An Exploratory, Comparative and Multicentric Study, to Evaluate the Effect of the RV3278A - ET0943 on the Host/Micro-organism Relationships in Acneic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Effect of the RV3278A on inflammatory and retentionnal lesions
研究概览
简要总结
The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Related to the population:
- •Subject aged between 12 to 25 years included
- •Related to diseases:
- •Subject having acne lesions on the face, with GEA (Global Acne Evaluation) score on the face is assessed as 2 (mild) or as 3 (moderate), on a scale ranged from 0 (clear- no lesion) to 5 (very severe)
- •Subject having at least 20 open-comedones of about 1 mm in diameter on the face and possibly extractable
- •Subject having a predominance of non-inflammatory acne lesions
排除标准
- •Related to diseases:
- •Subject having comedones only on the nose wings
- •Subject with any other dermatological disease than acne or skin characteristics (like scar, tatoo) on the face liable to interfere with the study according to the investigator's assessment
- •Subject with an acute or chronic disease, or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Severe form of acne (Acne conglobata, Acne fulminans or nodulokystic acne) or acneiform induced rashes according to the investigator's assessment
- •Clinical signs of a hormonal dysfunction or of a hyperandrogenism
- •Solar erythema on the face due to excessive UV exposur
- •Related to the treatments/products:
- •Any previous/concomitant treatment or product considered by the Investigator liable to interfere with the study data or incompatible with the study requirements or hazardous for the subject
结局指标
主要结局
Effect of the RV3278A on inflammatory and retentionnal lesions
时间窗: Change from baseline to 2 months
Quantification of inflammatory and retentionnal lesions from image analysis
Effect of the RV3278A on metabolites
时间窗: Change from baseline to 1 month
Metagenomic analysis on comedones samples
Effect of the RV3278A on acne severity
时间窗: Change from baseline to 2 months
Global Evaluation Acne (GEA), on a 6-point scale 0: Clear. No lesions 1. Almost clear, Almost no lesions 2. Mild 3. Moderate 4. Severe 5. Very severe
Effect of the RV3278A on microorganisms
时间窗: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
Effect of the RV3278A on lipids
时间窗: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
RV3278A product tolerance
时间窗: From Day 1 to 2 months
Adverse events occurrence will be determined by the subject's / parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning, and his/her clinical evaluation
Effect of the RV3278A on hyperkeratosis
时间窗: Change from baseline to 2 months
Qualitative analysis by 2 and 3-dimensional electron microscopy from comedones samples
次要结局
未报告次要终点