EUCTR2008-003485-25-IT进行中（未招募）不适用
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study. - ND
适应症
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
- 550
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 between 2 and 7 years, - Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party, - Whose IGA score is  1 at inclusion, - Whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child`s participation in the study, - Whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints, - If required by national regulations, registered with a social security or health insurance system.
- •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
- •* Criteria related to pathologies - Acute phase of atopic dermatitis with mild/moderate/severe erythema, excoriation, crust, oozing, exudation, - Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation, - Primary bacterial, viral, fungal or parasitic infectio, Ulcerated lesions, acne or rosacea, - Dermatological disease other than atopic dermatitis liable to interfere with the assessment, - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study, - Immunosuppression, - History of hypersensitivity or intolerance to one of the substances of content of the study drug or Locapred, or to cosmetics. * Criteria related to treatments - Use of oral corticosteroids or immunosuppressants during the last month, - Use of antibiotics or topical corticosteroids during the last week, - Use of non-steroid anti-inflammatory drugs or antihistamines during the last week, - Use of homeopathic treatment during the last 2 months, - Regular use of food supplements that could, in the opinion of the investigator, modify skin properties. * Criteria related to the population - Child with a brother or sister already included in this study, - Patient and/or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing, - Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship, - Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency, - Participation to another clinical trial or being in the exclusion period of another clinical trial.
研究者
相似试验
进行中（未招募）
不适用
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyEUCTR2008-003485-25-LVPierre Fabre Médicament550
进行中（未招募）
不适用
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyEUCTR2008-003485-25-LTPierre Fabre Médicament550
进行中（未招募）
1 期
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyChildren between 2 and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party and whose IGA score is < or = 1 at inclusion.MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitisEUCTR2008-003485-25-PLPierre Fabre Médicament550
进行中（未招募）
不适用
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyChildren between 2 and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party and whose IGA score is < or = 1 at inclusion.MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitisEUCTR2008-003485-25-DEPierre Fabre Médicament550
进行中（未招募）
不适用
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind studyChildren between 2 and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party and whose IGA score is < or = 1 at inclusion.MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitisEUCTR2008-003485-25-EEPierre Fabre Médicament550