EUCTR2008-005890-37-DE进行中（未招募）不适用
Assessment of the effects on barrier impairment, clinical features and bacterial colonization of topical formulations in patients with atopic eczema; a phase IIa, single-center, randomized, observer-blind study - Atopic eczema
Moberg Derma AB0 个研究点目标入组 30 人开始时间: 2008年10月20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
- 30
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 patient in the study:
- •signed written informed consent obtained;
- •male or female patients, 18 years or older;
- •manifest atopic eczema diagnosed according to Hanifin and Rajka;
- •two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting Hanifin and Rajka´s criteria);
- •TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas;
- •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the 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.
- •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
- •Patients are to be excluded from the study when one or more of the following conditions are met:
- •acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
- •suntan which in the opinion of the investigator prevents correct assessments
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •UV-therapy within 6 weeks before first treatment;
- •participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •known allergic reactions to components of the study preparation and the comparator;
- •treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
- •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 noncompliance or inability to understand the study and give adequately informed consent;
- •patient is institutionalized because of legal or regulatory order.
研究者
相似试验
已完成
1 期
Assessment of the Effects on Barrier Impairment, Clinical Features and Bacterial Colonization of Topical Formulations in Patients With Atopic Eczema; a Phase IIa, Single-center, Randomized, Observer-blind StudyAtopic DermatitisNCT00863005Moberg Pharma AB
已完成
不适用
ENVIRONMENTAL OBSTACLES AFFECTING THE AGEING PROCESS OF ELDERLY IN EAST SIKKIM,INDIACTRI/2018/03/012567FRIEDA BOKALI P ENGHEEPI450
尚未招募
Unknown
Impact of difficulties faced by allied health professionals while using and accessing Health Information SystemsCTRI/2024/04/065813Scamran Pinto
已完成
不适用
To identify the difficulties and its influence on the Quality of life in school going children with Cerebral PalsyCTRI/2020/12/029638Sancheti Institute College of Physiotherapy30
已完成
不适用
Verification of the effect of a novel barrier improving agentCongenital keratosis abnormalityJPRN-UMIN000028790Asahikawa Medical University8