EUCTR2011-003295-37-LT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
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
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