EUCTR2006-001184-29-DE进行中（未招募）不适用
A controlled, randomized, evaluator-blinded study for the assessment of efficacy and safety of Imazol® Paste and Multilind® Heilsalbe in infants with diaper dermatitis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Clinical diagnosis of diaper dermatitis
- •2) Infants aged between 4 months and 2 years
- •3) Total symptom score (TSS5) of at least 5.
- •4) Current diaper dermatitis is present for less than 6 weeks.
- •5) Written informed consent of the parents or the legal representative
- •6) Outpatient status
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Chronic diaper dermatitis >6 weeks duration
- •2) Known or suspected hypersensitivity to the active ingredients or excipients of the investigational drugs
- •3) Topical or systemic immunosuppressive therapy (incl. corticosteroids) or congenital immunodeficiency
- •4) Concomitant skin diseases which could interfere with the assessment of diaper dermatitis, e.g. psoriasis, perianal streptococcal dermatitis, anogenital warts, allergic contact dermatitis
- •5) Treatment with one of the active ingredients of the study medication within the past 2 weeks
研究者
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