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MC2-01 cream compared with calcipotriol/betamethasone gel for plaque psoriasis

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

PHASE3 · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · NCT07357831

This study will see if MC2-01 cream helps adults with plaque psoriasis as well as calcipotriol/betamethasone gel or a non-active cream.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment537 (estimated)
Ages18 Years and up
SexAll
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
Locations55 sites (Wuhu, Anhui and 54 other locations)
Trial IDNCT07357831 on ClinicalTrials.gov

What this trial studies

This is a randomized, investigator-blinded phase 3 trial in Chinese adults with plaque psoriasis comparing topical MC2-01 cream to an active calcipotriol/betamethasone gel and to vehicle. Eligible participants are aged 18 or older with stable plaque psoriasis affecting 2–30% body surface area, a body PGA of 2–3, and mPASI ≥3. Participants are randomized across multiple centers, treated during a defined treatment period, and followed for safety. Study outcomes include changes in lesion severity scores (for example PGA and mPASI) and monitoring of safety and tolerability.

Who should consider this trial

Good fit: Adults (≥18 years) with stable plaque psoriasis involving 2–30% BSA, body PGA 2–3, mPASI ≥3, who can attend study visits and comply with contraception rules if applicable are ideal candidates.

Not a fit: People with non-plaque psoriasis types, unstable or very extensive disease outside the BSA limits, or who cannot meet visit or contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, MC2-01 cream could provide an effective topical option with comparable or improved tolerability and convenience versus the existing calcipotriol/betamethasone gel.

How similar studies have performed: Fixed-combination calcipotriol plus betamethasone formulations are well established and have shown efficacy in many prior trials, while MC2-01 represents a new cream formulation being directly compared to the established gel and vehicle.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Wuhu, Anhui and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Plaque Psoriasis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.