EUCTR2009-012194-35-DE进行中（未招募）不适用
A single-center, randomized, controlled, observer-blind, phase IV study to develop the atopic localized eczema regression test (ALERT) using marketed topical corticosteroid formulations of different strength and the calcineurin inhibitors pimecrolimus (Elidel®) in patients with a pre-disposition for atopic dermatitis - Atopic localized eczema regression test (ALERT)
bioskin GmbH0 个研究点开始时间: 2009年10月15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
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:
- •Men and women aged 18 to 55 years;
- •Fitzpatrick skin type II – III;
- •patients demonstrating irritative skin reaction to 24 h occluded epicutaneous test
- •with 1 % SLS, i.e. ‘responders’;
- •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;
- •the dermatological examination must be without relevant disease findings (except
- •the criteria for the Erlangen atopy score) unless the investigator considers an
- •abnormality to be irrelevant to the outcome of the study;
- •medical disposition for atopic dermatitis according to Erlangen atopy score sum
- •equal or higher than 10 points and no acute atopic dermatitis on the volar forearms
- •and no clinically relevant eczema on the body but otherwise no history of other
- •relevant dermatological or relevant systemic diseases;
- •medical history of atopic dermatitis;
- •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
- •Patients are to be excluded from the study when one or more of the following conditions are met:
- •Acne, suntan, skin infections, hyperpigmentation, or tattoos in the test fields;
- •patients with negative 24 ± 2 h occluded epicutaneous test with 1 % SLS
- •performed prior to at bioskin or during screening;
- •dark-skinned persons whose skin color prevents ready assessment of skin
- •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);
- •use of skin care products on the volar forearms within seven days before the ´
- •beginning of the induction phase;
- •symptoms of a clinically significant illness that may influence the outcome of the
- •study in the four weeks before and during the study;
- •significant UV-exposure 3 weeks prior to the start of the study including therapeutic
- •UV therapy and significant tanning of the volar forearm;
- •participation in the treatment phase of another clinical or cosmetic study within the
- •last four weeks prior to induction phase;
- •known allergic reactions to components of the study preparations (e.g. ´
- •hypersensitivity against cetylstearyl alcohol, propylene glycol, chlorocresol);
- •contraindications according to summary of product characteristics; (e.g. illnesses
- •associated with disorder of the pituitary-adrenal axis);
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •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
进行中（未招募）
不适用
A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate The Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery with General Anesthesia.Adjunct to anesthesia to facilitate tracheal intubation (non-depolarizing neuromuscular blocking agent)EUCTR2004-004728-11-DEAvera Pharmaceuticals Inc.230
进行中（未招募）
1 期
A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate The Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery with General Anesthesia.Adjunct to anesthesia to facilitate tracheal intubation (non-depolarizing neuromuscular blocking agent)EUCTR2004-004728-11-GBAvera Pharmaceuticals Inc.250
进行中（未招募）
不适用
A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate The Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery with General Anesthesia.Adjunct to anesthesia to facilitate tracheal intubation (non-depolarizing neuromuscular blocking agent)EUCTR2004-004728-11-DKAvera Pharmaceuticals Inc.250
已完成
不适用
Comparison of two devices for breathing support in newborn babiesPremature birthTransient tachypnea of the newbornACTRN12619000535178Fisher & Paykel Healthcare10
进行中（未招募）
不适用
Effectiveness and safety of Xen2174 in controlling pain after bunion surgeryModerate to severe acute post-operative pain in subjects following primary unilateral first metatarsal bunionectomyMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2010-019109-40-BGXenome Ltd150