A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects With Mild-to-Moderate Psoriasis Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 794
- 试验地点
- 3
- 主要终点
- Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8
研究概览
简要总结
This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety and convenience of the MC2-01 cream.
详细描述
The MC2-01 Cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines. In this trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and convenience of this cream to the marketed product. The trial will include a 8-week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided written informed consent
- •Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening
- •Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
- •Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
- •An mPASI score of at least 2
- •Have a treatment area involving 2- 30% of the body surface area (BSA)
排除标准
- •Current diagnosis of unstable forms of psoriasis
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
- •Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
- •Planned exposure to either natural or artificial sunlight
- •History of hypersensitivity to any component of the test product or reference product
- •Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- •Systemic treatment with biological therapies
- •Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and during the trial
- •Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;
- •Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline
- •Clinical signs of skin infection with bacteria, viruses, or fungi
- •Known Human Immunodeficiency Virus (HIV) infection
- •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
研究组 & 干预措施
MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
干预措施: MC2-01 cream (Drug)
Cal/BDP combination
Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
干预措施: Cal/BDP combination (Drug)
Cream vehicle
One application daily for 8 weeks.
干预措施: Cream vehicle (Drug)
结局指标
主要结局
Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8
时间窗: Baseline and 8 weeks
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. The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success.
次要结局
- Percentage Change in mPASI Score(Baseline and 8 weeks)
- Psoriasis Treatment Convenience Scale(8 weeks)