Tokyo, March 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060908) titled 'Survey on changes in skin condition due to female hormones around menopause' on March 16.
Study Type:
Observational
Primary Sponsor:
Institute - Pias Corporation
Condition:
Condition - healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - to survey changes in skin condition due to female hormones around menopause
Basic objectives2 - Others
Eligibility:
Age-lower limit - 45
years-old
=
Gender - Female
Key inclusion criteria - 1) Japanese females aged 45 to 55 years old at the time of informed consent
2) Those who can consent to undergoing tape stripping, applying and removing tape to the skin 20 times on the same location on the inner upper arm
Key exclusion criteria - 1) Those suspected of having, or with a history of, severe digestive, liver, kidney, cardiovascular, blood, or endocrine disorders, or malignant neoplasms
2) Those with extremely irregular eating habits
3) Those with a history of alcohol or drug dependence
4) Those who consume excessive amounts of alcohol (exceeding 20g/day) six or more days per week
5) Those with chronic inflammation (e.g., diabetes, liver disease, autoimmune disorders), kidney disease, digestive disorders, heart disease, respiratory disease, peripheral vascular disease, or other serious underlying conditions
6) Those currently undergoing treatment for any disease
7) Those currently taking medications (including over-the-counter products) or supplements with estrogenic effects
8) Those currently participating in another clinical trial, or who participated within the past month
9) Those who wish to become pregnant during the trial, are pregnant (including those who may be pregnant), or are breastfeeding
10) Those with current allergic skin conditions such as atopic dermatitis
11) Those who have experienced allergic reactions to food or cosmetics
12) Those who have undergone cosmetic medical procedures or special skincare treatments (e.g., peeling, hair removal) within 4 weeks prior to the trial start date, or plan to undergo such procedures during the trial period
13) Those who have been exposed to ultraviolet rays beyond normal daily activities (e.g., prolonged outdoor work, exercise, swimming, leisure activities) within 4 weeks prior to the trial start date, or who plan to do so during the trial period
14) Those with irregular daily rhythms, such as night shift workers or those on rotating day-night shifts
15) Those who smoke an average of 21 or more cigarettes per day
16) Those who engage in strenuous sports or are currently dieting
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 11 Day
Date of IRB - 2026 Year 03 Month 12 Day
Anticipated trial start date - 2026 Year 03 Month 13 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069547
Disclaimer: Curated by HT Syndication.