Evaluation of the Efficacy and Tolerance of TOPIALYSE Baume Protect+ Vs Neutral Product on Patients Suffering from Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SVR Group
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Evaluation of the evolution of the symptoms associated with mild atopic dermatitis by the mEASI score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of a SVR care product.
As we know, atopic dermatitis is a vicious circle that must be broken, but certain aggravating factors are added to this circle. There is a lot of talk about pollution but, more recently, studies have been carried out on the worsening role of dust mites on atopic skin.
TOPIALYSE Baume Protect+ is a care product that is lipid-replenishing, repairing and protective: a triple reinforced action for 48 hours: anti-scratching, anti-irritation, and external anti-aggression. It is also intended for the whole family from birth for dry skin with an atopic tendency (with atopic eczema).
The main objective of this study is to evaluate the efficacy of the cosmetic product SVR TOPIALYSE Baume Protect+ versus Neutral Product on patients with mild atopic dermatitis, after 4 weeks of use with evaluation of the evolution mEASI (modified Eczema Area and Severity Index)
详细描述
- RATIONALE : The purpose of this study is to evaluate the efficacy and tolerability of a SVR care product.
As we know, atopic dermatitis is a vicious circle that must be broken, but certain aggravating factors are added to this circle. There is a lot of talk about pollution but, more recently, studies have been carried out on the worsening role of dust mites on atopic skin.
The new SVR product, TOPIALYSE Baume Protect+ will therefore be based on it.
TOPIALYSE Baume Protect+ is a care product that is lipid-replenishing, repairing and protective: a triple reinforced action for 48 hours: anti-scratching, anti-irritation, and external anti-aggression. It is also intended for the whole family from birth for dry skin with an atopic tendency (with atopic eczema).
2 STUDY OBJECTIVES 2.1 PRIMARY OBJECTIVE: The main objective of this study is to evaluate the efficacy of the cosmetic product SVR TOPIALYSE Baume Protect+ versus Neutral Product on patients with mild atopic dermatitis, after 4 weeks of use with evaluation of the evolution mEASI (modified Eczema Area and Severity index ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The randomisation will be done on the side of the treatment.
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer aged between 3 months and 18 years
- •Female or male volunteer
- •Volunteer with an atopic background and localized and symmetrical right/left signs of mild atopic dermatitis on the face and/or body: On the whole body: 0.1 < EASI < 7 [2] or
- •Localized - mEASI (cf. Appendix n°1):
- •On the arms: 0.02 < mEASI < 1.4
- •On the legs: 0.04 < mEASI < 2.8 (0.03 < mEASI < 2.1 for children under 8 years old)
- •On the trunk: 0.03 < mEASI < 2.1
- •On the head/neck: 0.01 < mEASI < 0.7 (0.02 < mEASI < 1.4 for children under 8 years old)
- •Volunteer agreeing not to use any other skincare product on the face or body for the duration of the study, except for study products,
- •Volunteer agreeing not to perform any corticosteroid or immunosuppressive treatment, per os or topical for the duration of the study,
- •Volunteer whose parent(s) or legal guardian(s) have given written consent to participate in the study,
- •Volunteer related to the social security of a parent or legal guardian in accordance with the French law on interventional research
排除标准
- •Volunteer with a history of allergy or hypersensitivity reaction to a cosmetic or any of the constituents of the test products.
- •Volunteer who received topical corticosteroid or immunosuppressive treatments during the week prior to study entry and during the study.
- •Volunteer who received oral corticosteroids during the month prior to study entry.
- •Presence of dermatosis, skin pathology or systemic disease that, in the opinion of the investigator, may interfere with the evaluation of the study parameters.
- •Existence of a systemic or local treatment which, in the opinion of the investigator, may interfere with the evaluation of the parameters studied.
- •Volunteer participating in another study or being in an exclusion period from a previous study.
结局指标
主要结局
Evaluation of the evolution of the symptoms associated with mild atopic dermatitis by the mEASI score
时间窗: DAY 0 and DAY 28±3
At D0 and D28±3, the dermatologist calculates the mEASI (modified Eczema Area and Severity Index) over the entire body, for that he have to select the affected area ( head and neck, upper extremities, trunk, lower extremities). For each zone, the investigator assesses the severity of the 4 signs of atopic dermatitis (erythema, oedema/papulation, excoriation, lichenification) from 0 ( none) to 3 (severe) on the selected area, he assesse the extent of atopic dermatitis in that area from 0 (none) to 6 (100% area of the body).
次要结局
- Analysis of the subject's answers to a subjective product evaluation questionnaire(DAY 0 and DAY 28±3)
- Evaluation of children's quality of life by IDQOL(DAY 0 and DAY 28±3)
- Evaluation of pruritus by VAS(DAY 0 and DAY 28±3)
- General safety: General Adverse Events will be reported descriptively on an on-going basis(DAY 0 and DAY 28±3)
- Evaluation of the tolerance of TOPIALYSE Baume Protect+ versus Neutral Product.(DAY 28±3)