CTIS2022-501415-14-00招募中1 期
Double-blind, randomised clinical study comparing efficacy and safety of Mecloderm® Ointment (Test) vs. Lotricomb® Ointment (Reference) vs. Vehicle in patients with moderate to severely inflamed candidiasis of the skin - 21-01/ClotriBet-S
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 552
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Women and men = 18 years of age, Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team, 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 highly effective contraceptive method during the whole study, For women of childbearing potential: Pregnancy test with negative result prior to study start
排除标准
- •The treatment area exceeds 10% of the body surface, 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, 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, varicella), 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, suspected additional bacterial infection, Necessity of application of the study medication in the area around the eyes, Systemic treatment with antimycotics and/or glucocorticoids within the last 4 weeks prior to study inclusion, Known intolerance or hypersensitivity against clotrimazole or other imidazole antimycotics, betamethasone dipropionate or other glucocorticoids, 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
研究者
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