Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062943) titled 'A study to evaluate the effect after using baby diaper' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - DRC Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of improved Merries First Premium on children's skin using commercial diapers as a control Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Use the test diaper for 14 days. Interventions/Control_2 - Use the control diaper for 14 days.

Eligibility: Age-lower limit - 3 months-old = Gender - Male and Female Key inclusion criteria - Children 1) aged 3 months to 4 years at the time of consent acquisition, 2) using disposable diapers, 3) weighing 4-13kg at the start of the trial, 4) not attending nursery schools, certified children's centers, or daycare centers during the trial period, 5) whose diaper changes are mainly handled by the parents themselves. Parents 6) who can keep a diaper change diary for 14 days during the period (about 10 questions per exchange), 7) who can visit the facility with their child twice (the initial consultation and two weeks later), 8) who can respond to a pre-survey (1 time) of about 6 A4 pages and a post-survey (the same), 9) A parent who can agree that participation may be refused if any of the following conditions (1)-(4) are met at the start of the trial; (1) receiving outpatient treatment or medication at the start of the study, (2) having had an infectious disease (mumps, chickenpox, influenza, candidiatic dermatitis, etc.) from one month before until the start of the trial, (3) Used antibiotics and steroids from one month before the start of the study until the start of the trial, (4) with Diarrhea from one week before the start of the study until the start of the trial, 10) who can reliably meet deadlines for submitting survey and diary, 11) Children who do not participate in other monitoring activities or surveys from one week before the start of the trial until the end of the exam Key exclusion criteria - Children 1)diagnosed with chronic or congenital diseases and visit the clinic regularly, 2) with severe skin diseases on the diaper covering and visiting the clinic, 3)currently using antibiotics or steroids and may use them during the trial period, 4)whose necks are not stable yet, 5)deemed unsuitable as trial participants by the research staff Target Size - 64

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 25 Day Date of IRB - 2026 Year 09 Month 10 Day Anticipated trial start date - 2026 Year 10 Month 08 Day Last follow-up date - 2026 Year 10 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072050

Disclaimer: Curated by HT Syndication.