EUCTR2018-001743-31-DE进行中（未招募）1 期
Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cutaneous emulsion (Test) vs. Advantan Milk 0.1% Cutaneous emulsion (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •Women, men and children/adolescents of both sexes = 6 years of age
- •Written consent to study participation after patient information by the investigator
- •In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator
- •Acute flare of atopic dermatitis according to the investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate)
- •Affected body surface (BSA) between at least 10% and not more than 40%
- •For women of childbearing potential : Application of an efficient contraceptive method during the whole study
- •For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •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
- •Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion
- •Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 7 days prior to study inclusion
- •Presence of tuberculous or syphilitic processes in the treatment area
- •Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated.
- •Presence of bacterial and mycotic skin diseases in the treatment area
- •Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication
- •Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations
- •Severe acute or chronic concomitant disease with severe impairment of the general condition
- •Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
- •Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
- •Reasonable doubt concerning the co-operation of the patient
- •Participation in another clinical study within the last 30 days prior to inclusion in this study
- •Participation in this study at an earlier date
- •Women with existing or intended pregnancy or during lactation
研究者
相似试验
进行中（未招募）
1 期
Clincal study to compare the therapeutic effects of two ointments with active substances betamethasone dipropionate and salicylic acid and of one ointment without active substance for patients with chronic stable plaque psoriasisEUCTR2020-004081-19-DEDermapharm AG306
进行中（未招募）
1 期
Clinical study to compare the therapeutic effects of two ointments with the active substances clotrimazole and betamethasone dipropionate and of one ointment without active substance for patients with moderate to severely inflamed infection of the skin through yeast fungi.moderate to severely inflamed candidiasis of the skinMedDRA version: 20.0Level: LLTClassification code 10007159Term: Candidiasis of skin and nailsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-003790-65-DEDermapharm AG552
进行中（未招募）
1 期
Clinical study to compare the therapeutic effects of two creams with the active substances miconazole and fluprednidene and of one cream without active substance for patients with moderate to severely inflamed infection of the skin through yeast fungi.moderate to severely inflamed candidiasis of the skinMedDRA version: 19.0Level: LLTClassification code 10007159Term: Candidiasis of skin and nailsSystem Organ Class: 100000004862EUCTR2015-005707-92-DEDermapharm AG340
进行中（未招募）
1 期
Clinical study to compare two creams with the active substance imiquimod and one cream without active substance for patients with actinic keratosisActinic keratosisMedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2016-000712-15-DEDermapharm AG426
进行中（未招募）
1 期
Clinical study to compare two gels with the active substance calcipotriol and betamethasone and one gel without active substance for patients with scalp psoriasisPsoriasis capitisMedDRA version: 20.0Level: LLTClassification code 10037157Term: Psoriasis of scalpSystem Organ Class: 100000018190EUCTR2016-001106-42-DEDermapharm AG225