Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059207) titled 'Study on promoting caregiver behavior change to protect infant skin barrier' on Sept. 26.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - SHISEIDO

Condition: Condition - Skin barrier Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - It is known that skin condition changes as people grow, and infant skin is immature and fragile, with particularly weak barrier function and differing levels of stratum corneum factors. Therefore, our company aims to examine whether assessing and providing information about skin condition from infancy can contribute to the protection of the skin barrier, and to explore its practical application. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Seminar participation and stratum corneum sampling

Eligibility: Age-lower limit - 2 months-old

Gender - Male and Female Key inclusion criteria - Healthy infants aged 2 to 11 months living in Japan (regardless of nationality) and their caregivers. Key exclusion criteria - Infants with allergic conditions such as atopic dermatitis or food allergies at the time of the study Infants currently taking medication, or those who require or are scheduled to require regular medication Infants with noticeable skin issues, wounds, scars, swelling (e.g., from bruises), or skin disorders on the test area (cheeks to around the mouth) Infants who are currently experiencing excessive sunburn or are expected to engage in activities during the study period that may cause excessive sun exposure (e.g., swimming in the ocean, mountain climbing, sunbathing, skiing) Infants currently participating in other studies involving medical products, pharmaceuticals, cosmetics, or food intake, or scheduled to participate during the study period Any other individuals deemed unsuitable for participation by the principal investigator or co-investigators Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 06 Day Date of IRB - 2025 Year 09 Month 04 Day Anticipated trial start date - 2025 Year 09 Month 26 Day Last follow-up date - 2026 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067719

Disclaimer: Curated by HT Syndication.