A phase IIa single-center, randomized, controlled, observer-blind study to investigate the antimicrobial efficacy of topical formulations containing octenidine and prednicarbate in an expanded flora test with healthy subjects - Marples Kligman

Almirall Hermal GmbH0 个研究点目标入组 20 人开始时间: 2009年3月10日最近更新: 2020年3月30日

试验速览

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•All of the following criteria have to be met for inclusion of a subject in the study:
•men and women aged 18 to 45 years;
•healthy skin in the area of the test fields;
•the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•female volunteers 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.
•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) no
•F.1.3.1 Number of subjects for this age range

•Subjects are to be excluded from the study when one or more of the following conditions are met:
•acne, suntan, eczema, hyperpigmentation or tattoos in the test fields;
•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 and during the study;
•treatment with any other investigational drug in the four weeks preceding the 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 beginning of the study (e.g. antihistamines or glucocorticosteroids);
•contraindications according to summary of product characteristics;
•in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
•subject is institutionalized because of legal or regulatory order.

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