Efficacy and Safety of Topical Indigo Naturalis in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. The aims of this project are:
- To evaluate the efficacy of indigo naturalis ointment in treating AD topically;
- To evaluate the safety of indigo naturalis ointment in treating AD topically;
- To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD;
- To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
详细描述
Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. AD is characterized by itchy and dry skin that affects approximately 5 to 20% of children in the world. Currently, corticosteroids are the most widely prescribed medication in treating AD; however, there are concerns regarding the side effects such as skin atrophy, telangiectasia, striae, folliculitis and adrenocortical suppression that inhibits growth in children. Many patients and families seek complementary and alternative medications such as traditional Chinese medicine (TCM). In TCM, indigo naturalis has been used to treat various infectious and inflammatory skin diseases for hundreds of years. Ancient TCM literature has recorded that indigo naturalis is also effective in treating facial eczema (AD) in infants.
The aims of this project are: (1) To evaluate the efficacy of indigo naturalis ointment in treating AD topically; (2) To evaluate the safety of indigo naturalis ointment in treating AD topically; (3) To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD; (4) To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 and 65 years old, female or male.
- •Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
- •Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
- •An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
- •Female patients of child-bearing age with negative pregnancy test at screening.
- •Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
- •Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0)
- •Willing to comply with study protocol and agree to sign an informed consent form.
排除标准
- •Having a history of topical or systematical hypersensitivity to indigo naturalis or its excipient (e.g. beeswax) in ointment
- •Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
- •Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7 days before the first application of the study medication.
- •Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
- •Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
- •Women who are lactating, pregnant or preparing to be pregnant.
研究组 & 干预措施
Indigo naturalis ointment
- Form: ointment
- Dose: each gram of ointment contains 200µg of indirubin
- Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
干预措施: Indigo naturalis ointment (Drug)
Placebo
- Form: ointment
- Dose: vehicle
- Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6
时间窗: 6 weeks
The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the head ⁄ neck, upper limb, trunk and lower limb body regions. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72. The mean percentage change in EASI = (EASI baseline-EASI post-treat) / EASI baseline x 100%
次要结局
- Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment(6 weeks)
- Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6.(6 weeks)
- The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6.(6 weeks)
- The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6.(6 weeks)
- Clinical-immunological correlation between the treatment outcome and the changes in the level of immunoglobin E (IgE), cytokines, eosinophil count, and C-reactive protein (CRP) in the peripheral blood from baseline to week 6.(6 weeks)
- The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6(6 weeks)
- Physician's Global Assessment (PGA ) at week 6.(6 weeks)
- Subject's Global Assessment (SGA) at week 6.(6 weeks)