Development of a Clinical Photographic Atlas for Skin Aging Based on the Characterization of Facial Dermal Collagen Using LC-OCT Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Non-invasive tissue imaging: 3D imaging through Line-field Confocal Optical Coherence Tomography technology (LC-OCT) acquisitions
研究概览
简要总结
This is a single-center, single visit study conducted in healthy female subjects, aged 20 to 75 years inclusive meeting specific inclusion/exclusion criteria. The study is to develop a clinical photographic atlas to assess skin aging by studying the relationship between age, sun exposure and quantity of collagen measured non-invasively (LC-OCT). No product will be tested during the study.
详细描述
Single-center, single visit study in healthy female subjects, aged 20 to 75 years inclusive meeting specific inclusion/exclusion criteria. The study is to develop a clinical photographic atlas to assess skin aging by studying the relationship between age, sun exposure and quantity of collagen measured non-invasively (LC-OCT). No product will be tested during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
- •Healthy female subject aged 20 to 75 years inclusive at the time of signing the ICF;
- •Subject with a phototype I to III on Fitzpatrick's scale;
- •Subject who is willing to follow the study procedures and to complete the study course;
- •Subject registered with Social Security in agreement with French law on study research.
排除标准
- •Male subject;
- •Female subject who is pregnant or who is breast feeding;
- •Subject with current participation in any other interventional clinical study, based on interview of the subject;
- •Subject with facial dermatitis, rosacea, acne, eczema, psoriasis, skin rashes, open lesions, vitiligo or viral conditions such as herpes labialis;
- •Subject who has collagen vascular disease, a significant systemic disease, immunological problems or inflammatory skin conditions on the face;
- •Subject who has had a face lift;
- •Subject has had a non-ablative and/or ablative laser procedure on the face in the past 3 months;
- •Subject with a history of botulinum toxin or mesotherapy injections on the face within the last 6 months, or absorbable fillers injections (such as hyaluronic acid or autologous fat…) in the last 12 months or injectable implants (semi-permanent fillers) within the last 24 months;
- •Subject having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months;
- •Subject having applied any cosmetic product (care cream, lotion, makeup) except usual cleansing products or any drug to her face on the day of the visit;
- •Subject who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or subject hospitalized in a medical or social establishment for any reason.
研究组 & 干预措施
Group 1: 20-30 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on the forehead (Diagnostic Test)
Group 1: 20-30 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform standardized photographs using ColorFace (Device)
Group 1: 20-30 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on forehead (Device)
Group 1: 20-30 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform photo-shooting using smartphones (Device)
Group 2: 31-40 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on the forehead (Diagnostic Test)
Group 2: 31-40 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform standardized photographs using ColorFace (Device)
Group 2: 31-40 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on forehead (Device)
Group 2: 31-40 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform photo-shooting using smartphones (Device)
Group 3: 41-50 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on the forehead (Diagnostic Test)
Group 3: 41-50 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform standardized photographs using ColorFace (Device)
Group 3: 41-50 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on forehead (Device)
Group 3: 41-50 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform photo-shooting using smartphones (Device)
Group 4: 51-60 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on the forehead (Diagnostic Test)
Group 4: 51-60 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform standardized photographs using ColorFace (Device)
Group 4: 51-60 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on forehead (Device)
Group 4: 51-60 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform photo-shooting using smartphones (Device)
Group 5: 61-75 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on the forehead (Diagnostic Test)
Group 5: 61-75 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform standardized photographs using ColorFace (Device)
Group 5: 61-75 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: LC-OCT acquisitions on forehead (Device)
Group 5: 61-75 years
The subjects will attend one single visit during which standardized photographs of the face (front and 45° left and right sides), photo shooting with a smartphone (back and front captures), LC-OCT microscopy image acquisition will be realized. The subject will have also to answer a questionnaire.
干预措施: Perform photo-shooting using smartphones (Device)
结局指标
主要结局
Non-invasive tissue imaging: 3D imaging through Line-field Confocal Optical Coherence Tomography technology (LC-OCT) acquisitions
时间窗: Day 1
Line-field Confocal Optical Coherence Tomography technology (LC-OCT) provides a unique 3D imaging modality, allowing the user to switch from a histology-like vertical mode to confocal-like horizontal mode and to record a 3D stack of tissue volumes in situ. With this technique skin can be imaged in vivo in its native state without further preparation. The superficial dermis can be clearly imaged using a live vertical, live horizontal and 3D mode. This assessment will be performed on the face (forehead) with the LC-OCT deepLive™ (DAMAE). This non invasive image will helps to characterize and quantify new metrics of skin aging linked to the dermal fibers network (collagen and elastin) such as caracterisation of the density and length of dermis fibers during aging.
次要结局
- Standardized photographs of the face (front and 45° left and right sides)(Day 1)
- Photo shooting(Day 1)
- Questionnaire(Day 1)