NCT03907228Unknown不适用
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of RHT-3201 for the Evaluation of Efficacy and Safety on the Children With Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
研究概览
简要总结
The study's objective is to confirm that RHT-3201 reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 1 to 12 years, as compared to placebo. It will also be examined if the RHT-3201 treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients and patients's parents or legal guardian have signed the informed consent.
- •Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajka criteria
- •Patients experienced AD symptoms for at least 6 months
- •SCORAD index of 20-40, both inclusive
排除标准
- •Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
- •Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiring systemic treatment within 2 weeks of baseline (Localized molluscum contagiosum with <20 lesions and viral warts are generally not reasons for exclusion.)
- •Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
- •Use of medications or treatments before baseline
- •Treated with corticosteroids, immunosuppressive treatment within 4 weeks of baseline
- •Treated with herbal medicines and health functional foods related to atopic dermatitis within 4 weeks of baseline
- •Treated with phototherapy treatments to atopic dermatitis within 4 weeks of baseline
- •Treated with probiotics within 4 weeks of baseline
- •Treated with systemic antibiotics within 2 weeks of baseline
- •Treated with topical steroids, topical immunomodulators, oral antihistamines, and topical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma, no washout required if doses is stable)
- •Medical history of infectious intestinal disease within 2 weeks before screening
- •History of hypersensitivity to components contained in study product (Lactobacillus rhamnosus)
- •Participation in any other investigational drug study in which receipt of an investigational study drug or health functional food within the past 4 weeks before screening (or, if known, administered within 5 times the half-life)
- •Patients who are considered to be unacceptable in this study under the opinion of the investigator
研究组 & 干预措施
Placebo
Placebo Comparator
Dextrose Anhydrous
干预措施: RHT-3201 (Dietary Supplement)
RHT-3201
Experimental
Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)
干预措施: RHT-3201 (Dietary Supplement)
结局指标
主要结局
Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
时间窗: after 12-week treatment
Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
次要结局
- Proportion of participants achieving at least a 50%, 75% reduction in EASI(after 12-week treatment)
- Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12(after 4, 8 and 12 week treatment)
- Change from baseline in numeric rating scale (NRS)(after 4, 8 and 12 week treatment)
- Change from baseline in Dermatology Family Impact (DFI)(after 4, 8 and 12 week treatment)
- Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)(after 4, 8 and 12 week treatment)
- Number of days with or without topical corticosteroids(after 4, 8 and 12 week treatment)
- Change from baseline in SCORAD total score(after 4 and 8 week treatment)
- Change from baseline in SCORAD subjective score(after 4, 8 and 12 week treatment)
- Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)(after 12-week treatment)
- Incidence of adverse event (AE)'s(From Baseline through Week 12 (entire study))
- Change from baseline in SCORAD objective score(after 4, 8 and 12 week treatment)
- Change from baseline in Eczema Area and Severity Index (EASI)(after 4, 8 and 12 week treatment)
- Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction(after 12-week treatment)
- Quantity of emollients(after 4, 8 and 12 week treatment)
- Proportion of participants using topical corticosteroids and quantity of topical corticosteroids(after 4, 8 and 12 week treatment)
- Drop-out rate using topical corticosteroids(after 4, 8 and 12 week treatment)
研究者
研究点 (1)
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