A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
研究概览
简要总结
This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene [CAL]/betamethasone [BDP] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.
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 with daily routines. In this trial, the MC2-01 cream will be compared to a marketed calcipotriene [CAL]/betamethasone dipropionate [BDP] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.
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
- None
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
- •Have 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.
- •At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
- •Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day
- •Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.
排除标准
- •Current diagnosis of unstable forms of psoriasis
- •Other inflammatory skin disease in the treatment area
- •Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
- •Planned exposure to natural or artificial sunlight
- •Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;
- •Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;
- •Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to Visit 1/Day 0 during the trial period.
- •Planned initiation of, or changes to concomitant medication that could affect calcium metabolism during the trial;
- •Planned initiation of, or changes to, concomitant estrogen therapy during the trial;
- •Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist 1/Day 0 and during the trial period;
- •Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;
- •Systemic treatment with biological therapies
- •Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;
- •Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns
- •Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;
- •Clinical signs of skin infection with bacteria, viruses, or fungi;
- •Known human immunodeficiency virus [HIV] infection;
- •Known or suspected of hypersensitivity to any component of the test product or reference product;
- •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 cream (CAL and BDP, w/w 0.005%/ 0.064%).
干预措施: MC2-01 Cream (Drug)
CAL/BDP combination
CAL/BDP ointment (w/w 0.005%/0.064%).
干预措施: CAL/BDP combination (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
时间窗: Week 8
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
时间窗: Week 8
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
时间窗: Week 8
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
时间窗: Week 8
Geometric Mean for Maximum Plasma Concentration \[Cmax\] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
次要结局
- Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment(Week 4)
- Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium(Baseline and week 8)
- Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine(Baseline and week 8)
- Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment(Week 8)
- Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion(Baseline and week 8)