Actively Recruiting
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
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-01-27
537
Participants Needed
55
Research Sites
50 weeks
Total Duration
On this page
Sponsors
H
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead Sponsor
M
MC2 Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study purpose, agree to participate, sign informed consent, and can complete all visits
- Aged 18 years or older, any gender
- Clinically diagnosed with plaque psoriasis affecting the body (trunk and/or limbs) for 6 months or more and stable for at least 4 weeks
- Body surface area of psoriatic involvement between 2% and 30%; total BSA not exceeding 30% if scalp is involved
- Body (trunk and/or limbs) Physician's Global Assessment (PGA) score of 2 or 3
- Modified Psoriasis Area and Severity Index (mPASI) score of 3 or higher
- Women of childbearing potential must have negative pregnancy tests at screening and baseline
- Both women of childbearing potential and men without vasectomy must agree to use effective contraception during the study and for 3 months after the last dose
- Men must not donate sperm during the study and for 3 months after the last dose
You will not qualify if you...
- Diagnosed with non-stable or non-plaque psoriasis
- Other inflammatory skin conditions at treatment site affecting psoriasis assessment
- Significant skin changes like scarring, sunburn, or pigment changes at treatment site
- Treatment site exposed to intense natural or artificial light including tanning beds within 4 weeks before baseline or during study
- Known allergy to any ingredients in study or control products
- History of hypercalcemia, vitamin D toxicity, severe kidney or liver problems
- Use of biological therapy for psoriasis
- Use of systemic treatments or agents affecting psoriasis within 4 weeks before baseline or planned use during study
- Use of PUVA or UVB phototherapy within 4 weeks before first dose or planned during study
- Use of topical psoriasis treatments within 2 weeks before baseline
- Clinical signs of skin infection
- Known infection with HIV, hepatitis B or C, or syphilis
- Any chronic or acute medical condition that risks safety or affects study assessments
- Planned change in existing treatments that may affect psoriasis assessment
- Participation in other interventional clinical trials recently or currently
- Pregnant, breastfeeding, or planning pregnancy during study
- Major surgery within 4 weeks before baseline or planned during study
- Active infection requiring antibiotics, antifungals, or antivirals within 7 days before baseline
- Cancer diagnosis within 5 years before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 55 locations
1
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
2
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Bejjing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
7
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
8
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
9
The Second Affiliated Hospital of Xiamen medical college
Xiamen, Fujian, China
Actively Recruiting
10
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
11
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Actively Recruiting
12
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
13
Sun Yat-sen University Third Affiliated Hospital
Guangzhou, Guangdong, China
Actively Recruiting
14
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
15
Shenzhen Nanshan District People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
16
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
17
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Actively Recruiting
18
Haikou Fifth People's Hospital
Haikou, Hainan, China
Actively Recruiting
19
Chengde Medical University Affiliated Hospital
Chengde, Hebei, China
Actively Recruiting
20
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
21
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
22
Henan University of Science and Technology Second Affiliated Hospital
Luoyang, Henan, China
Actively Recruiting
23
Nanyang Central Hospital
Nanyang, Henan, China
Actively Recruiting
24
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Actively Recruiting
25
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Actively Recruiting
26
Jingzhou Central Hospital
Jingzhou, Hubei, China
Actively Recruiting
27
Shiyan Renmin Hospital
Shiyan, Hubei, China
Actively Recruiting
28
Taihe Hospital
Shiyan, Hubei, China
Actively Recruiting
29
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
30
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
31
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
32
Hunan University of Medicine General Hospital
Huaihua, Hunan, China
Actively Recruiting
33
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
Actively Recruiting
34
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Actively Recruiting
35
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
36
Wuxi People's Hospital
Wuxi, Jiangsu, China
Actively Recruiting
37
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Actively Recruiting
38
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
39
Yancheng NO.1 People's Hospital
Yancheng, Jiangsu, China
Actively Recruiting
40
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Actively Recruiting
41
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Actively Recruiting
42
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
43
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning, China
Actively Recruiting
44
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
45
Jining NO.1 People's Hospital
Jining, Shandong, China
Actively Recruiting
46
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
47
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
48
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Actively Recruiting
49
Chengdu Second People 's Hospital
Chengdu, Sichuan, China
Actively Recruiting
50
Suining Central Hospital
Suining, Sichuan, China
Actively Recruiting
51
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
52
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
53
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
54
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Actively Recruiting
55
The First Affiliated Hospital of NingBo University
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
H
Huadong Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here