What is MC2-01 cream studying for plaque psoriasis?

MC2-01 cream is being studied to evaluate its safety and effectiveness in treating plaque psoriasis in Chinese adults. This clinical trial compares MC2-01 cream with CAL/BDP gel and a vehicle cream to understand how well it controls psoriasis symptoms. The sponsor leading this research is Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Who may be eligible for this plaque psoriasis clinical trial?

Adults aged 18 years or older with a clinical diagnosis of stable plaque psoriasis affecting the body are eligible. Both males and females can participate, but women of childbearing potential must use effective contraception. Participants should not have recent treatments that might affect psoriasis assessment. Please review eligibility criteria for more details.

Is there any cost to participate in this plaque psoriasis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07357831

A Randomized, Multicenter, Investigator-Blind Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CALBDP Gel and Vehicle In Chinese Subjects With Plaque Psoriasis

Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-01-27

537

Participants Needed

Research Sites

9 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of MC2-01 cream for treating plaque psoriasis in Chinese adults aged 18 years and older. This phase 3, multi-center, randomized, and investigator-blinded study compares MC2-01 cream to CALBDP gel and a vehicle cream in participants with stable plaque psoriasis affecting the body andor scalp. The study includes a screening period, treatment period, and safety follow-up to assess outcomes carefully. Participants will apply one of the study treatmentsMC2-01 cream, MC2-01 vehicle cream, or CALBDP gelonce daily for 8 weeks. Each treatment contains calcipotriene and betamethasone dipropionate in specified concentrations, except the vehicle cream which does not contain active ingredients. The study treatment is delivered topically to areas affected by plaque psoriasis, primarily on the trunk, limbs, and scalp. Throughout the study, participants will attend visits to evaluate their psoriasis using tools like the Physicians Global Assessment PGA and modified Psoriasis Area and Severity Index mPASI. Other assessments include safety monitoring through skin reactions, vital signs, and ECGs. Researchers will also gather information on treatment convenience and perform follow-up safety checks after treatment ends. Total involvement includes screening, 8 weeks of treatment, and additional safety follow-up to monitor participant well-being.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Understand and agree to participate voluntarily, and able to complete all study visits
Aged 18 years or older, male or female
Clinically diagnosed plaque psoriasis on the body (trunk and/or limbs) with disease duration of at least 6 months, stable for the last 4 weeks
Body surface area (BSA) affected by psoriasis from 2% to 30% on trunk and/or limbs, total BSA not exceeding 30% if scalp is involved
Physician's Global Assessment (PGA) score of 2 or 3 on trunk and/or limbs
Modified Psoriasis Area and Severity Index (mPASI) score of 3 or higher
Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and 3 months after treatment; men must agree to contraception and avoid sperm donation during this time

You will not qualify if you...

Diagnosed with non-stable or non-plaque psoriasis
Other inflammatory skin conditions in treatment area that may affect psoriasis assessment
Significant pigment changes, scarring, sunburn, or other skin abnormalities in treatment area
Treatment area exposed to natural/artificial light or tanning devices within 4 weeks before baseline or during study
Known allergy to any component of study or control products
History of hypercalcemia, vitamin D toxicity, severe kidney or liver impairment
Use of biological systemic treatments or other systemic agents affecting psoriasis within 4 weeks before baseline or planned 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 HIV, hepatitis B or C, or syphilis infection
Any medical condition posing safety risks or interfering with study assessments
Planned changes in treatments affecting psoriasis during study
Participation in other interventional trials within 3 months or 5 half-lives prior to study
Pregnant, breastfeeding, or planning pregnancy during study
Major surgery within 4 weeks before baseline or planned during study
Active infections requiring systemic antibiotics, antifungals, or antivirals within 7 days before baseline
Cancer diagnosed within 5 years before first dose

Research Team

Huadong Medicine

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