Determination of the Thickness Truly Applied of the SPRAY50+ on Different Areas of the Face Estimated by a Multispectral Imaging Method, After Application of the Product With and Without Recommendations of Use by a Group of Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject
研究概览
简要总结
The aim of the study is to determine:
- the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
- the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
- the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .
详细描述
This study is a monocentric, comparative, open study performed on the face and forearms of healthy adults.
Planning of the visits:
Visit 1: Inclusion visit (D1) Visit 2: End of study visit (D10), a window of +/- 2 days is allowed for this evaluation, * The theoretical study duration for each subject is 10 days. The maximal study duration for each subject is 12 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry, normal to combination skin
- •Phototype I to V inclusive.
- •Absence of significant facial hair.
排除标准
- •Pregnant, breastfeeding women.
- •For men: moustached or bearded.
- •Substantial hair on the forearm and face.
- •Application of keratolytic or self-tanning products to the face, forearms and arms in the four weeks prior to inclusion.
- •With scars or other cutaneous characteristics, sunburn on forearms in the test areas, the size of which is considered incompatible with the study.
- •Application of water, cleansing or beauty products to the forearms and arms since the last wash on the evening before inclusion.
- •Known history of allergy to any of the investigational product ingredients.
- •Known history of allergy to latex.
- •Skin lesions or skin disease on the face or on the arms and forearms that may affect test results (seborrheic dermatitis, atopic dermatitis, psoriasis, acne, rosacea, etc.).
- •Treatments:
- •Ongoing local or Oral treatment (retinoids, anti-inflammatory) that may affect test results.
结局指标
主要结局
Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject
时间窗: Visit 1 (Day 1)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Amounts of sun spray applied to the face, measured by multispectral imaging after 1 application by the subject and according to the recommendations of use provided by the technician
时间窗: Visit 2 (Day 10)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject
时间窗: Visit 1 (Day 1)
The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique
Comparisons between measurements of sun spray amounts determined by multispectral imaging
时间窗: Visit 1 (Day1) and visit 2 (Day 10)
Comparaisons between an application without recommendations of use (Visit 1), an application without recommendations followed by a second application (Visit 1) and an application according to the recommendations of use (Visit 2)
次要结局
未报告次要终点