NCT07107854已完成不适用
EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE - USE TEST UNDER DERMATOLOGICAL CONTROL - MULTICENTER STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- comedogenic potential
研究概览
简要总结
EVALUATION OF THE EFFICACY OF COSMETIC PRODUCT IN ADULTS SUBJECTS WITH MILD TO MODERATE ACNE. USE TEST UNDER DERMATOLOGICAL CONTROL. THE STUDY CONDUCTED IN POLAND AND MAURITIUS
详细描述
Claims:
- Improvement of acne
- Improvement of skin smoothness parameters
Objectives:
To evaluate:
- Its capacity to maintain the human face in good condition (cutaneous acceptability) by clinical examination under dermatological control;
- their comedogenic potential by counting the retentional and inflammatory lesions by the dermatologist in charge of the study;
- its smoothing effect by collecting polymer silicone skin's prints Silflo® and analysis using 3D Primos® Compact System
- its capacity to improve skin elasticity using cutometer®
- its capacity to maintain skin hydration using corneometer®
- its effect on the skin state by clinical scoring by the dermatologist in charge of the study;
- its effect on skin state by clinical auto scoring by the subjects;
- their anti-acne effect by GEA score and AFAST (score B) by the dermatologist in charge of the study;
- to illustrate their visual expected effect using ColorFace® and skincam®;
- to evaluate the change of subjects' quality of life questionnaire (AI-ADL) from baseline to D84 and D168;
- subjectively its cosmetic acceptability, properties, efficacy and future use by analysis of the subjects' answers to a subjective evaluation questionnaire
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: female and male;
- •Age: 20 years old and above;
- •Type: Caucasian;
- •Phototype: I to VI
- •At least 10 subjects per phototype;
- •At least 5 subjects with GEA 3 per phototype;
- •At least 2 males per phototype
- •Subjects with mild to moderate acne (GEA 2-3);
- •Subjects with at least 8 inflammatory lesions (full face);
- •Subjects at least 20 non inflammatory lesions (full face). Healthy subject;
- •Subject having given her/his free informed, web written consent;
- •Subject willing to adhere to the protocol and study procedures.
排除标准
- •Concerns woman: Pregnant or nursing woman or woman planning to get pregnant during the study;
- •Cutaneous pathology on the studied zone other than acne (eczema etc.);
- •Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products (according to the investigator's appreciation);
- •Oral treatment of retinoids during the six previous months of the study;
- •Topical acne treatment since less than one month;
- •Acne with documented hormonal origin (e.g PCOS, hyperandrogenia of other origin).
- •Any change in hormonal treatment (including contraceptive) during the three previous months of the study or subject under Androcur®;
- •Subject under cyproterone-based or drospirenone medications (like Diane 35®, or Jasmine®, or Holgyème® or generic) treatments since less than six months;
- •Professional facial care during the previous month of the study;
- •Subject manipulating her acne lesions;
- •Subject with make-up on the day of the visit at the laboratory;
- •Excessive exposure to sunlight or UV-rays within the previous month;
- •Subject having undergone a surgery under general anesthesia within the previous month;
- •Subject enrolled in another clinical trial during the study period (concerns the studied zone);
- •Subject considered by the investigator to be likely not compliant to the protocol;
- •Subject enrolled in another clinical trial during the study period (concerns the studied zone);
- •Subject who does not meet the Ministry of Health guidelines for COVID-19 at time of the visit.
结局指标
主要结局
comedogenic potential
时间窗: kinetics: Day 0, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
comedogenic potential by counting the retentional and inflammatory lesions by the dermatologist in charge of the study;
次要结局
未报告次要终点
研究者
研究点 (1)
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