A phase IIa, multi-center, randomized, double-blind study to evaluate the anti-mycotic and anti-inflammatory efficacy of topical combinational product LAS 41003 versus corresponding mono-substances in patients with candida infections in intertriginous areas at the trunk - Candida intertriginosa

Almirall Hermal GmbH0 个研究点开始时间: 2009年10月30日最近更新: 2012年7月31日

试验速览

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•All of the following criteria have to be met for inclusion of a patient in the study:
•men and women aged 18 years or over;
•presence of candida infections in one or more intertriginous areas at the trunk, confirmed by positive mycological sample at screening;
•physician’s global assessment score of 2 (notable signs and symptoms exist”) or 3 (prominent signs and symptoms exist”) at baseline;
•Erythema score =2 (moderate );
•the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
•patients must be willing and able to comply with the requirements of the trial protocol;
•written informed consent obtained.
•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

•Patients are to be excluded from the study when one or more of the following conditions are met:
•receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit;
•patients who have been treated with oral anti-fungal agents within the 12 weeks prior to the baseline visit or treated with topical anti-fungal agents on the intertrigines within the previous 2 weeks;
•evidence of drug or alcohol abuse;
•pregnancy or nursing;
•symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before the treatment phase and during the study;
•participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study;
•known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol;
•treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the treatment phase of the study (e.g. glucocorticosteroids);
•in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable non-compliance or inability to understand the study and give adequately informed consent;
•subject is institutionalized because of legal or regulatory order.

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