Multidimensional Correlation Study on Skin Aging in Menopausal Women

ChinaNorm

Status: Completed

Conditions: Reproductive Aging; Menopause; Skin Aging; Genetic Factors

Study type: Observational

Funder types: Industry

Identifiers

NCT07390305

W25006001

Details and patient eligibility

About

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. 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Participants must possess basic Chinese literacy skills (reading comprehension and expression) to complete questionnaires independently.

2. Voluntary participation and signed informed consent.

3. Willingness to comply with all study requirements and assessments.

4. Early Perimenopausal Group：

   1. Healthy women aged 45-50 (±3) years.
   2. 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).

5. Late Perimenopausal Group：

   1. Healthy women aged 50-55 (±3) years.

   2. 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：

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   1. Healthy women aged 55-60 (±3) years.
   2. STRAW Stage +1 / Postmenopause: Last menstrual period occurred at least 12 months prior.

7）Young Control Group：

1. Healthy women aged 18-25 (±3) years.

2. Biological daughters of participants in either the Late Perimenopausal Group or the Postmenopausal Group.

3. Regular menstrual cycle, with a cycle length ranging between 25-35 days. Exclusion Criteria

   1. Presence of open wounds, clearly visible scars, acne marks, or other significant skin imperfections at the measurement sites.
   2. History of skin diseases affecting the evaluation of the study areas (e.g., psoriasis, atopic dermatitis, skin cancer).
   3. Women who are currently pregnant or breastfeeding.
   4. Use of systemic estrogen or progesterone hormone replacement therapy within the past 6 months.
   5. Presence of acute or severe chronic diseases currently under treatment.
   6. Any known condition that significantly impairs cognitive or behavioral abilities.
   7. Considered by the investigator or qualified professional to have other medical or specific reasons that may interfere with the evaluation of study results.
   8. Early Perimenopausal Group & Late Perimenopausal Group & Postmenopausal Group:

a) 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.

c) History of breast cancer or oophorectomy. 9） Young Control Group:

1. Currently planning for pregnancy, pregnant, or lactating.
2. Diagnosis of Polycystic Ovary Syndrome (PCOS).

Trial design

100 participants in 4 patient groups

Early Perimenopausal Group

Late Perimenopausal Group

Postmenopausal Group

Young Control Group