EUCTR2006-000582-11-DE进行中（未招募）不适用
Determination of anti-inflammatory efficacy of topical formulations in a UV erythema test - UV erythema
ALTANA Inc0 个研究点目标入组 20 人开始时间: 2006年5月4日最近更新:
适应症
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
- 20
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:
- •males or females, aged 18 to 50 years;
- •skin type I to III according to Fitzpatrick;
- •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;
- •non-tobacco using subjects for 30 days prior to start of study;
- •sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
- •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
排除标准
- •Subjects are to be excluded from the study when one or more of the following conditions are met:
- •acne, suntan, eczema, hyperpigmentation/hypopigmentation or tattoos in the test fields;
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions, skin type IV to VI according to Fitzpatrick;
- •light dermatosis or other hypersensitivity to UVA/B;
- •multiple dysplastic nevi;
- •allergy to Fixomull Stretch used in this study;
- •evidence of drug or alcohol abuse within previous 12 months;
- •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;
- •participation in another clinical trial involving UVB irradiation in the six months preceding the study;
- •known allergic reactions to components of the study preparations;
- •treatment with systemic or locally acting medications which might counter or influence the study aim within thirty days before the beginning of the study (e.g. antihistamines or glucocorticosteroids);
- •use of any concomitant medication with the exception of hormonal contraceptives, medications for regulation of thyroid function, or if necessary paracetamol;
- •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;
- •tobacco using subjects within 30 days prior to start of study;
- •receipt of any drug/device as part of a research study within 30 days prior to initial study dosing;
- •consumption on average of more than 500mg/day of caffeine per day prior to or during the study (i.e. in beverages).
研究者
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