Randomized Double Blind Uncontrolled Pilot Study to Compare 2% and 4% AS101 Ointment for the Treatment of Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- BioMAS Ltd
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Modified SCORAD index
研究概览
简要总结
Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.
详细描述
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment.
- •Diseased Body surface area (BSA) ≤ 20%.
- •Male and Female ≥
- •Adequate general health.
- •Signed Informed consent form by the patient or his/her legal guardian.
- •Patient must be able and willing to comply with all protocol requirements.
排除标准
- •Patient who is unable to provide fully informed consent.
- •Pregnant of breast-feeding females.
- •Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
- •Evidence of an infection in the targeted zones.
- •Known sensitivity to any of the drug component.
- •Immunocompromised patients.
- •Concomitant medications such as:
- •Topical corticosteroid within 2 weeks prior to Day 1 visit;
- •Systemic steroids and immunosuppressants within 1 month prior to Day 1 visit; *Systemic anti-histamines and antibiotics within 2 weeks prior to Day 1 visit; *Phototherapy within 4 weeks prior to Day 1 visit;
- •Anticipated exaggerated exposure to sunlight during the whole treatment period and 4 weeks prior to Day 1 visit.
研究组 & 干预措施
Group 1
2% AS101 ointment
干预措施: AS101 ointment (Drug)
Group 2
4% AS101 ointment
干预措施: AS101 ointment (Drug)
结局指标
主要结局
Modified SCORAD index
时间窗: within 6 weeks treatment and 4 weeks follow up
次要结局
- Remission period(within 4 weeks post treatment completion)