NCT07839897已完成不适用
EVALUATION OF THE EFFICACY AND TOLERANCE OF A FACE AND BODY EMOLLIENT CREAM IN SUBJECTS (INFANTS, CHILDREN, ADULTS) WITH MILD TO MODERATE ATOPIC DERMATITIS UNDER DERMATOLOGICAL CONTROL
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2025年5月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
研究概览
简要总结
The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control)
详细描述
This study is conducted as a single-center, open-labeled study in Latin America. A total of 59 subjects are enrolled in the study. Assessments are performed at Day 1, Day 8 and Day 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (no minimum required);
- •Age as presented below:
- •18-45 years old (n=20)
- •2-17 years old (n=15)
- •28 days to 23 months (n=15)
- •Phototypes IV-VI according to the Fitzpatrick scale following the distribution bellow:
- •Phototype IV: at least 2 by each age group
- •Phototypes V and VI: at least 75% by each age group and at least 2 by phototype
- •Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
- •Presenting atopic dermatitis with a SCORAD from 15 to 30
- •Subjects (18-45 years old) presenting at least one PIH and/or post inflammatory hypopigmentation induced by atopic dermatitis
- •Subjects who used the same cleansing product on face and body, the same make-up (if applicable), the same sunscreen product for at least two weeks before inclusion and remain stable during the whole study
排除标准
- 未提供
研究组 & 干预措施
Emollient treatment group
Experimental
All enrolled subjects (infants, children and adults) with atopic dermatitis and phototypes IV-VI (Fitzpatrick scale) receive the tested emollient cream applied once daily for 4 weeks.
干预措施: Emollient cream RV4660B (Other)
结局指标
主要结局
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
时间窗: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Evolution of the SCORAD assessed by the Investigator at each visit
次要结局
- Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)(Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29))
- Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)(Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29))
- Discomfort sensations(Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29))
- Dermatological tolerance of the tested product(Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29))
- Quality of life questionnaire(From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29))
- Atopic dermatitis disease control(From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29))
- Acceptability Questionnaire assessment(Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29))
- Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion(From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29))
- Extent of Dyschromic Areas(From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29))
研究者
研究点 (1)
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