Evaluation of the Efficacy and Tolerance of Topialyse Baume Barriere in Children With Atopic Dermatitis: Randomised, Multicentric, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- SVR Group
- 主要终点
- Evaluation of the topical corticosteroid consumption with the use of Topialyse Baume Barrière (1month)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of a new SVR care product and to evaluate the reduction of the topical corticosteroids' consumption with this emollient care.
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 SVR product is therefore based on it:
TOPIALYSE Baume Barrière is a care product that is lipid-replenishing, repairing and protective: a triple reinforced action for 48 hours: anti-scratching, anti-irritation, and anti-external aggression.
详细描述
- RATIONALE
The mainstay of treatment for Atopic dermatitis (AD) is use of emollient and topical medications. Topical corticosteroids are the gold standard of anti-inflammatory therapy in AD especially AD flare-ups, in order to reduce inflammation and pruritus. Their long-term use is associated with the risk of local and systemic adverse effects.
The purpose of this study is to evaluate the efficacy and tolerability of TOPIALYSE Baume Barrière and to evaluate the reduction of the topical corticosteroids' consumption with this emollient care.
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 Barrière on the reduction of topical corticosteroid consumption in children from 3 months to 17 years old presenting mild to moderate atopic dermatitis (5 < SCORAD < 40), after 28 days of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 3 months and 17 years old;
- •Female or male subjects;
- •Subjects of Caucasian origin with skin type I to IV according to the Fitzpatrick scale
- •Subject with atopic background and mild to moderate signs of atopic dermatitis on the face and/or the body - 5<SCORAD<40 [2] - with or without dust mite sensitivity;
- •Subject who had at least one atopic dermatitis flare-up in the month prior to the study;
- •Subject with dry to very dry skin on the face and the body;
- •Subject who used a topical corticosteroid - class 2 or 3 - during a flare-up in the month prior to the study;
- •Subject regularly using an emollient in the management of atopic dermatitis;
- •Subject agreeing not to expose to sunlight or artificial UV rays during the study period;
- •Subject who, in the Investigator's opinion, will comply with the requirements of the protocol (e.g., follow protocol instructions, have regular contact to allow evaluation during the study);
- •Subject agreeing not to use any other facial or body care product during the study period, except study products and their usual emollient;
- •Subject agreeing not to use any face or body care products 24 hours prior to the start of the study;
- •Subject agreeing not to use hygiene products with a moisturizing, nourishing, or anti-drying effect during the study period and at least 24 hours before the start of the study;
- •Subject agreeing not to carry out an oral corticosteroid treatment during the entire study period;
- •Patients whose legal guardian has given written consent for their participation in the study;
- •Subject related to the Social Security of a parent or legal guardian in agreement with the French law on interventional research.
排除标准
- •Subject has known or suspected allergies or sensitivities to any of the constituents of the test product (see Product labels);
- •Subject has a medical condition or is taking medication that could put him or her at undue risk;
- •Subject has an unstable medical condition or one that could interfere with the study;
- •Subject who has not received any topical corticosteroids in the month prior to the start of the study;
- •Subject who received oral corticosteroids during the three months before the start of the study;
- •Subject who received oral immunosuppressive drugs during the three months prior to the start of the study;
- •Subject who received local immunosuppressants during the month prior to the start of the study;
- •Subject who received antihistamines during the week prior to the start of the study;
- •Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator might interfere with the interpretation of the clinical trial results such as:
- •History of other recurrent dermatologic conditions (e.g., psoriasis, eczema, urticarial, and/or hives);
- •Any systemic, local disease or skin condition (i.e., active cutaneous diseases; scars, moles, excessive hair, non-flat area, sunburn, uneven skin coloration or other blemishes) on the body;
- •Subject is currently receiving treatment that may interfere, in the opinion of the Investigator, with interpretation of the study results;
- •Subjects taking part in another study or being excluded from a previous study.
结局指标
主要结局
Evaluation of the topical corticosteroid consumption with the use of Topialyse Baume Barrière (1month)
时间窗: DAY 28
Evaluation of the reduce of amount of topical corticosteroid by comparing the number of days of use and the weight of class 2 or 3 topical corticosteroid per month before and after the use of the cosmetic product (TOPIALYSE Baume Barrière)
次要结局
- Evaluation of the topical corticosteroid consumption with the use of Topialyse Baume Barrière (1month)(DAY 56)
- Evaluation of the effect of the product on the improvement of the quality of life of children(DAY 28 and DAY 56)
- Evaluation of the efficacy of the product by reducing the number of atopic dermatitis flare-ups(DAY 28 and DAY 56)
- Evaluation of the product's effectiveness by reduction of the mean PO-SCORAD (Patient Oriented Scoring of Atopic Dermatitis) per month(DAY 28, DAY 56, DAY 57 and DAY 58)
- Evaluation of the efficacy of the product on the skin condition by a dermatologist on a 5-point scale.(DAY 28 and DAY 56)
- Evaluation of the efficacy of the product on the cutaneous condition.(DAY 28, DAY 56, DAY 57 and DAY 58)
- Evaluation of the efficacy of the product by reducing the SCORAD (Scoring of Atopic Dermatitis)(DAY 28 and DAY 56)