RecruitingPhase 3NCT07357831

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

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


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

537 participants

Start Date

Dec 26, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CAL/BDP Gel, a drug called MC2-01 cream, and others for people with plaque psoriasis. The study is currently recruiting participants at 55 locations. People eligible for this study include aged 18 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

DRUGMC2-01 cream

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

DRUGMC2-01 vehicle

Vehicle Cream

DRUGCAL/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

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NCT07357831


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