跳至主要内容
临床试验/NCT05483205
NCT05483205已完成不适用

Benefit of a Dermocosmetic in Mild to Moderate Adult Acne

Cosmetique Active International11 个研究点 分布在 11 个国家目标入组 2,827 人开始时间: 2019年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,827
试验地点
11
主要终点
Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

研究概览

简要总结

The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

详细描述

Acne is a chronic inflammatory condition, impacted by exposome factors. A dermocosmetic, Normaderm Phytosolution (NP), was developed to target hyperkeratosis, inflammation, and sebum, while protecting the skin barrier, and to be used either alone or in addition to acne medications. NP is a dermocosmetic specifically developed for acne-prone skin. The lightweight cream is easily absorbed and targets acne pathogenesis thanks to salicylic acid 2% for skin exfoliation, phyco-saccharide 2% for sebum reduction, and vitamin CG as anti-inflammatory ingredient, as well as ingredients that enable regeneration of the disrupted skin barrier, such as Vichy mineralizing water 60%, Bifida ferment lysate 1%, and hyaluronic acid 0.2%.

The study was 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).

Qualitative variables were described as numbers and percentages. 95% confidence intervals (CI) were calculated, where required. Quantitative variables were described as number, mean, standard deviation, median, minimum, maximum and number of missing data.

All statistical analyses were performed at a 5% significance using 2-sided tests, except normality, tested at the threshold of 1% (Shapiro-Wilk test).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men or women (age >18 years old) with mild to moderate acne (GEA scale 1-3).

排除标准

  • Patients taking isotretinoin. Patients presenting with highly inflammatory acne, grade 4 or 5 on the GEA scale. Patients presenting with nodules.

结局指标

主要结局

Benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

时间窗: 90-day use

Change in global acne severity using a scale from 0=none to 5 very severe (GEA scale)

次要结局

  • Change in seborrhea level(90-day use)
  • Change in skin hydration(90-day use)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验