AzTrials
AzTrials

Skin AgingNCT07390305

Multidimensional Correlation Study on Skin Aging in Menopausal Women

An observational study of Skin Aging and Reproductive Aging, run by ChinaNorm at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: This study primarily aims to compare skin aging characteristics between women at different stages of reproductive aging in both sun-exposed and non-exposed areas, based on skin indicators collected during a single laboratory visit. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Aging, Reproductive Aging, Menopause
How many people
100 participants
Where
1 siteChina
Study dates
11 Nov 2025to 20 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

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 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: This study enrolled adult women categorized into four distinct groups based on their reproductive aging stage according to the STRAW+10 staging system: a Young Control Group (aged 18-25, biological daughters of participants in the older groups, with regular menstrual cycles), an Early Perimenopausal Group (aged 45-50, with a persistent change in menstrual cycle length >7 days), a Late Perimenopausal Group (aged 50-55, experiencing ≥2 consecutive cycles of ≥60 days or amenorrhea of ≥60 days), and a Postmenopausal Group (aged 55-60, with the last menstrual period occurring at least 12 months prior). All participants were recruited as mother-daughter pairs, where the young control group consisted of the biological daughters of participants in the late perimenopausal and postmenopausal groups .

Who may be able to join

  • Participants must possess basic Chinese literacy skills (reading comprehension and expression) to complete questionnaires independently.
  • Voluntary participation and signed informed consent.
  • Willingness to comply with all study requirements and assessments.
  • Early Perimenopausal Group:
  • Healthy women aged 45-50 (±3) years.
  • STRAW Stage -2 / Early Perimenopause: Experiencing a persistent change in menstrual cycle length of >7 days from their normal cycle, but with no occurrence of 60 or more days of amenorrhea (i.e., still having menstrual periods).
Show all 29Show fewer
  • Late Perimenopausal Group:
  • Healthy women aged 50-55 (±3) years.
  • STRAW Stage -1 / Late Perimenopause: Experiencing ≥2 consecutive cycles with a length of ≥60 days, or the presence of ≥60 days of amenorrhea.
  • 6) Postmenopausal Group:
  • <!-- -->
  • Healthy women aged 55-60 (±3) years.
  • STRAW Stage +1 / Postmenopause: Last menstrual period occurred at least 12 months prior.
  • 7)Young Control Group:
  • Healthy women aged 18-25 (±3) years.
  • Biological daughters of participants in either the Late Perimenopausal Group or the Postmenopausal Group.
  • Regular menstrual cycle, with a cycle length ranging between 25-35 days. Exclusion Criteria
  • Presence of open wounds, clearly visible scars, acne marks, or other significant skin imperfections at the measurement sites.
  • History of skin diseases affecting the evaluation of the study areas (e.g., psoriasis, atopic dermatitis, skin cancer).
  • Women who are currently pregnant or breastfeeding.
  • Use of systemic estrogen or progesterone hormone replacement therapy within the past 6 months.
  • Presence of acute or severe chronic diseases currently under treatment.
  • Any known condition that significantly impairs cognitive or behavioral abilities.
  • Considered by the investigator or qualified professional to have other medical or specific reasons that may interfere with the evaluation of study results.
  • Early Perimenopausal Group \& Late Perimenopausal Group \& Postmenopausal Group:
  • Current use of systemic hormone replacement therapy (HRT). b) Topical application of anti-aging products (e.g., retinoids, alpha/beta hydroxy acids) on the measurement areas within the past 3 months.
  • History of breast cancer or oophorectomy. 9) Young Control Group:
  • Currently planning for pregnancy, pregnant, or lactating.
  • Diagnosis of Polycystic Ovary Syndrome (PCOS).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai China-norm Quality Technical Service Co., Ltd.

    Shanghai, Shanghai Municipality, 200072

Other trials in China

About this study

Official title: Study on the Correlation Between Skin Aging in Exposed / Non Exposed Areas and Menopausal Symptoms, Emotions, and Sleep in Menopausal Women

Primary Objective:

This study primarily aims to compare skin aging characteristics between women at different stages of reproductive aging in both sun-exposed and non-exposed areas, based on skin indicators collected during a single laboratory visit. Furthermore, through a 30-day at-home tracking period (for the late-stage and postmenopausal groups) or one menstrual cycle (for the early-stage and young group), we seek to analyze the temporal dynamics of changes in skin condition, mood, sleep quality, and menopausal hot flashes.

Read more

Secondary Objective:

The secondary objective is to examine differences in skin conditions across life stages by recruiting mother-daughter pairs (where the young group consists of the biological daughters of the late-stage and postmenopausal groups). The core focus is to leverage shared genetic backgrounds to explore how skin characteristics, particularly in different body areas, may change over time or in response to hormonal fluctuations. By comparing these characteristics across age groups, this study seeks to identify key variation patterns and their contributing factors, thereby laying the groundwork for further mechanistic investigations and practical applications.

Keywords
Skin Aging, Reproductive Aging, Menopause, Exposed/Non-Exposed Skin Sites, Hormonal Fluctuations, Genetic Factors, Mother-Daughter Pairs, Longitudinal Tracking, Skin Biophysical Properties

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07390305
Study groupRoleWhat they receive
Early Perimenopausal GroupNot described
Late Perimenopausal GroupNot described
Postmenopausal GroupNot described
Young Control GroupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Assessment

    This assessment involves a clinical evaluation of skin aging degree performed by dermatologists at the T1 time point. The evaluation is conducted according to the skin aging scales outlined in the "Human Skin Aging Evaluation Standard" . It targets both exposed areas (face, dorsum of hands) and non-exposed areas (inner side of the upper arm, outer upper hip region) to differentiate between intrinsic and extrinsic aging factors. Specific skin lesions, such as epidermal/vascular proliferations, are assessed as separate individual items.

    Measured: The assessment is performed as a single evaluation at the T1 (baseline) laboratory visit .

  2. Skin Wrinkle and Smoothness Assessment

    This assessment quantitatively evaluates skin surface topography using a dedicated imaging system. The instrument captures high-resolution grayscale images of the skin's surface. The built-in Skin Evaluation Living Skin (SELS) software then analyzes the image to extract objective numerical values for key parameters. The primary indicators measured are: SEw (Surface Evaluation of Wrinkles), where a higher value indicates more pronounced wrinkles; and SEsm (Surface Evaluation of Smoothness), where a lower value indicates smoother skin.

    Measured: The assessment is conducted as a single measurement at the T1 (baseline) time point .

  3. Skin Color Measurement with Colorimeter

    This assessment quantitatively measures skin color using the Colorimeter probe. The instrument emits white LED light from a ring-shaped configuration to ensure even illumination of the skin surface. The light scatters upon contact, with some penetrating the skin and some being reflected. The probe captures the reflected light, and the raw data is corrected via a specialized color matrix to approximate standard values. The skin color is expressed in XYZ tristimulus values and converted into the standardized CIE Lab* color space parameters. The L* value represents lightness (brightness) on a black-white axis. The a* value indicates the position on the red-green axis (often interpreted as erythema or red pigment), and the b* value indicates the position on the blue-yellow axis (often associated with yellow pigment). Additionally, the Individual Typology Angle (ITA°) value is automatically calculated, where a higher ITA° value indicates lighter skin.

    Measured: The measurement is performed as a single assessment at the T1 (baseline) laboratory visit.

  4. Skin Elasticity Measurement with Cutometer® MPA580

    The Cutometer® MPA580 assesses skin mechanical properties based on the suction and stretch principle. It applies a controlled negative pressure to the skin, drawing it into the probe aperture. The depth of skin deformation is measured optically by the ratio of light emitted to light received within the probe. Key parameters extracted for this study include R2 (Gross Elasticity) and F4 (Firmness). The R2 value, representing the ratio of total retraction to total deformation, approaches 1 for highly elastic skin. The F4 value corresponds to the skin's firmness or resistance to the suction force; a lower F4 value indicates firmer, more resistant skin .

    Measured: The measurement is performed as a single assessment at the T1 (baseline) laboratory visit .

  5. Skin Ultrasound Diagnostic System Ultrascan UC22

    The Ultrascan UC22 is a high-frequency ultrasound imaging system used for non-invasive assessment of skin microstructure. It operates by emitting a 22 MHz ultrasound signal into the skin; the echoes reflected from internal skin structures are captured and digitally processed to generate high-resolution, cross-sectional images. This allows for the in vivo measurement of key parameters related to skin aging, primarily skin thickness and skin density (which correlates with collagen density and tissue structure). This tool is particularly valuable for objectively evaluating intrinsic skin aging and the efficacy of cosmetic interventions in research settings.

    Measured: The measurement is performed as a single assessment at the T1 (baseline) laboratory visit.

  6. Skin Moisture Loss Meter Vapometer

    he Vapometer is a portable device designed to measure Transepidermal Water Loss (TEWL), a key indicator of the skin barrier's functional integrity. Its operation is based on the closed-chamber principle. The core of the instrument is a highly sensitive humidity sensor located within a cylindrical measurement chamber. During measurement, this chamber is sealed against the skin surface, creating a microenvironment protected from ambient air currents. The sensor monitors the increase in relative humidity (RH) inside the chamber caused by the evaporation of water from the skin. The TEWL value, expressed in grams per square meter per hour (g/m²h), is automatically calculated from this rate of humidity increase . This method is particularly suitable for detecting changes in skin water loss and is widely used in dermatological research and cosmetic efficacy evaluations.

    Measured: The measurement is performed as a single assessment at the T1 (baseline) laboratory visit .

  7. Skin Hemoglobin Measurement with Mexameter® MX18

    The Mexameter® MX18 is a specialized probe that quantitatively assesses skin color by measuring the two primary chromophores: melanin and hemoglobin. It operates on the principle of light absorption and reflection.

    Measured: The assessment is performed as a single measurement at the T1 (baseline) laboratory visit .

  8. Intelligent Skin Analyzer Skinmeter

    The Skinmeter is a portable device designed for the non-invasive assessment of key skin physiological parameters. For the purpose of this study, the primary focus of the measurement is on the skin hydration (moisture) parameter.

    Measured: The measurement is performed at three designated time points during the study: T1( Day1),T2(Day 15), and T3(Day 30).

  9. Skin Sebum Measurement with Sebum-Test Paper

    This method quantitatively assesses skin sebum (oil) content using a specialized oil-absorbent test paper and subsequent image analysis.

    Measured: The measurement is performed at three designated time points during the study: T1( Day1),T2(Day 15), and T3(Day 30).

  10. Sleep Duration Recording

    This component utilizes the smart band monitoring algorithm to objectively record participants' sleep patterns. The algorithm employs a multi-modal approach, integrating data from accelerometers (to monitor body movement) and photoplethysmography (PPG) sensors (to monitor heart rate and heart rate variability) . By analyzing the correlation between physiological signals such as body movement, heart rate, and their variability with sleep states, it constructs a fusion algorithm model to accurately identify sleep stages and calculate total sleep duration . This non-invasive method allows for convenient, at-home sleep monitoring over extended periods.

    Measured: Sleep data is collected continuously throughout the entire tracking period of the study.Day1 to Day 30.

Secondary outcomes (6)
  1. BMI

    Body Mass Index (BMI) is a widely used international standard for assessing body weight and health status. It is a numerical value calculated from an individual's weight and height.

    Measured: BMI is measured during the baseline laboratory visit.

  2. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire widely used to assess subjective sleep quality over a specified period.

    Measured: The PSQI questionnaire will be administered at three designated time points during the study: Day1, Day15, and Day30. At each assessment, participants will be asked to recall and report on their sleep quality and disturbances over the past 1 week .

  3. Generalized Anxiety Disorder-7 (GAD-7)

    The Generalized Anxiety Disorder-7 (GAD-7) is a self-report questionnaire utilized for screening and assessing the severity of generalized anxiety disorder. As a component of the Patient Health Questionnaire (PHQ) series, it consists of 7 items that inquire about the frequency of core anxiety symptoms-such as feeling nervous, anxious, or on edge, and being unable to control worrying-over a specified period. Respondents rate each item on a 4-point scale. The total score (ranging from 0 to 21) helps categorize anxiety severity, facilitating initial assessment and monitoring of symptoms.

    Measured: he questionnaire is administered at three designated time points during the study: T1(Day1), T2(Day15), and T3(Day30). At each assessment, participants are asked to recall and report on their experiences over the past two weeks .

  4. Patient Health Questionnaire-8 Items (PHQ-8)

    The Patient Health Questionnaire-8 (PHQ-8) is a standardized self-report instrument widely used to screen for and measure the severity of depressive symptoms . It consists of 8 items that correspond to the diagnostic criteria for depressive disorders. Respondents rate the frequency of each symptom over a specified recall period on a 4-point scale (0 to 3). The total score, ranging from 0 to 24, helps categorize depressive severity, from none to severe . It is a reliable and valid tool for use in both clinical and research settings.

    Measured: The questionnaire is administered at three specific time points during the study: T1 (Day1), T2(Day15), and T3(Day30). At each assessment, participants are asked to report on their experiences over the past two weeks .

  5. Assessment of Hot Flash Frequency and Impact on Daily Life

    This questionnaire is designed to assess the frequency and subjective impact of hot flashes (also known as vasomotor symptoms) on an individual's daily life. The instrument draws on core concepts from established tools, including the Kupperman Menopausal Index (KMI) and the Hot Flush Rating Scale (HFRS). It evaluates two primary dimensions: 1) the frequency of hot flash episodes over a specified period, and 2) the degree of interference these symptoms cause to various aspects of daily living, such as work, mood, sleep, and social activities. The aim is to provide a quantitative and qualitative measure of the burden of hot flashes

    Measured: This questionnaire is to be completed daily throughout the testing period. Participants are asked to recall and report on their hot flash experiences over the past 24 hours.From Day1 to Day30.

  6. Ultraviolet (UV) Exposure Questionnaire

    This component quantitatively evaluates participants' real-life exposure to ultraviolet (UV) radiation and their photoprotection practices over a specified period. It encompasses key dimensions such as: 1. Sun Protection Behaviors: Frequency of use and types of physical protection (e.g., wide-brimmed hats, long-sleeved clothing) and sunscreen (including Sun Protection Factor, or SPF). 2. Outdoor Activity Patterns: Time spent outdoors for both occupational and recreational activities. The aim is to estimate individual UV exposure dose and identify potential risk factors for skin damage.

    Measured: The questionnaire assesses UV exposure behaviors and sun protection habits over the past 1 month and is administered at the T1 (baseline) laboratory visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start11 Nov 2025
  3. Primary completion20 Jan 2026
  4. Study completion20 Jan 2026

Resources

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
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390305
Sponsor's protocol ID
W25006001
Status last verified
Feb 2026
First submitted
12 Jan 2026
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Aging and Reproductive Aging, 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 29 inclusion and 0 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: finished, as of the sponsor's last update on 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Assessment (time frame: The assessment is performed as a single evaluation at the T1 (baseline) laboratory visit .). The study lists 10 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 5 Feb 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in