Clinical Study for the Evaluation and Comparison of Cutaneous Acceptability and the Efficacy of 2 Cosmetic Products, Under Normal Conditions of Use, in Adult Participants With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioGaia AB
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
研究概览
简要总结
The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis.
It is carried out on cosmetic products, with the aim to further confirm safety of these products
详细描述
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics.
Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification.
Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids
- •Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index >25)
- •Participant presenting with a current lesion of Atopic Dermatitis on defined area
排除标准
- •Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study
- •Participant having background of intolerance or allergy
- •Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects
- •Participant having skin exposed to sunlight within 2 weeks preceding the inclusion
- •Participant having modified his/her cosmetic habits during the last two weeks
结局指标
主要结局
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
时间窗: 4 weeks
Cutaneous acceptability is assessed on the basis of clinical examination of the skin for physical signs (erythema, oedema, dryness) linked to the use of the investigational product and also evaluation the functional signs (prickling, tightness, heating)
次要结局
- Change in Local SCORAD index(baseline, at 4, and 8 weeks)
- Change in SCORAD index over 8 week period(baseline, at 4 and 8 weeks)