2025-521620-29-01招募中2 期
Efficacy and safety of two moisturising creams for maintenance treatment of atopic dermatitis compared to no treatment: A prospective, controlled, split-body study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Galenica AB
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- • Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
研究概览
简要总结
To demonstrate superiority in time to relapse of eczema with moisturisers Oviderm cream and Urea/propylene glycol cream, respectively, as compared to non-treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient has given their written consent to participate in the study
- •Age ≥ 18 years
- •Patients with known AD or diagnosed with AD according to the Williams criteria [1] with visible atopic lesions on arms and/or legs. Two lesions on left respective right side with a size of 2 x 2 cm to 10 x 10 cm should be available, i.e., study areas. The largest lesion should not be more than 50% larger than the smallest lesion in length and width, i.e., the length of the largest selected lesion ≤ 1.5× the length of the smallest and the width of the largest selected lesion ≤ 1.5× width of the smallest lesion
- •Moderate to severe form of AD, IGA ≥ 3 [2], a mEASI score on the defined study areas of ≥ 4 and with a difference between left study area to right study area of ≤ 1 and which, in the opinion of the Investigator, can achieve complete clearance with a class III corticosteroid treatment for approximately 4 weeks
排除标准
- •Eczema exclusively on the hands
- •Patients assessed by the Investigator to have mild atopic dermatitis
- •Patients treated for AD with systemic drugs, topical corticosteroids class IV and light treatment during the last 3 months
- •Any concomitant medications that, in the opinion of the Investigator, could affect the study outcome
- •Known sensitivity or allergy to any of the study products
- •Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments or procedures
- •Patients assessed by the Investigator to have poor compliance
- •Patients assessed by the Investigator to have difficulty reading and understanding the local language
- •Patients who are pregnant, breast feeding or planning to become pregnant during study participation
结局指标
主要结局
• Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
• Time to relapse of eczema (patient reported outcome [PRO]) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
次要结局
- • Time to relapse of eczema (PRO) on a defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first
- • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS)
- • Change in self-reported pruritus on defined study area from baseline until the eczema relapses or until the end of the maintenance phase, whichever comes first, using Peak Pruritus Numerical Rating Scale (NRS) per time
- • Frequency of adverse events during the maintenance phase
研究者
研究点 (9)
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