EUCTR2007-002133-36-DE进行中（未招募）不适用
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1.Fully informed written consent of the legal representative and assent of the patient
- •2.Mild to moderate atopic dermatitis according to the Investigator’s Global Assessment (IGA 3 or 4)
- •3.History of atopic dermatitis for at least one year
- •4.Age of 2 – 17 years at baseline
- •5.Affected Body Surface Area (BSA): minimum of 5%
- •6.Patients in whom a treatment with topical corticosteroids is not recommended or is not possible, i.e. due to intolerability of topical corticosteroids, due to lack of efficacy of topical corticosteroids, due to use in the face and the neck where the use of topical corticosteroids is not recommended.
- •7.Wash out periods to be observed before start of study medication:
- •At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •At last 4 weeks have passed since any vaccination
- •At least 4 weeks have passed since local AD therapy using tacrolimus or pimecrolimus
- •At least 2 weeks have passed since antihistaminic therapy, unless taken regularly during the previous year
- •At least 2 weeks have passed since local AD therapy using corticosteroids
- •8.At least 4 weeks have passed since participation in an investigational drug study
- •9.Willingness to follow all study procedures
- •10.Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1.Pregnancy (in patients with childbearing potential), breast feeding
- •2.Indication for systemic therapy of the atopic dermatitis
- •3.Known sensitivity to Zarzenda®, and / or to any excipients of the formulation and/or to an extract of the nut butyrospermum parkii (shea)
- •4.Known sensitivity to macrolides
- •5.Lymphadenopathy
- •6.Known immune deficiency
- •7.Known hepatic insufficiency
- •8.Known renal insufficiency
- •9.Patients with severe excoriations
- •10.Patients with clinically active skin infection (e.g. acute and severe impetigo contagiosa)
- •11.Acute herpes simplex, mononucleosis, or mollusca contagiosa infection
- •12.Severe other viral, bacterial, or fungal skin infection (chicken pox, tinea corporis)
- •13.Acute infestations (e.g. head lice, scabies)
- •14.Generalized erythroderma, Netherton’s syndrome,
- •15.Any conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- •16.Patient is a dependent person, e.g., a relative / family member of the investigator and / or is a member of the investigator’s staff
研究者
相似试验
进行中（未招募）
1 期
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.Estudio clínico multicéntrico, aleatorizado y en doble ciego para examinar la eficacia y la seguridad de Zarzenda® en comparación con Elidel® en el tratamiento de la dermatitis atópica leve a moderada en niños y adolescentes.EUCTR2007-002133-36-ESINTENDIS GmbH80
进行中（未招募）
不适用
A multicenter, randomised, double-blind clinical study to examine the efficacy and safety of ZARZENDA in comparison to Elidel in the management of mild to moderate Atopic Dermatitis in children and adolescents. - NDEUCTR2007-002133-36-ITINTENDIS GMBH60
招募中
不适用
Clinical trial to evaluate the efficacy and safety of GUGUTAMS capsuleDiseases of The genitoruinary systemKCT0002940Kangdong Sacred Heart Hospital404
进行中（未招募）
1 期
Clinical trial to assess the efficacy and safety of Montelukast in patients with erosive / inflammatory arthrosis of the handsErosive / inflammatory arthrosis of the handsMedDRA version: 20.0Level: LLTClassification code 10003416Term: ArthrosisSystem Organ Class: 100000004859EUCTR2021-001465-20-ESaboratorios Farmalíder S.A.280
进行中（未招募）
不适用
A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd) versus placebo in patients with type 2 diabetes and moderate or severe renal insufficiencyEUCTR2007-003723-21-DEovartis Pharma Services AG525