2022-501415-14-00招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 552
- 试验地点
- 9
- 主要终点
- Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).
研究概览
简要总结
Assessment of efficacy and safety of a new ointment with clotrimazole (10 mg/g) and betamethasone dipropionate (0.64 mg/g) (Mecloderm®) in comparison with the authorised medicinal product Lotricomb® Ointment and the underlying vehicle of Mecloderm® in patients with moderately to severely inflamed candidiasis of the skin.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).
Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT visit 3 after 14 days).
次要结局
- Change of the sum score of clinical parameters between baseline and follow-up visits, and between main examination (EOT) and final examination
- Evaluation of overall therapeutic success by the investigator at the final examination
- Number (percentage) of patients with mycological success (negative mycological cultivation and/or negative microscopical result) at visit 3 (EOT) and at the final visit (visit 4)
- Evaluation of therapeutic success at visit 2 and EOT by the investigator and by the patient
- Number (percentage) of patients with clinical relapse/re-infection at the final examination visit
研究者
Department of Clinical Research
Scientific
Dermapharm AG
研究点 (9)
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