EUCTR2014-002194-10-DE进行中（未招募）不适用
An intra-individual randomized controlled study to evaluate the efficacy and tolerance of the product RV4421A BS0042 in association with a moderately potent topical corticosteroid in adults with Atopic Dermatitis
Pierre Fabre Dermo-Cosmétique0 个研究点开始时间: 2014年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Criteria related to the population:
- •Patient male or female
- •Patient aged between 18 and 65 years included
- •Patient with phototype I, II, III or IV according to Fitzpatrick classification
- •Patient having signed his/her written informed consent for his/her participation in the study
- •Patient affiliated to a social security system or health insurance, or is a beneficiary
- •For women of childbearing potential :
- •ohaving been using an effective method of contraception (chirurgical or hormonal birth control or intrauterine device only) for at least 2 months before inclusion in the study,
- •oaccepting to go on using it during the whole duration of the study and up to 5 days after the last product application, in order to avoid pregnancy while being exposed to the study products
- •onegative urine pregnancy test
- •Criteria related to the disease:
- •Patient with a diagnosis of Atopic Dermatitis for at least one year
- •Patient with moderate to severe Atopic Dermatitis lesions symmetrical in terms of severity on both arms or on both popliteal fossa, whose scores index severity are as follows:
- •oL-IGA = 3 or 4 (moderate or severe) assessed on a scale ranged from 0 to 5
- •oL-SCORAD = 6 assessed on a 18-point scale with:
- •?xerosis score = 2 (moderate) on a scale ranged from 0 to 3
- •ono difference by more than 1 score point between each component of the L-SCORAD of both arms or of both popliteal fossa
- •ono more than 3 points of difference in the total L-SCORAD
- •Patient with Atopic Dermatitis lesions symmetrical in terms of extent on both arms or on both popliteal fossa: target lesions with a similar size on both arms or on both popliteal fossa, according to the judgement of the investigator
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Criteria related to the population:
- •Patient unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing to participate
- •Patient unable to understand the study procedures (for linguistic or psychiatric reasons) and to report required information in writing in his/her diary
- •Patient who has forfeited his/her freedom by administrative or legal award or under guardianship
- •Patient who is currently participating or who has participated in another clinical study within 1 month prior to inclusion visit
- •Patient who, in the judgement of the investigator, is not likely to be compliant during the study
- •For women: patient pregnant or breastfeeding
- •Criteria related to the disease
- •Skin disease on the study arms or legs other than AD liable to interfere with the assessment
- •Primary bacterial, viral, fungal or parasitic infections on the application areas
- •Ulcerated lesions on the application areas
- •History of disease considered by the investigator hazardous for the patient or incompatible with the study
- •On-going allergen reintroduction
- •On-going reintroduction diet within the framework of avoidance regimen (food allergy(ies))
- •Reintroduction diet
- •History of hypersensitivity or intolerance to any component of the test product and/or associated product’ ingredients
- •Criteria related to treatments and products
- •Phototherapy for less than 4 weeks prior to inclusion or required during the study
- •Systemic immunosuppressive treatment within 4 weeks before the inclusion or required during the study
- •Systemic corticosteroids within 2 weeks before the inclusion or required during the study
- •Systemic antihistaminic established or modified within 2 weeks before the inclusion
- •Systemic antibiotics within 1 week before the inclusion or required during the study
- •Topical immunomodulators (TIMs), non-steroidal anti-inflammatory, corticosteroids, antihistaminics, antibiotics or antiseptics treatments applied on study arm(s) or leg(s) within 5 days before the inclusion or required during the study
- •Skin care product (including moisturizer) applied on study arm(s) or popliteal fossa within 2 days before the inclusion visit
- •Water or any cleansing product, applied on study arm(s) or popliteal fossa 4 hours before the inclusion visit
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