NCT02330237已完成2 期
Safety and Efficacy of Natural Gel Combination and Hair Mask of Plant Origin in Patients With Psoriasis: A Randomized, Double-Blind, Placebo (Vehicle) Controlled
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Modified Psoriasis Assessment severity index
研究概览
简要总结
The aim of the study is to evaluate the safety and the therapeutic activity of the combination of Natural Gel combination and hair mask of plant origin in patients with mild to moderate plaque psoriasis.
详细描述
This is a random, double blind placebo -vehicle- controlled study. Patients recruiting and inclusion into the study is well defined. Expert on site monitoring will assure execution of all assignments as detailed in the protocol (screening, consent form, double-blind group assignment) .
Statistical analysis
- It is calculated that 52 patients will be needed for this study.
- Type I error probability associated with this test is 0.05 .
- Uncorrected chi square will be used to assess changes in the measured variables.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
- •Male and female ≥ 18 years old.
- •Subject is capable of giving a written informed consent.
排除标准
- •Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
- •Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
- •Subjects with any other type of psoriasis but vulgaris (plaque ).
- •Use of investigational agents < 30 days prior to the study.
- •Low compliance.
- •Subjects who are mentally or physically unable to comply with all aspects of the study.
- •Pregnant women.
- •Known allergic reaction to fragrance or any ingredient of the test products.
- •Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
- •A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.
研究组 & 干预措施
patients
Active Comparator
natural gels
干预措施: natural gels (Drug)
subjects
Placebo Comparator
These patients will receive that placebo (vehicle) products.
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Psoriasis Assessment severity index
时间窗: up to 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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