EUCTR2011-003295-37-EE进行中（未招募）不适用
Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extension
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
- 232
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 6 years included,
- •- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
- •- With xerosis on the body and a xerosis score > 2 (SCORAD sub-score) on the anterior part of lower limbs,
- •- Whose objective SCORAD score is < 15 at inclusion,
- •- Associated signs such as hyperlinearity in the palms and/or scales on the lower limbs,
- •- Whose parent(s) or guardian(s) has 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,
- •- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 232
- •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 moderate/severe erythema, mild/moderate/sever excoriation, crust, oozing or 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 skin infection,
- •- Ulcerated lesions, acne or rosacea,
- •- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- •- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics,
- •- Immunosuppression,
- •- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
- •Criteria related to treatments
- •- Use of oral corticosteroids or immunosuppressants during the last 14 days,
- •- Use of topical corticosteroids, systemic or local antibiotics on the lesions during the last 7 days,
- •- Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
- •- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics).
- •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
Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extensioEUCTR2011-003295-37-PLPIERRE FABRE MEDICAMENT232
进行中（未招募）
不适用
Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extensioEUCTR2011-003295-37-LTPIERRE FABRE MEDICAMENT232
进行中（未招募）
1 期
Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extensioxerosis in children with atopic dermatitisMedDRA version: 14.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2011-003295-37-FRPIERRE FABRE MEDICAMENT232
已完成
3 期
Efficacy Emollient on Xerosis in Children With Atopic DermatitisAtopic DermatitisNCT01467362Pierre Fabre Medicament251
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