Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
研究概览
简要总结
The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.
详细描述
The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.
We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.
This is a double-blind, 4-arm parallel study. The aim of this study is
- To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.
- To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.
- To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.
- To investigate the effects of INEO ointment on the immune system.
- To evaluate the effects of INEO ointment in improving quality of life after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 - 65 years, men or women.
- •Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
- •Plaque psoriasis involving <20% of BSA and with PASI <
- •Female patients of child-bearing age with negative pregnancy test at screening.
- •Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
- •Willingness to comply with study protocol.
- •With signed informed consent form.
排除标准
- •With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
- •With history of sensitivity to Chinese herb.
- •Received systematic treatment for psoriasis within 4 weeks.
- •Received topical treatment for psoriasis within 2 weeks.
- •With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
- •Patients with pustular or erythrodermic psoriasis.
研究组 & 干预措施
Indirubin 200 μg/g
per gram of ointment contains 200 μg of indirubin
干预措施: Indirubin 200μg/g (Drug)
Indirubin 100 μg/g
per gram of ointment contains 100 μg of indirubin
干预措施: Indirubin 100 μg/g (Drug)
Indirubin 50 μg/g
per gram of ointment contains 50 μg of indirubin
干预措施: Indirubin 50 μg/g (Drug)
Indirubin 10 μg/g
per gram of ointment contains 10 μg of indirubin
干预措施: Indirubin 10 μg/g (Drug)
结局指标
主要结局
Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
时间窗: 8 weeks
1. Mean change of total score (range 0-72) 2. Percentage change of PASI 3. Individual scores of scaling, erythema, and elevation by sites 4. Percentage of responder (\>50% of improvement, defined as clinical meaningful) and non-responder (less then 50% of improvement) 5. Percentage of subjects achieving "clear or almost clear" (defined as PASI \>90% of improvement)
次要结局
- Body surface area (BSA)involved(8 weeks)
- Psoriasis Severity Index (PSI)(8 weeks)
- Efficacy in various local skin signs(8 weeks)
- Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:(8 weeks)
- Physician's Global Assessment (PGA)(8 weeks)
- Subject's Global Assessment (SGA)(8 weeks)
- Dermatology Life Quality Index (DLQI) questionnaire(8 weeks)
研究者
Yin-ku Lin
MD., PhD.
Chang Gung Memorial Hospital