FemaleNCT07415798
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 of Female and Facial Skin, run by ChinaNorm at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, Facial Skin
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 100 healthy Chinese female Subjects, evenly distributed across age groups (20-29, 30-39, 40-49, 50-59, 60-70 years).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
HKRI Centre One
Shanghai, Shanghai Municipality, 200072
Yanwen Jiang, 13501700841, jiangyanwen@china-norm.com
About this study
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.
- Conditions
- Female, Facial Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 20 to 29 Years old | Not described | |
| Group 30 to 39 Years old | Not described | |
| Group 40 to 49 Years old | Not described | |
| Group 50 to 59 Years old | Not described | |
| Group 60 to 69 Years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal Thickness
Measured: Single visit, day 1
Dermal-Epidermal Junction (DEJ) Undulation Index
Measured: Single visit, day 1
Mean Dermal Reflectivity
Measured: Single visit, day 1
Stratum Corneum Thickness
Measured: Single visit, day 1
Correlation between LC-OCT parameters and chronological age
Measured: Single visit, day 1
Skin colorimetric parameter L*a*b*
Measured: Single visit, day 1
Correlation between LC-OCT parameters and clinician-graded scores
Measured: Single visit, day 1
Correlation between LC-OCT parameters and questionnaire factors
Measured: Single visit, day 1
Secondary outcomes (3)
Clinician-graded score of skin texture/pores
Measured: Single visit, day 1
Clinician-graded score of skin pigmentation
Measured: Single visit, day 1
Clinician-graded score of facial wrinkles
Measured: Single visit, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415798
- Sponsor's protocol ID
- CN25038-CLI-SC
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07415798
- Acronym / sponsor ID
- CN25038-CLI-SC
- Conditions
- Female, Facial Skin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 100 healthy Chinese female Subjects, evenly distributed across age groups (20-29, 30-39, 40-49, 50-59, 60-70 years).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female and Facial Skin, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidermal Thickness (time frame: Single visit, day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.