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)

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.

Study Overview

• Status: Recruiting
• Conditions: Female; Facial Skin

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Yanwen Jiang; Phone Number: 13501700841; Email: jiangyanwen@china-norm.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200072
      • Recruiting
      • HKRI Centre One
      • Contact: Yanwen Jiang; Phone Number: 13501700841; Email: jiangyanwen@china-norm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Approximately 100 healthy Chinese female Subjects, evenly distributed across age groups (20-29, 30-39, 40-49, 50-59, 60-70 years).

Description

Inclusion Criteria:

1. Chinese female, aged between 20 and 70 years (inclusive) at the time of signing consent.
2. Willing and able to provide written informed consent.
3. Fitzpatrick Skin Phototype II or III.
4. 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:

1. Pregnant, planning pregnancy, or breastfeeding (as hormonal changes significantly affect skin properties).
2. Presence of temporary tanning, sunburn, or significant erythema on the face or measurement areas.
3. Presence of facial piercings, tattoos, too much fluff or significant scarring that would interfere with imaging or measurements in the areas of interest.
4. 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.
5. 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.
6. 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.
7. Participation in another clinical study on the face or arms within the past 1 month.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Epidermal Thickness	Single visit, day 1
Dermal-Epidermal Junction (DEJ) Undulation Index	Single visit, day 1
Mean Dermal Reflectivity	Single visit, day 1
Stratum Corneum Thickness	Single visit, day 1
Correlation between LC-OCT parameters and chronological age	Single visit, day 1
Skin colorimetric parameter L*a*b*	Single visit, day 1
Correlation between LC-OCT parameters and clinician-graded scores	Single visit, day 1
Correlation between LC-OCT parameters and questionnaire factors	Single visit, day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ChinaNorm

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CN25038-CLI-SC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No