Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
研究概览
简要总结
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
详细描述
Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.
To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
- •Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
- •Patients were in good general health.
- •Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
排除标准
- •Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
- •Patients had a history of allergy to indigo naturalis.
- •Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
- •Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
研究组 & 干预措施
refined indigo naturalis ointment
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study
干预措施: refined indigo naturalis ointment (Drug)
crude indigo naturalis ointment
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study
干预措施: crude indigo naturalis ointment (Drug)
结局指标
主要结局
Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
时间窗: Baseline and Week 8
The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.
Clearing Percentage of Target Plaque Area
时间窗: Baseline and Week 8
The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.
Percentage Improvement Compared to Baseline in the Target Plaque.
时间窗: Baseline and Week 8
The improvement percentage of the target plaque at the follow-up visit was calculated as: \[(Area of baseline plaque\*PSI of baseline plaque - Area of plaque week 8\*PSI of plaque week 8)/(Area of baseline plaque\*PSI of baseline plaque)\]\*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.
次要结局
- Patients' Rating of the Overall Improvement at Week 8(Baseline and Week 8)
- Patients Preferred Ointment Type.(Week 8)
研究者
Yin-ku Lin
Chief of Department of Traditional Chinese Medicine
Chang Gung Memorial Hospital