NCT02031445终止2 期
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2% in Pediatric Subjects With Mild to Moderate Atopic Dermatitis Followed by an Open Label Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Investigator's Global Assessment
研究概览
简要总结
Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and safety study in subjects with mild to moderate atopic dermatitis.
Following the double blind period, subjects will be allowed to continue treatment with topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2% compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of atopic dermatitis.
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)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, ≥2 years of age and ≤17 years of age, of any race or ethnicity
- •Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 (Hanifin and Rajka, Rothe 1980)
- •Must have AD affecting ≥ 5% total body surface area (TBSA) at Baseline
- •History of AD for at least 3 months prior to Baseline
- •Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline (21 CFR §50.25[c]) and applicable regulations, before completing any study-related procedures
排除标准
- •Use of topical corticosteroids within 7 days prior to Baseline
- •Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (eg, PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
- •Subjects that require systemic therapy for the treatment of atopic dermatitis
- •Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
- •Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
- •Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
- •Women of childbearing potential who are lactating or pregnant as determined by urine pregnancy test at Screening. • History of MRX-6 cream 2% sensitivity or to any component of the test article
- •History of severe anxiety and/or depression; any history of suicide attempt
- •Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
- •Subjects with any screening clinical laboratory result outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician
- •Subjects who, in the opinion of the Investigator, would be non compliant with the visit schedule or study procedures
- •Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
- •Chronic condition(s) which are either unstable or not adequately controlled
- •Use of non-sedating anti-histamines within 7 days of first dose or at any time during study conduct
- •Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
研究组 & 干预措施
Placebo
Placebo Comparator
BID
干预措施: Placebo (Other)
MRX-6
Experimental
BID
干预措施: MRX-6 (Drug)
结局指标
主要结局
Investigator's Global Assessment
时间窗: 4 weeks
次要结局
- Safety(4 weeks)
研究者
研究点 (3)
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