EUCTR2013-000715-25-DE进行中（未招募）不适用
A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCort 1% cream versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCort 1% cream
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •men and women aged 18 years or older;
- •manifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitis;
- •two comparable lesional areas of at least 2 cm2, with the clinical condition of atopic eczema or seborrheic eczema or stasis dermatitis rated mild;
- •the lesions should be located contralaterally for patients with atopic eczema and stasis dermatitis;
- •an erythema score = 1 in both lesional areas;
- •the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
- •female patients 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;
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •acne, suntan, eczema other than atopic eczema, seborrheic eczema or stasis dermatitis massive hyper- or hypopigmentation or tattoos in the treatment areas;
- •syphilitic or tuberculous dermatitis, varicella or vaccine reactions;
- •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;
- •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial;
- •participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial;
- •known allergic reactions to components of the investigational product/s;
- •treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial, e.g. antihistamines, medication that influences liver function, or glucocorticosteroids (exception: asthma may be found in patients with atopic dermatitis, therefore inhalation with corticosteroids in patients with asthma accompanying atopic dermatitis will be allowed);
- •contraindications according to the summary of product characteristics of Soventol® HydroCort 0.5% and Linolacort® Hydro 1.0%;
- •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the clinical trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
- •close affiliation with the investigator (e.g. a close relative) or persons working at the trial centers or patient is an employee of sponsor;
- •patient is institutionalized because of legal or regulatory order.
研究者
相似试验
已完成
不适用
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Nebivolol/Rosuvastatin combination treatment in patients with concomitant Hypertension and HyperlipidemiaDiseases of the circulatory systemKCT0002148Elyson Pharmaceutical276
进行中（未招募）
1 期
A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCortisonACETAT 1 % Cremogel versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCortisonACETAT 1 % CremogelEUCTR2017-000984-34-DEMedice Arzneimittel Pütter GmbH & Co KG50
进行中（未招募）
1 期
This multicenter, randomized, double-blind, phase II study aims to show improvement in the rate of mucositis/stomatitis (WHO´s OTS) grade 2-4 at 12 weeks after start of treatment by comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema starting with a low dose over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.Advance Breast cancer under endocrine treatmentMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864EUCTR2014-005126-35-DEGBG Forschungs GmbH156
进行中（未招募）
不适用
Comparison of defined skin parameters in two comparable lesional skinareas after topical treatment with Soventol HydroCort 0.5 % Cremogel or Placebomanifest atopic dermatitis diagnosed according to Hanifin and Rajka, or seborrheic eczema or stasis dermatitisEUCTR2011-001175-38-DEMEDICE Arzneimittel Pütter GmbH & CO.KG
进行中（未招募）
1 期
A randomized, multi-centre, double-blind, phase II clinical trial of dose finding of Montelukast in patients with erosive osteoarthritis of the hands. HOME study.Erosive osteoarthritis of the handsCTIS2023-506137-30-00Farmalider S.A.50