A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 5
- 主要终点
- To study the compatibility of the skin with the new formulation in comparison to the reference medication.
研究概览
简要总结
Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.
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
- Triple (Participant, 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
- •Females and males between 18 and 65 years of age
- •Caucasian
- •AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back
- •No serious health conditions that may interfere with the study
- •Written informed consent
排除标准
- •Eczematous regions exclusively in intertriginous areas or in the face
- •Use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks
- •Use of oral steroids within 1 month prior to the study
- •Use of concurrent medication e.g. medication that may interfere with the study related activities
- •Factors suggesting low compliance with study procedures
- •Possible allergy to ingredients in the study medications
- •Pregnancy or breast feeding
研究组 & 干预措施
1:1
Part 1 - eczema treatment
干预措施: betamethasone valerate (Drug)
1:2
Part 1 - eczema treatment
干预措施: betamethasone valerate (Drug)
2:1
Part 2 - maintenance treatment
干预措施: urea (Drug)
结局指标
主要结局
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
时间窗: 3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
时间窗: Up to 6 months
次要结局
- To study cosmetic acceptance of the corticosteroids(3 weeks)
- To study the safety of corticosteroid treatment.(3 weeks)
- To study the safety of maintenance treatment.(Up to 6 months.)