Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- change in the composite score
研究概览
简要总结
Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions.
The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.
详细描述
The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).
Regarding the statistical analysis, two different analysis are performed:
- Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage.
- Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.
A significant level of p <0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The creams are packaged in white tubes with specific labelling that does not allow to identify them. The 5% benzoyl peroxide tubes are delivered in commercial form.
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acneic facial skin
- •between 20 and 50 non-inflammatory lesions on the face
- •between 10 and 40 superficial inflammatory lesions on the face
- •no local acneic treatment in the previous 15 days
- •no treatment with isotretinoin in the previous 3 months
- •agreeing to apply only the study products
排除标准
- •less than 20 or more than 50 non-inflammatory lesions on the face
- •less than 10 or more than 40 superficial inflammatory lesions on the face
- •prescription of a local acne treatment for less than 15 days
- •prescription of an antibiotic treatment for less than 1 month
- •prescription of an isotretinoin treatment for less than 3 months
- •changing toiletries and hygiene products regularly
结局指标
主要结局
change in the composite score
时间窗: from baseline to month 6
the investigator evaluates i) the skin sensitivity (erythema, desquamation) and ii) the global tolerance on a 4-point scale (i) from Absent to Important and ii) from Nil to Excellent)
次要结局
- change in the lesion count(from baseline to month 6)
- change in the evaluation of global tolerance by the patient(from baseline to month 6)
- change in the evaluation of the efficacy by the investigator and patient(from baseline to month 6)
- change in the quality of life(from baseline to month 6)
- change in the evaluation of the global efficacy by the investigator(from baseline to month 6)
- change in the evaluation of skin sensitivity by the patient(from baseline to month 6)