Assessment of the Effect of the Product RV2666C Formula LA2984 Compared to an Untreated Area With an Epidermally Ablated Skin Model Obtained With an Erbium YAG Laser on Adults Presenting IV to VI Skin Phototype
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Time to complete wound healing
研究概览
简要总结
In this study, we assess the efficacy of a cosmetic product in adults with IV to VI skin phototype.
This study is conducted as a monocentric, controlled, compared with an untreated area and randomized for the area of product application.
To perform this clinical study, minimum 20 - maximum 24 subjects (man or woman), aged from 18 to 50 years are enrolled.
The subjects applied the investigational product on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included.
10 visits are planned:
- Visit 1: Inclusion visit = Day 1
- Visit 2 to Visit 5: Intermediate visits = Day 2 to Day 5
- Visit 6: Intermediate visit = Day 8
- Visit 7: Intermediate visit = Day 10
- Visit 8: Intermediate visit = Day 12
- Visit 9: Intermediate visit = Day 15
- Visit 10: End of study visit = Day 19-1
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman from 18 to 50 years old
- •Phototype IV to VI according to the Fitzpatrick classification
- •Subject smoking ≤ 10 cigarettes/day containing nicotine, paper or e-cigarette equivalent
- •Subject agreeing not to expose his forearms to UV (natural or artificial) throughout the duration of the study and up to 3 months after the end of participation in the study
- •Subject protected by a tetanus vaccination according to the vaccination schedule established by the Public Health Agency
- •Main non-inclusion criteria:
- •Subject suffering from a disease liable to affect the wound healing process according to the opinion of the investigator
- •Subject with a known history of allergy or contact dermatitis induced in particular by the latex, the plaster, the local anesthetic, the local antiseptic or one of the components of the study product
- •Subject with a disease including skin disease in progress on the upper limbs that may interfere with the interpretation of the evaluation criteria according to the opinion of the investigator
- •Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational product according to the investigator's assessment
排除标准
- 未提供
结局指标
主要结局
Time to complete wound healing
时间窗: Day 1 - Visit 1, Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The wound disappearance is assessed by the investigator by clinical exam of the skin and from standardized photographs taken with a C Cube Caméra©.
The erythema of the skin
时间窗: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The erythema of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.
The pigmentation of the skin
时间窗: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The pigmentation of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.
The skin marks
时间窗: Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The skin marks are evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.
The wound healing quality
时间窗: Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The wound healing quality is evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.
The global efficacy of the product
时间窗: Day 19 - Visit 10
The global efficacy of the product is assessed by the subject with a 7-questions questionnaire.
The transepidermal water loss
时间窗: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
The transepidermal water loss is measured by a clinical research technician using a Vapometer©.
Standardized photographs in an illustrative purpose
时间窗: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.
Photographs in 2D and 3D are taken using a C Cube Camera©.
次要结局
未报告次要终点