NCT03672383已完成不适用
Randomized, Controlled, Observer-blinded, Intra-individual Clinical Trial to Examine the Efficacy and Safety of a New Medical Device (Modified Diprobase Formulation) in Adults With Quiescent Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- AUC of the skin hydration assessed of treatment with the test product compared to untreated
研究概览
简要总结
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Observer-blind
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
- •Patients being willing and able to provide written informed consent to participate in the study;
- •Patients with self-reported history of AD (at least one flare up in the past with mild to moderate intensity), but with no flare-up within the last month;
- •Patients aged between 18 - 65 years;
- •Corneometer value < 35 a.u (on one volar forearm);
- •Skin type I-IV (Fitzpatrick et al. 1974);
- •Patients willing to adhere to trial procedures;
- •Patients willing to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in test areas 3 days before Day 1 and throughout the course of the trial;
- •Patients willing to stop smoking 2 hours before the instrumental measurements;
- •Patients willing not to drink caffeinated beverages 2 hours before the instrumental measurements;
- •Patients willing to avoid contact with water in the test areas 2 hours before the instrumental measurements;
- •Negative urine pregnancy test (for female patients of child bearing potential);
- •Women of child bearing potential have to use reliable methods of contraception with a low failure rate (i.e., less than 1 % per year; implants, injectables, combined oral contraceptives, hormone-based intrauterine-devices, sexual abstinence or vasectomized partner).
排除标准
- •Any other skin disease on the whole body that would interfere the clinical assessment in the opinion of the Investigator;
- •Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressive drugs and antihistamines) within 30 days before screening as well as during the trial (with exception of routine vaccinations);
- •Intrarectal or topical corticosteroids (in the test area) within 2 weeks before screening as well as during the trial;
- •Known allergies to any of the ingredients of the test product;
- •Any use of another topical emollient or other established treatment for atopic dermatitis in the test area;
- •Any other adjuvant therapy for atopic dermatitis (UV therapy, probiotics homeopathy etc.);
- •Patients with a Body Mass Index > 30;
- •Diabetes mellitus;
- •Patients who use tanning beds regularly within the past 2 years;
- •Exposure of the test area to the sun;
- •Pregnant or lactating women;
- •Moles, tattoos, pigmentation or scars on the forearms that would influence the instrumental measurements;
- •Hairy skin on test areas;
- •Patients with psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing;
- •Patients with any history of drug addiction or alcoholism in the past 3 years;
- •Patients with expected poor compliance;
- •Patients, who are inmates of psychiatric wards, prison or state institutions;
- •Participation in a clinical trial with investigational medicinal products or medical devices within the last 30 days prior to the start of this trial;
- •Patients underlying any other restrictions due to the participation in other tests / at other test institutes;
- •Employees of the trial sites or of the Sponsor's company;
- •Patients that according to the opinion of the Investigator should not participate in the trial for any reason.
研究组 & 干预措施
BAY987534 (Treated Arm)
Experimental
Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied.
干预措施: BAY987534 (Device)
Untreated Arm
No Intervention
Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied.
结局指标
主要结局
AUC of the skin hydration assessed of treatment with the test product compared to untreated
时间窗: Up to 4 weeks
AUC: Area under the curve
次要结局
- Transepidermal water loss(Up to 4 weeks)
- Number of participants with adverse events (AEs)(Up to 4 weeks)
- Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)(Up to 4 weeks)
- Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)(Up to 8 hours)
- AUC of the short term skin hydration(Day 1)
- Water gradient within stratum corneum assessed by Raman Spectrometry(Up to 8 hours)
- Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)(Up to 4 weeks)
- Skin pH(Up to 4 weeks)
- Compliance check(Day 29)
- Water content within stratum corneum assessed by Raman Spectrometry (unit: %)(Up to 8 hours)
研究者
研究点 (2)
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