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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Female, Facial Skin. Basic parameters: 20 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Epidermal Thickness [Time frame: Single visit, day 1]
- Dermal-Epidermal Junction (DEJ) Undulation Index [Time frame: Single visit, day 1]
- Mean Dermal Reflectivity [Time frame: Single visit, day 1]
- Stratum Corneum Thickness [Time frame: Single visit, day 1]
- Correlation between LC-OCT parameters and chronological age [Time frame: Single visit, day 1]
- Skin colorimetric parameter L*a*b* [Time frame: Single visit, day 1]
- Correlation between LC-OCT parameters and clinician-graded scores [Time frame: Single visit, day 1]
- Correlation between LC-OCT parameters and questionnaire factors [Time frame: Single visit, day 1]
Secondary outcome measures (3)
- Clinician-graded score of skin texture/pores [Time frame: Single visit, day 1]
- Clinician-graded score of skin pigmentation [Time frame: Single visit, day 1]
- Clinician-graded score of facial wrinkles [Time frame: Single visit, day 1]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- HKRI Centre One — Shanghai
Identifiers
NCT: NCT07415798 · CN25038-CLI-SC