A Quantitative, Cross-Sectional and Observational Study to Characterize Age-Related Structural Changes in Facial Skin of Chinese Women Using Line-Field Confocal Optical Coherence Tomography (LC-OCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Epidermal Thickness
研究概览
简要总结
This is a single-center, non-interventional, observational, cross-sectional clinical study designed to quantitatively and qualitatively characterize skin properties in a cohort of 100 Chinese female Subjects aged 20 to 70 years. The study involves no product application and poses minimal risk to participants. The primary objectives are to establish a comprehensive skin aging profile database, characterize skin color, aging signs, and biomechanical properties, and create a histomorphometric database for the development and validation of ordinal photographic scales for aging research. Data will be collected through questionnaires, clinical assessments (including LC-OCT imaging), standardized photography, and non-invasive biophysical measurements. All procedures will be conducted in accordance with the ethical principles originating from the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the relevant laws and regulations of China (including the *Measures for the Ethical Review of Biomedical Research Involving Human Subjects*). All data will be anonymized and stored securely.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese female, aged between 20 and 70 years (inclusive) at the time of signing consent.
- •Willing and able to provide written informed consent.
- •Fitzpatrick Skin Phototype II or III.
- •Willing to comply with all study procedures, including removal of facial makeup and avoidance of intensive skincare (e.g., retinoids, strong acids) on the test areas for 3 days prior to the visit as per instructions.
排除标准
- •Pregnant, planning pregnancy, or breastfeeding (as hormonal changes significantly affect skin properties).
- •Presence of temporary tanning, sunburn, or significant erythema on the face or measurement areas.
- •Presence of facial piercings, tattoos, too much fluff or significant scarring that would interfere with imaging or measurements in the areas of interest.
- •History of any aesthetic or surgical procedure on the face (e.g., laser therapy, chemical peels, injectable fillers, botulinum toxin, plastic surgery) within the past 12 months.
- •Current diagnosis or visible signs of a skin disease (e.g., psoriasis, eczema, active acne, rosacea) or a systemic disease known to affect the skin (e.g., diabetes, lupus) on the face or measurement areas.
- •Use of systemic medications known to affect skin physiology (e.g., oral retinoids, immunosuppressants, long-term corticosteroids) within the past 3 months, or for a cumulative duration of ≥6 months within the past 2 years.
- •Participation in another clinical study on the face or arms within the past 1 month.
研究组 & 干预措施
Group 20 to 29 Years old
Group 30 to 39 Years old
Group 40 to 49 Years old
Group 50 to 59 Years old
Group 60 to 69 Years old
结局指标
主要结局
Epidermal Thickness
时间窗: Single visit, day 1
Dermal-Epidermal Junction (DEJ) Undulation Index
时间窗: Single visit, day 1
Mean Dermal Reflectivity
时间窗: Single visit, day 1
Stratum Corneum Thickness
时间窗: Single visit, day 1
Correlation between LC-OCT parameters and chronological age
时间窗: Single visit, day 1
Skin colorimetric parameter L*a*b*
时间窗: Single visit, day 1
Correlation between LC-OCT parameters and clinician-graded scores
时间窗: Single visit, day 1
Correlation between LC-OCT parameters and questionnaire factors
时间窗: Single visit, day 1
次要结局
- Clinician-graded score of skin texture/pores(Single visit, day 1)
- Clinician-graded score of skin pigmentation(Single visit, day 1)
- Clinician-graded score of facial wrinkles(Single visit, day 1)