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)
| NCT ID | NCT07415798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ChinaNorm |
| Condition | Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-01-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07415798 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 70 Years, studying Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07415798 currently recruiting?
Yes, NCT07415798 is actively recruiting participants. Contact the research team at jiangyanwen@china-norm.com for enrollment information.
Where is the NCT07415798 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07415798 clinical trial?
NCT07415798 is sponsored by ChinaNorm. The trial plans to enroll 100 participants.