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Plaque PsoriasisPhase 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 Phase 3 study testing MC2-01 cream and CAL/BDP Gel in people with Plaque Psoriasis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 55 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
MC2-01 cream and CAL/BDP Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
539 participants
Where
55 sitesChina
Study dates
30 Dec 2025to 19 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Aged ≥ 18 years at the time of signing the ICF, male or female.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Be diagnosed with non-stable psoriasis or non-plaque psoriasis.
  • Presence of other inflammatory skin conditions in the treatment site that may confound the investigator's assessment of psoriasis.
  • Presence of significant pigmentary changes, scarring, sunburn, and other skin abnormalities in the treatment site that affect the assessment of psoriasis efficacy.
  • 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.
  • Known hypersensitivity to any component of the test product or control product.
  • 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).
Show all 19Show fewer
  • Systemic treatment with biological therapies.
  • 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.
  • 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.
  • 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.
  • Clinical signs of skin infection with bacteria, viruses, or fungi
  • Known Human Immunodeficiency Virus (HIV) infection, or hepatitis B, or hepatitis C, or syphilis.
  • 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.
  • 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.
  • 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.
  • Women who are pregnant, lactating, or planning to become pregnant during the study.
  • Major surgery within 4 weeks before the baseline visit or planned major surgery during the study.
  • Active infection requiring the application of oral or intravenous antibiotics, antifungals, or antivirals within 7 days before the baseline visit.
  • Cancer within 5 years before the first dose of this study

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

China55 sites

  • Inner Mongolia Baogang Hospital

    Baotou, Inner Mongolia

  • Beijing Aerospace General Hospital

    Beijing, Beijing Municipality

  • Bejjing Friendship Hospital，Capital Medical University

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Chengde Medical University Affiliated Hospital

    Chengde, Hebei

  • Chengdu Second People 's Hospital

    Chengdu, Sichuan

  • Chongqing Hospital of Traditional Chinese Medicine

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • Southern Medical University Dermatology Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Sun Yat-sen University Third Affiliated Hospital

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • Haikou Fifth People's Hospital

    Haikou, Hainan

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

  • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Hunan University of Medicine General Hospital

    Huaihua, Hunan

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

  • Jinan Central Hospital

    Jinan, Shandong

  • Jingzhou Central Hospital

    Jingzhou, Hubei

  • Jining NO.1 People's Hospital

    Jining, Shandong

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu

  • Henan University of Science and Technology Second Affiliated Hospital

    Luoyang, Henan

  • Nanyang Central Hospital

    Nanyang, Henan

  • The First Affiliated Hospital of NingBo University

    Ningbo, Zhejiang

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality

  • Shenyang Medical College Affiliated Central Hospital

    Shenyang, Liaoning

  • Shenzhen Nanshan District People's Hospital

    Shenzhen, Guangdong

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong

  • First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shiyan Renmin Hospital

    Shiyan, Hubei

  • Taihe Hospital

    Shiyan, Hubei

  • Suining Central Hospital

    Suining, Sichuan

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu

  • Taiyuan Central Hospital

    Taiyuan, Shanxi

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • Wuxi People's Hospital

    Wuxi, Jiangsu

  • Wuxi Second People's Hospital

    Wuxi, Jiangsu

  • The Second Affiliated Hospital of Xiamen medical college

    Xiamen, Fujian

  • The Affiliated Hospital Of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Yancheng NO.1 People's Hospital

    Yancheng, Jiangsu

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

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

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.

Being tested
MC2-01 cream, MC2-01 vehicle, CAL/BDP Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MC2-01 creamDrug

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

  • MC2-01 vehicleDrug

    Vehicle Cream

  • CAL/BDP GelDrug

    calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

Study groups in NCT07357831
Study groupRoleWhat they receive
MC2-01 CreamExperimentalMC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Receives: Drug: MC2-01 cream
MC2-01 VehicleSham comparatorOne application daily for 8 weeks.
Receives: Drug: MC2-01 vehicle
CAL/BDP GelActive comparatorCalcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Receives: Drug: CAL/BDP Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physician's Global Assessment (PGA) success rate on the body (trunk and/or limbs) after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis

    Proportion of subjects who achieve PGA treatment success (defined as a score of 0 or 1 plus a minimum 2-point decrease in PGA score from baseline) on the body (trunk and/or limbs) compared to after 8 weeks of treatment

    Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening.

    Measured: Baseline and 8-week

Secondary outcomes (7)

  1. Percent change from baseline in mPASI after 8 weeks of treatment

    To evaluate the improvement in Modified Psoriasis Area and Severity Index (mPASI) after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis.

    The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.

    Measured: Baseline and 8-week

  2. Assessment of Psoriasis Treatment Convenience Scale (PTCS) at week 8 of treatment

    Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10.

    How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10.

    Measured: 8-week

  3. PGA success rate on the scalp psoriasis after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis

    Proportion of subjects with scalp psoriasis involved, PGA ≥2 and ≥0.3% body surface area (BSA) at baseline who achieve PGA treatment success on the scalp psoriasis after 8 weeks of treatment

    Measured: Baseline and 8-week

  4. Safety with MC2-01 cream in subjects with plaque psoriasis

    Number of participants with adverse events and serious adverse events will be assessed.

    Measured: 8-week

  5. Incidence of local skin reactions

    Number of subjects that experience an local skin reactions by investigator assessment and local skin reactions reported as adverse events will be assessed

    Measured: 8 week

  6. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Single measurements of 12-lead ECGs were obtained at Baseline to week 8, at any visit post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc).

    Measured: 8 week

  7. Number of Participants With Vital Signs of Potential Clinical Importance

    Body Temperature, Respiration, Pulse, and Blood Pressure were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 8, any visit post-screen.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start30 Dec 2025
  3. Primary completion6 Aug 2026
  4. Study completion19 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357831
Sponsor's protocol ID
HDM3015-301
Status last verified
Aug 2026
First submitted
11 Dec 2025
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MC2-01 cream and CAL/BDP Gel in people with Plaque Psoriasis, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 55 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician's Global Assessment (PGA) success rate on the body (trunk and/or limbs) after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis (time frame: Baseline and 8-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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