NCT03372811已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial (PLANTCOAT-IIb) to Evaluate the Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris
Psoriasis Research Institute of Guangzhou2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2015年6月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Investigator's Static Global Assessment Scale (ISGA) Scores
研究概览
简要总结
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris
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)
盲法说明
Double-blind, no information known before unblinding and study completion
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-70 years old. Both men and women and members of all races and ethnic groups
- •Consistent with diagnostic criteria of stable phase psoriasis vulgaris and have at least two target lesions suitable for evaluation
- •Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
- •ISGA score ≥ 2 (at least mild severity)
- •BSA (stable stage group): 1%≤ to ≤20%
- •Signed a written informed consent document
- •No additional exposure to the sun
排除标准
- •Subjects in pregnancy, preparing for pregnancy or breast feeding
- •History of hyperergic or photosensitivity
- •History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of hepatic, kidney and hematopoietic system, or patients with psychiatric disorders
- •History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa
- •Within 4 weeks prior to randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:
- •Topical treatments
- •PUVA, UVB or Grenz ray therapy.
- •Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
- •Any types of other investigational therapies for psoriasis
- •Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab).
- •Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
- •History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.
研究组 & 干预措施
Vehicle
Placebo Comparator
BID for 8 weeks
干预措施: Vehicle (Drug)
Total coumarin (TC) cream (10%)
Active Comparator
BID for 8 weeks
干预措施: Total coumarin (TC) cream (Drug)
结局指标
主要结局
Investigator's Static Global Assessment Scale (ISGA) Scores
时间窗: Baseline and 8 weeks after treatment
ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
次要结局
- Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores(Baseline and 8 weeks after treatment)
- Dermatology Life Quality Index (DLQI) Scores(Baseline and 8 weeks)
- Psoriasis Disability Index Questionnaire (PDI) Scores(Baseline and 8 weeks)
研究者
研究点 (2)
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