Tokyo, Feb. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060708) titled 'Effects of Long-term HAGmi Application on Skin Microbiota and Stratum Corneum Condition' on Feb. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - BIOSIS Lab. Co., Ltd.

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

Objective: Narrative objectives1 - This study aims to investigate the impact of a 4-week application of HAGmi on skin microbiota and corneal layer moisture content in male and female subjects between the ages of 18 and under 70. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Apply either Test Product A or Test Product B to the right cheek twice daily (morning and evening) for four consecutive weeks Interventions/Control_2 - Apply either Test Product A or Test Product B to the left cheek twice daily (morning and evening) for four consecutive weeks

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate 2.Persons who are Japanese citizens, aged 18 or older and under 70 at the time of consent Key exclusion criteria - 1.Persons who may develop skin irritation or roughness upon application of the test product (HAGmi) 2.Persons who have a chronic disease and are receiving medical treatment, or those with a history of serious illness. 3.Persons who habitually use the test product (HAGmi) (three or more days per week), or those who have done so within one month prior to the pre-study screening 4.Persons who usually take medicine, specified health food, healthy food and supplements that may have the skin condition or other supplements that are expected to have cosmetic effects 5.Persons who regularly use vitamin A (tretinoin, retinol, retinol analogues) in their skin care 6.Persons who have experience with cosmetic treatments on the face 7.Persons with obvious inflammation on the face or skin diseases diagnosed by a doctor 8.Persons who are undergoing hormone replacement therapy 9.Persons who have eyelash extensions 10.Persons who have artificial makeup on the outer corner of the eyes 11.Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 12.Persons who are at risk of developing allergies related to the test foods 13.Persons who are judged unsuitable as research subjects based on their responses to a background survey 14.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 15.Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period 16.Persons who are judged to be ineligible by the principal investigator Target Size - 25

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 03 Day Date of IRB - 2026 Year 02 Month 19 Day Anticipated trial start date - 2026 Year 02 Month 19 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069452

Disclaimer: Curated by HT Syndication.