EUCTR2015-005707-92-DE进行中（未招募）1 期
Double-blind, randomised clinical study comparing efficacy and safety of Miconazole 2% Fluprednidene 0.1% Cream (Test) vs. Vobaderm® Cream (Reference) vs. Vehicle in patients with moderate to severely inflamed candidiasis of the skin.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
- •Women and men = 18 years of age
- •Written consent to study participation after patient information by the investigator
- •Diagnosis of candidiasis of the skin based on clinical symptoms
- •Positive mycological result of a swab revealing at least a moderate number of fungi, microscopically proven
- •Sum score of all clinical parameters (erythema, exudation, dysesthesia/ burning, maceration) = 7
- •At least moderate severity of inflammation parameters erythema and exudation (i.e. score value = 2)
- •For women of childbearing potential: Application of an efficient contraceptive method during the whole study
- •For women of childbearing potential: Pregnancy test with negative result prior to study start
- •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
- •The treatment area exceeds 10% of the body surface
- •Topical treatment in the observation area during the last 7 days prior to study inclusion
- •Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster), lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis, perioral dermatitis, acne, primary purulent skin infections (like e.g. folliculitis), atrophied skin, wounds, ulceration
- •Necessity of application of the study medication in the area around the eyes
- •Necessity of application of the study medication on mucous membranes
- •Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion
- •Known intolerance or hypersensitivity against miconazole (nitrate) or other imidazole antimycotics, fluprednidene 21-acetate, or any of the other ingredients in the study medications
- •Other severe acute or chronic concomitant disease with severe impairment of the general condition
- •Other concomitant diseases which may - taking the present knowledge into account - influence the • parameters evaluated in the study in a way that an objective evaluation would be impossible
- •Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
- •Reasonable doubt concerning the co-operation of the patient
- •Participation in another clinical study within the last 30 days prior to inclusion in this study
- •Participation in this study at an earlier date
- •Women with existing or intended pregnancy or during lactation
研究者
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