Multidimensional Correlation Study on Skin Aging in Menopausal Women

What this trial studies

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. 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.

Conditions in scope

• Skin Aging
• Reproductive Aging
• Menopause
• Genetic Factors

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 18 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

• 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).
• Late Perimenopausal Group：
• Healthy women aged 50-55 (±3) years.

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:

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2025-11-11
• Primary completion: 2026-01-20
• Last update posted: 2026-02-05
• First posted: 2026-02-05

Sponsor & contact

Lead sponsor: ChinaNorm (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Clinical Assessment (The assessment is performed as a single evaluation at the T1 (baseline) laboratory visit .)
  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…
• Skin Wrinkle and Smoothness Assessment (The assessment is conducted as a single measurement at the T1 (baseline) time point .)
  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;…
• Skin Color Measurement with Colorimeter (The measurement is performed as a single assessment at the T1 (baseline) laboratory visit.)
  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…
• Skin Elasticity Measurement with Cutometer® MPA580 (The measurement is performed as a single assessment at the T1 (baseline) laboratory visit .)
  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…
• Skin Ultrasound Diagnostic System Ultrascan UC22 (The measurement is performed as a single assessment at the T1 (baseline) laboratory visit.)
  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…

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