A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacodynamics, Safety, Tolerability and Efficacy of Omiganan BID 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
- 80
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (Biomarkers)
研究概览
简要总结
This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.
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 (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- •Confirmed AD diagnosis;
- •Symptoms present for at least 1 year;
- •EASI between 7.1 - 50.0, inclusive at screening;
- •2-20% body surface area (BSA) affected at screening;
- •Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
- •Able to participate and willing to give written informed consent and to comply with the study restrictions;
- •Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
排除标准
- •Any current and / or recurrent clinical significant skin condition other than AD;
- •Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
- •Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
- •Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
- •Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
- •Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
- •Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
研究组 & 干预措施
Omiganan 1%
干预措施: Omiganan (Drug)
Omiganan 1.75%
干预措施: Omiganan (Drug)
Omiganan 2.5%
干预措施: Omiganan (Drug)
Vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamics (Biomarkers)
时间窗: Within 7 Weeks
Local biomarkers sequencing
Pharmacodynamics (Microbiome)
时间窗: Within 7 Weeks
Microbiome analysis
Pharmacodynamics (Microbiology)
时间窗: Within 7 Weeks
Microbiology analysis
Dermatology Life Quality Index (DLQI)
时间窗: Within 7 Weeks
Assessment of health-related quality of life by measuring DLQI
Pharmacodynamics (TEWL)
时间窗: Within 7 Weeks
Transepidermal water-loss assessment
Pharmacodynamics (Thermography)
时间窗: Within 7 Weeks
Skin temperature measurements will be taken
Pharmacodynamics (Cytokines)
时间窗: Within 7 Weeks
Cytokine assessment via blood evaluation
Clinical Evaluation (oSCORAD)
时间窗: Within 7 Weeks
oSCORAD Assessment
Patient-Orientated Outcome Measure (POEM)
时间窗: Within 7 Weeks
Patient Assessment by collecting POEM
eDiary
时间窗: Within 4 Weeks
Singe-Question assessment of pruritus and sleeplessness
Clinical Evaluation (EASI)
时间窗: Within 7 Weeks
EASI Assessment
Clinical Evaluation (IGA)
时间窗: Within 7 Weeks
IGA Assessment
Clinical Photography
时间窗: Within 7 Weeks
Whole body photograph for qualitative and observational record
Pharmacodynamics (TAP)
时间窗: Within 7 Weeks
Analysis of biomarkers captured by Transdermal Analysis Patch
次要结局
- Safety (AE)(Within 7 Weeks)
- Safety (Vital Signs)(Within 7 Weeks)
- Safety (Clinical Laboratory Tests)(Within 7 Weeks)
- Safety (ECG)(Within 7 Weeks)