NL-OMON54877已完成不适用
A phase I/IIa, single-centre, randomized, double-blind, placebo-controlled, parallel treated dose-ranging study with a safety run-in period to assess the safety and efficacy of topical XZ.700 in patients with mild to moderate atopic dermatitis - XZ.700 in patients with mild to moderate atopic dermatitis
Micreos Human Health0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65
- •years (during covid-19 restriction period subjects will be included from 18 to
- •54 years of age inclusive) of age, inclusive. The health status is verified by
- •absence of evidence of any clinically significant active or uncontrolled
- •chronic disease other than AD that potentially may influence the adherence to
- •the study and/or assessments in the study, following a detailed medical history
- •and a complete physical examination including vital signs, 12-lead ECG,
- •hematology, blood chemistry, virology and urinalysis;
- •2. Diagnosed with AD according to the Hanifin criteria (Hanifin 1980);
- •3. Suitable target lesion (preferably the antecubital fossa) defined as an
- •eczema lesion of 0,5%*BSA*5% (excluding the face and hands) with at least mild
- •erythema and mild induration at screening and baseline day 1;
- •4. Target lesion is cultured positive for S. aureus on two consecutive
- •occasions during the screening period;
- •5. Extent of lesional, atopic dermatits affected skin for 1%*BSA*15%; at
- •screening and baseline (day 1);
- •6. Willing to refrain from washing the target lesion 12 hours before every
- •study visit that includes microbiology samples;
- •7. Willing to use microbiome friendly wash solution as provided by sponsor and
- •refrain from other products for washing from screening until end-of-study;
- •8. Willing to refrain from all topical products for lesional skin during the
- •treatment period;
- •9. Subjects and their Partners of childbearing potential must use effective
- •contraception, for the duration of the study and for 3 months after the last
- •10. Able to Participate and willing to give written informed consent and to
- •comply with the study restrictions;
- •11. Has the ability to communicate well with the Investigator in the Dutch
排除标准
- •1. Any current and / or recurrent clinically significant skin condition which
- •will interfere with the clinical findings of the study as assessed by the
- •investigator;
- •2. Ongoing use of prohibited atopic dermatitis treatments. Washout periods
- •prior to baseline (first dose of the study drug) are as follows:
- •- All atopic dermatitis lesions: any topical medication (prescription or
- •over-the-counter [OTC]): 14 days. For emollients target lesion only: 7 days. On
- •other atopic dermatitis lesions use of emollients is allowed, however must be
- •discontinued prior to Day 1.
- •- Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic
- •AD drugs: 4 weeks
- •- Phototherapy: 3 weeks
- •- Biologics: 5 half-lives of the drug
- •- Systemic antibiotics: 14 days
- •3. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
- •3 weeks of enrolment and/or not willing to refrain from these during the study;
- •4. Known hypersensitivity to the investigational compound or its excipients;
- •5. Pregnant, a positive pregnancy test, intending to become pregnant, or
- •breastfeeding;
- •6. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times a year;
- •7. Loss or donation of blood over 500 mL within three months (males) or four
- •months (females) prior to screening;
- •8. A positive drug and/or alcohol test at screening (rescreening is allowed).
- •9. Subject has a body temperature of >38.0 °C at any visit, only during
- •SARS-CoV-2 measures;
- •10. Only during SARS-CoV-2 measures: Subject has a BMI of >30 kg/m2
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