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RecruitingNCT07415798Updated Feb 17, 2026

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)

An observational study in Female and Facial Skin, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to female participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by ChinaNorm · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
20 Years to 70 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Female
  • Facial Skin
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
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).

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

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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
05

What researchers measure

Primary outcomes

  1. Epidermal Thickness

    Time frame: Single visit, day 1

  2. Dermal-Epidermal Junction (DEJ) Undulation Index

    Time frame: Single visit, day 1

  3. Mean Dermal Reflectivity

    Time frame: Single visit, day 1

  4. Stratum Corneum Thickness

    Time frame: Single visit, day 1

  5. Correlation between LC-OCT parameters and chronological age

    Time frame: Single visit, day 1

  6. Skin colorimetric parameter L*a*b*

    Time frame: Single visit, day 1

  7. Correlation between LC-OCT parameters and clinician-graded scores

    Time frame: Single visit, day 1

  8. Correlation between LC-OCT parameters and questionnaire factors

    Time frame: Single visit, day 1

Secondary outcomes

  1. Clinician-graded score of skin texture/pores

    Time frame: Single visit, day 1

  2. Clinician-graded score of skin pigmentation

    Time frame: Single visit, day 1

  3. Clinician-graded score of facial wrinkles

    Time frame: Single visit, day 1

06

Study locations

1 of 1 sites recruiting
  • HKRI Centre One
    Shanghai, Shanghai Municipality 200072, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07415798
Lead sponsor
ChinaNorm
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Jan 15, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Yanwen Jiang
Contact
jiangyanwen@china-norm.com
13501700841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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