Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in the seborrhea evaluation
研究概览
简要总结
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.
The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.
The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.
This product is expected:
- to leave the skin clean and smooth,
- to help unblock pores,
- to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
- to be non-comedogenic.
详细描述
The study is performed in the Centre de Pharmacologie Clinique Appliqué à la Dermatologie (CPCAD), authorized by the French Regional Agency of Health (ARS) to perform biomedical research (Site agreement n°: 2016-04).
This clinical trial protocol and all amendments will be reviewed and approved by an appropriate Independent Ethics Committee (IEC) (Comité de Protection des Personnes (CPP)) located in France. The clinical trial cannot start before CPP approval.
The clinical trial is conducted under the sponsorship of Sponsor in compliance with the applicable international and local regulatory requirements as well as applicable International Council on Harmonisation (ICH) guidelines and in accordance with the Standard Operating Procedures (SOPs) for clinical trial conduct and monitoring from the assigned monitor.
All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk).
Regarding the analysis of efficacy endpoints, quantitative parameters are analyzed using a linear mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point is compared to Baseline using a Dunes adjustment for multiplicity correction. For each fitted model, residual plots will be used to check the model assumptions. If there is an obvious deviation to these assumptions, the analysis is done on the rank-transformed data. Ordinal parameters (GEA) are analyzed using a cumulative link mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point will be compared to Baseline using a Dunnett adjustment for multiplicity correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female subjects aged 20 years or above
- •phototype II to IV
- •mandibular acne (with or without diffuse acne)
- •at baseline (Day0) a AFAST (Adult Female Acne Scoring Tool) score of 1 or 2 in the mandibular area and not over
- •15 non-inflammatory lesions and 5 inflammatory lesions minimum (screening and baseline)
- •microcomedones on the mandibular area (visible with Vivacube measurement),
排除标准
- •female subject pregnant or lactating or who intends to conceive a child during the clinical trial or within one month after the last clinical trial visit
- •facial acne without mandibular acne
- •still undergoing medical treatment for acne at baseline (D0)
- •intensively exposed to UV within the month preceding the baseline visit
- •history of any severe disease or current condition (based on subject's interview and/or results of screening physical examination) which, in the opinion of the Investigator would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results (e.g. cancer, immune disorders)
结局指标
主要结局
change in the seborrhea evaluation
时间窗: from baseline to Day84
assessment performed by the investigator by visual inspection (gloss and shine aspect), and recorded using a 0-3 grading scale
change in GEA (Global Evaluation Acne) score
时间窗: from baseline to Day84
evaluation of the acne grade by the investigator on a 6-point scale (from 0 Clear. No lesions to 5 Very severe)
change in Adult Female Acne Scoring Tool (AFAST) score
时间窗: from baseline to Day84
evaluation of the acne grade by the investigator on a 4-point scale
change in acne count
时间窗: from baseline to Day84
lesion count by the investigator: inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (opened/closed comedones) on full face
次要结局
- change in the quality of life(Day0, Day14, Day28, Day56, Day84)
- change in the sensitivity assessment by the investigator(from Day48 hours (phone call) to Day84)
- change in the sensitivity assessment by the participant(from Day48 hours (phone call) to Day84)
- change in subject's and Investigator's global assessment of efficacy(from Day7 to Day84)
- change in the quantity of sebum(from baseline to Day84)
- change in the global tolerance(from Day7 to Day84)