New psoriasis cream shows promise in major trial

NCT ID NCT07357831

Disease control Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 3 trial tests a new cream (MC2-01) containing two active ingredients for plaque psoriasis in Chinese adults. About 537 participants will use either the new cream, a standard gel, or a placebo cream for 8 weeks. The main goal is to see if the new cream clears skin better than the alternatives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MC2-01 cream (calcipotriene and betamethasone dipropionate combination)
What this could lead to: If successful, this cream could offer a more effective or convenient topical treatment option for plaque psoriasis, potentially improving skin clearing.
What could go wrong: This is a late-stage trial, but results may not apply to all populations. The cream might not be significantly better than existing gels, and side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

539 people

The number who actually took part.

Started

Dec 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the informed consent form (ICF), and be able to complete all visits as required by the protocol. 2. Aged ≥ 18 years at the time of signing the ICF, male or female. 3. Clinical diagnosis of plaque psoriasis with involvement of the body (trunk and/or limbs) before the first dose of this study, with a disease duration of ≥ 6 months and stable for the last 4 weeks. 4. Subjects are required to meet the following requirements at screening and baseline: * BSA of psoriatic involvement on body (trunk and/or limbs) ranging from 2% to 30%, with total BSA not exceeding 30% if scalp involvement is present; * Body (trunk and/or limbs) PGA score of 2 or 3; * mPASI score ≥3. 5. Female of childbearing potential (WOCBP) subjects with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. WOCBP and male subjects who have not received a vasectomy must agree to take at least one effective method of contraception, including oral/implantable/injectable/transdermal contraceptive, intrauterine device, bilateral tubal ligation or occlusion, vasectomy, and barrier contraception (used correctly and throughout sexual intercourse), from the first dose of the study drug through 3 months after the last dose of the study drug. If the subject is routinely abstinent, the subject may use this form of contraception, but should choose a reliable form of contraception as mentioned above when the subject is no longer abstinent. Male subjects must not donate sperm from the first dose of the study drug until 3 months after the last dose. Exclusion Criteria: 1. Be diagnosed with non-stable psoriasis or non-plaque psoriasis. 2. Presence of other inflammatory skin conditions in the treatment site that may confound the investigator's assessment of psoriasis. 3. Presence of significant pigmentary changes, scarring, sunburn, and other skin abnormalities in the treatment site that affect the assessment of psoriasis efficacy. 4. The treatment site is expected to be excessively exposed to natural/artificial light, tanning beds, or other LEDs within 4 weeks before the baseline visit and throughout the study. 5. Known hypersensitivity to any component of the test product or control product. 6. Current or prior hypercalcemia, vitamin D toxicity, severe renal insufficiency (Creatinine clearance \<30 mL/min using the Cockcroft-Gault formula), or severe hepatic impairment (according to Child-Pugh C classification). 7. Systemic treatment with biological therapies. 8. Use of systemic agents for the treatment of psoriasis or any other agents which may influence the efficacy assessment of psoriasis within 4 weeks before the baseline visit or planned use during the study. 9. Use of psoralen plus ultraviolet A (PUVA) or ultraviolet B (UVB) phototherapy within 4 weeks before the first dose of this study or planned use during the study. 10. Use of topical medications for the treatment of psoriasis or any other agents which may influence the efficacy assessment of psoriasis within 2 weeks before the baseline visit. 11. Clinical signs of skin infection with bacteria, viruses, or fungi 12. Known Human Immunodeficiency Virus (HIV) infection, or hepatitis B, or hepatitis C, or syphilis. 13. Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial. 14. Planned initiation or change in the use of an existing treatment that, in the opinion of the investigator, can affect the assessment of psoriasis efficacy. 15. Current participation in any other interventional clinical trial; or previous participation in a pharmaceutical clinical trial within 3 months or 5 half-lives (whichever is longer) or any other interventional clinical trial within 3 months prior to the first dose of this study. 16. Women who are pregnant, lactating, or planning to become pregnant during the study. 17. Major surgery within 4 weeks before the baseline visit or planned major surgery during the study. 18. Active infection requiring the application of oral or intravenous antibiotics, antifungals, or antivirals within 7 days before the baseline visit. 19. Cancer within 5 years before the first dose of this study

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

Contacts and locations

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China
Beijing Aerospace General Hospital

Beijing, Beijing Municipality, China
Bejjing Friendship Hospital，Capital Medical University

Beijing, Beijing Municipality, China
Chengde Medical University Affiliated Hospital

Chengde, Hebei, China
Chengdu Second People 's Hospital

Chengdu, Sichuan, China
Chongqing Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, China
First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, China
Guangzhou First People's Hospital

Guangzhou, Guangdong, China
Haikou Fifth People's Hospital

Haikou, Hainan, China
Hangzhou First People's Hospital

Hangzhou, Zhejiang, China
Henan University of Science and Technology Second Affiliated Hospital

Luoyang, Henan, China
Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China
Hunan University of Medicine General Hospital

Huaihua, Hunan, China
Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China
Jinan Central Hospital

Jinan, Shandong, China
Jingzhou Central Hospital

Jingzhou, Hubei, China
Jining NO.1 People's Hospital

Jining, Shandong, China
Nanyang Central Hospital

Nanyang, Henan, China
Sanmenxia Central Hospital

Sanmenxia, Henan, China
Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China
Shenyang Medical College Affiliated Central Hospital

Shenyang, Liaoning, China
Shenzhen Nanshan District People's Hospital

Shenzhen, Guangdong, China
Shenzhen Second People's Hospital

Shenzhen, Guangdong, China
Shiyan Renmin Hospital

Shiyan, Hubei, China
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
Southern Medical University Dermatology Hospital

Guangzhou, Guangdong, China
Suining Central Hospital

Suining, Sichuan, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China
Sun Yat-sen University Third Affiliated Hospital

Guangzhou, Guangdong, China
Suzhou Municipal Hospital

Suzhou, Jiangsu, China
Taihe Hospital

Shiyan, Hubei, China
Taiyuan Central Hospital

Taiyuan, Shanxi, China
The Affiliated Hospital Of Xuzhou Medical University

Xuzhou, Jiangsu, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China
The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China
The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China
The First Affiliated Hospital of NingBo University

Ningbo, Zhejiang, China
The First Hospital of Jiaxing

Jiaxing, Zhejiang, China
The First Hospital of Jilin University

Changchun, Jilin, China
The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China
The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China
The Second Affiliated Hospital of Xiamen medical college

Xiamen, Fujian, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, China
Wuxi People's Hospital

Wuxi, Jiangsu, China
Wuxi Second People's Hospital

Wuxi, Jiangsu, China
Xiangya Hospital of Central South University

Changsha, Hunan, China
Yancheng NO.1 People's Hospital

Yancheng, Jiangsu, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China
Zhengzhou Central Hospital

Zhengzhou, Henan, China
Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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