EUCTR2009-014550-14-DE进行中（未招募）不适用
A single center, randomized, controlled study to determine the irritant potential of topical acne formulations on intact healthy skin on the back following repeated application during a 21-day treatment period - Cumulative irritiation test
Dow Pharmaceutical Sciences, Inc on behalf of Coria Laboratories0 个研究点目标入组 33 人开始时间: 2009年8月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
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
- •All of the following criteria have to be met for inclusion of a subject in the study:
- •men and women aged 18 years or older;
- •healthy skin on which reddening can be easily recognized 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 intrauterine 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are to be excluded from the study when one or more of the following conditions are met:
- •acne, suntan, sunburn, eczema, hyperpigmentation or tattoos in the test fields;
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •subjects with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before 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 and during the study;
- •known allergic reactions or hypersensitivity to any of the components of the study preparations or to lincomycin; known allergy to fish (one study preparation includes soluble fish protein);
- •treatment with antiperistaltic agents such as opiates and diphenoxylate with atropine within four weeks prior to the first administration of investigational drug in this study and during the study;
- •treatment with products containing clindamycin, erythromycin, lincomycin or chloramphenicol within four weeks prior to the first administration of investigational drug in this study and during the study;
- •treatment with neuromuscular blocking agents within four weeks prior to the first administration of investigational drug in this study and during the study;
- •known allergy to adhesive on the patches used for occlusion in this study;
- •treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study and during the study (e.g. antihistamines or glucocorticosteroids);
- •contraindications according to summary of product characteristics (SmPC) of the test products;
- •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 an employee or relative of an employee of the investigational site;
- •subject is institutionalized because of legal or regulatory order.
研究者
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