The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Facial skin elasticity
研究概览
简要总结
The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. .
详细描述
The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19.
The study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28).
- Screening visit: obtained Informed Consent, COVID-19 detection by swab RT-PCR, and inclusion and exclusion criteria, wash out product dispensing, and subject's diary dispensing.
- Baseline visit: Investigator will check vital signs, facial skin value by Cutometer, Mexameter, Sebumeter, Corneometer, Colorimeter, Tewameter, dan pH meter, and kin taping by Corneofix tape. Investigational Products will dispensed in this visit for 2 weeks usage.
- First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
- Second follow up: Investigator will check vital signs, facial skin value, and skin taping by Corneofix tape.
All adverse events (AEs) occurred during study will be recorded in Case Report Form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female 18-35 years old
- •signed the informed consent
排除标准
- •infected by COVID-19
- •females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy
- •females with ongoing skin treatments.
结局指标
主要结局
Facial skin elasticity
时间窗: 28 days
The ratio between pliability/firmness and expressed in mm. The result before and after product application will be observed by cutometer.
Skin color intensity
时间窗: 28 dyas
The skin color expressed in colorimeter index value. The observation is conducted before and after product application
Transepidermal Waterloss (g/h/m2)
时间窗: 28 days
The hydration of skin is observed by Tewameter. The observation is conducted before and after product application
Sebum unit of facial skin
时间窗: 28 days
Sebumeter unit (mcg/cm2) of facial skin before and after product application will be observed using sebumeter. This sebumeter unit reflects the concentration of sebum on skin per observed area.
Capacity of corneometer unit
时间窗: 28 days
Corneometer unit reflects the moist index of skin. The corneometer unit observed by Corneometer, before and after product application.
Microbiome diversity index
时间窗: 28 days
The amount and diversity of microbiota will be observed on facial skin before and after product application
pH of facial skin
时间窗: 28 days
The pH of facial skin is observed using skin-pH-meter. Observation is conducted before and after product application
The skin color related to the Minimal Erythema Dosage (MED)
时间窗: 28 Days
The skin color (MED) is observed using Mexameter and is conducted before and after product application
次要结局
未报告次要终点
研究者
Prof. dr. Franciscus D. Suyatna, PhD, SpFK
Clinical Pharmacology Professor
Indonesia University