Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059397) titled 'Observational Study on Physical and Mental Discomfort' on Oct. 15.

Study Type: Observational

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy Adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Screening for inflammatory risk factors (SCR) will be conducted to assess smoking status, stress levels, dietary habits, and alcohol consumption. Based on fatigue and insomnia status, subjects will be classified into four groups (A, B1, B2, and C). Biological data, including inflammatory markers and facial image data, will be collected from each group to obtain data for identifying subjects with chronic inflammatory conditions. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - (1) Men and women aged 40 years or older and under 56 years at the time of obtaining informed consent. (2) Individuals who have sufficient decision-making capacity, have received a full explanation of the purpose and content of this study, fully understand the information provided, and voluntarily agree to participate by providing their own written informed consent. Key exclusion criteria - (1) Individuals who regularly use drugs affecting the evaluation (e.g., steroids, anti-allergic agents, immunosuppressants, antihistamines). (2) Individuals with severe allergic diseases such as pollinosis. (3) Individuals under dermatological treatment for facial skin. (4) Individuals who routinely use therapeutic topical agents on the face. (5) Individuals with skin conditions such as atopic dermatitis. (6) Individuals using a cardiac pacemaker. (7) Individuals with or with a history of serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic diseases. (8) Individuals with chronic diseases (e.g., diabetes, hyperlipidemia, hypertension) under medical treatment. (9) Individuals who received cosmetic procedures such as laser treatment, peeling, or long-lasting facial hair removal within the past year. (10) Individuals currently visiting a clinic for aesthetic treatment or skin problems. (11) Individuals expected to have excessive sun exposure to the face (e.g., sea or pool) from October 22 to December 18, 2025. (12) Individuals who received or plan to receive tanning, cosmetic, or aesthetic treatments on the face during the same period. (13) Individuals who experienced discomfort or health problems from blood sampling. (14) Individuals suspected of infection with hepatitis B, hepatitis C, syphilis, or HIV. (15) Women who are pregnant, possibly pregnant, breastfeeding, or intending pregnancy during the study. (16) Individuals unable to maintain their usual lifestyle due to travel, relocation, exams, or other major events during the study period. (17) Individuals currently in another study, within four weeks of prior study participation, or planning to join another study. (18) Individuals judged ineligible by the principal investigator. Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 09 Day Date of IRB - 2025 Year 10 Month 14 Day Anticipated trial start date - 2025 Year 10 Month 15 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067929

Disclaimer: Curated by HT Syndication.