NCT05057351已完成不适用
Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo
Greenpharma S.A.S.2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
研究概览
简要总结
Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Good general health
- •Phototype I to IV
- •Mild to moderate SCORAD (between 15 and 25)
排除标准
- •Pregnant/breastfeeding female or who have planned a pregnancy during the study period
- •Positive history for atopy or hypersensitive skin
- •Subjects under systemically pharmacological treatment
- •Subjects under locally pharmacological treatment on the skin area monitored during the test
- •Subjects with congenital or acquired immunodeficiency
- •Subjects under treatment with food supplements which could interfere with the functionality of the product under study
- •Subjects which show other skin alterations on the monitored area except for acne lesions
- •Subjects with known or suspected sensitization to one or more test formulation ingredients
结局指标
主要结局
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
时间窗: 7, 14 and 28 days
次要结局
未报告次要终点
研究者
研究点 (2)
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