A Randomized, Double-blind, Placebo Controlled Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Omiganan in Patients With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion)
研究概览
简要总结
To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
- •AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
- •Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
- •Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
研究组 & 干预措施
CLS001 topical gel, 2.5%
干预措施: CLS001 (Drug)
CLS001 topical gel 1%
干预措施: CLS001 (Drug)
Vehicle gel
干预措施: Vehicle (Drug)
结局指标
主要结局
Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion)
时间窗: 42 Days
Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion
Clinical assessment (Change in patient symptoms over time using pruritis VAS)
时间窗: 42 Days
Change in patient symptoms over time using pruritis VAS
Clinical Assessment (Change in lesion size over time)
时间窗: 42 Days
Change in lesion size over time
Clinical assessment (Change in patient SCORAD scale score over time)
时间窗: 42 Days
Change in patient SCORAD scale score over time
次要结局
- Safety Assessment (Adverse events)(42 days)