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NCT Number: NCT07415798

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.

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

HKRI Centre One

Shanghai, Shanghai Municipality, 200072, China

Location status: Recruiting

Location contact

Yanwen Jiang

CONTACT

[email protected]

13501700841

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yanwen Jiang

CONTACT

[email protected]

13501700841

Sponsors and collaborators

Lead sponsor

ChinaNorm

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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