle
Vehicle Cream
CAL/BDP Gel
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
Locations (55)
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China
Bejjing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Xiamen medical college
Xiamen, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Third Affiliated Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Nanshan District People's Hospital
Shenzhen, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Haikou Fifth People's Hospital
Haikou, Hainan, China
Chengde Medical University Affiliated Hospital
Chengde, Hebei, China
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan University of Science and Technology Second Affiliated Hospital
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Shiyan Renmin Hospital
Shiyan, Hubei, China
Taihe Hospital
Shiyan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan University of Medicine General Hospital
Huaihua, Hunan, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, China
Yancheng NO.1 People's Hospital
Yancheng, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Jining NO.1 People's Hospital
Jining, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Chengdu Second People 's Hospital
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The First Affiliated Hospital of NingBo University
Ningbo, Zhejiang, China