EUCTR2008-004326-16-DE进行中（未招募）不适用
A prospective placebo-controlled intraindividual dose-finding study of Mometasone furoate cutaneous spray (solution) in patients with contact allergies
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Female or male subjects ? 18 years and ? 75 years of age in good general health
- •Individuals with a documented at least twofold positive (‘++’) patch reaction to one of the standard allergens in a patch test performed according to the guideline of the Deutsche Kontaktallergie Gruppe (DKG) version 05/2007 (http://www.uni-duesseldorf.de/awmf/ll/013-018.htm) in the last two years
- •Individuals who are willing and able to provide informed consent
- •Individuals who are willing and able to follow the requirements for study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast-feeding woman
- •Woman of child-bearing potential who plan to become pregnant or breast-feed
- •Subjects with known inflammatory and/or infectious skin diseases in particular individuals with skin conditions that, in the opinion of the investigator, are likely to increase the risk of unwanted side effects or complicate the assessments required according to the study protocol
- •Individuals with autoimmune and chronic inflammatory disorders including, but not limited to, lupus erythematosus, rheumatoid arthritis, HIV/AIDS, etc.
- •Individuals taking immunosuppressive drugs including, but not limited to, azathioprine, cyclosporine, tacrolimus, methotrexate, infliximab and other biologics
- •Individuals treated with corticosteroids systemically within 30 days prior to visit1
- •Individuals treated with antihistamines systemically within the last 10 days prior to visit1
- •Individuals receiving topical therapy in the test area within the last 14 days prior to visit1
- •Individuals with extensive UV-irradiation within the last six weeks prior to visit1
- •Individuals with known hypersensitivity to any ingredients contained in the products used for treatment of the patch test reactions according to the study protocol
- •Individuals who have participated in another clinical trial within the last 30 days prior to visit1
研究者
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