EUCTR2005-004259-37-DE进行中（未招募）不适用
An uncontrolled, multicenter 12 month long term study on skin reconstitution with Elidel® (pimecrolimus) 1% cream in adult patients with atopic eczema and corticosteroid induced skin damage - REPIDE
ovartis Pharma GmbH0 个研究点目标入组 40 人开始时间: 2006年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •age 18-60 years
- •clinically diagnosed atopic dermatitis according to Hanifin and Rajka
- •local IGA (target lesions face and cubital areas): 1-3
- •clinically (naked eye) evident skin atrophy due to long term topical steroid use
- •Dermatophot® Score (DPS) of 4-6 on at least two target areas
- •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
- •who are in an acute major flare condition
- •who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks prior to study entry
- •who were treated with topical therapy [e.g. topical steroids, tar, pimecrolimus 1% cream, tacrolimus (Protopic®)] known or suspected to have an effect on AD within 7 days prior to study entry or who have received systemic corticosteroids (i.e., oral, intravenous, intraarticular, rectal) within 4 weeks prior to study entry. Patients on a stable maintenance dose of inhaled corticosteroids may participate
- •who present with clinical conditions other than AD that according to investigator can interfere with the Dermatophot? evaluation (e.g., generalized erythroderma such as the genetic condition Netherton’s syndrome, other skin conditions such as psoriasis)
- •History of malignancy of any organ system, treated or untreated whether or not there is evidence of local recurrence or metastases
- •Systemic immunosuppression
- •Clinical signs of infection in the treatment area
- •History of hypersensitivity to pimecrolimus 1% cream or prednicarbate or to drugs with similar chemical structures and/or to any other ingredients of the formulation
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Females of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, IUDs, but also abstinence at the discretion of the investigator
- •Use of other investigational drugs within 30 days of enrollment
研究者
相似试验
进行中（未招募）
1 期
A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients - CERTES02Renal TransplantMedDRA version: M15Classification code 10023438EUCTR2005-000380-26-ESovartis Farmacéutica S.A.
进行中（未招募）
不适用
A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.Idiopathic Parkinson’s disease and end-of-dose wearing off.MedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's diseaseEUCTR2007-003134-42-DEovartis Pharma Services AG20
已完成
不适用
Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after single level Lumbar Disc ArthoplastyDegenerative Disc Disease of the Lumbar SpineMusculoskeletal - Other muscular and skeletal disordersACTRN12608000394347Stryker South Pacific50
进行中（未招募）
不适用
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational PeriodEUCTR2007-004951-12-CZAstraZeneca AB168
进行中（未招募）
不适用
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational PeriodType 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusEUCTR2007-004951-12-HUAstraZeneca AB168