Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063116) titled 'Effects of a plant fermentation extract (260803) on UV-induced skin pigmentation' on Oct. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Maruzen Pharmaceuticals Co., Ltd.

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

Objective: Narrative objectives1 - To investigate the inhibitory effect of topical application of the test formulation on UV-induced skin pigmentation Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The test product will be applied to the designated test site three times daily for 43 days Interventions/Control_2 - The placebo product will be applied to the designated test site three times daily for 43 days

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1.Participants who provided written informed consent after receiving and understanding an explanation of the study 2.Healthy Japanese female aged 20 to 54 years at the time of informed consent 3.Participants capable of completing study-related documents, including the informed consent form and study diary 4.Participants able to attend the designated study facility on the day of measurement Key exclusion criteria - 1.Participants with wounds, acne, eczema, or other skin conditions at the test site 2.Participants with excessive sunburn at the test site 3.Participants using cosmetics, quasi-drugs, or medications that may affect study outcomes 4.Participants who had regularly used medications containing tranexamic acid, vitamin C, or L-cysteine within 3 months prior to study initiation 5.Participants unable to discontinue Foods with Function Claims for skin improvement during the study 6.Participants currently consuming, or having consumed within 3 months, Foods with Function Claims containing fermented rice bran 7.Participants who regularly attend tanning or beauty salons, or plan to do so during the study 8.Participants likely to have excessive sun exposure during the study (e.g., frequent outdoor sports) 9.Participants with a history of allergic reactions to cosmetics or related products 10.Participants with skin disorders, including atopic dermatitis 11.Participants with severe hay fever requiring medication 12.Participants consuming 20 g/day or more of pure alcohol 13.Participants with a smoking habit, including e-cigarette use 14.Participants with a history of serious hepatic, renal, cardiovascular, psychiatric, or other severe diseases 15.Participants who are pregnant, breastfeeding, or planning pregnancy during the study 16.Participants who participated in another clinical trial within 3 months or are currently participating in another trial 17.Participants receiving medical treatment or regular outpatient care for any disease, excluding dental treatment 18.Participants currently using medications for any disease 19.Participants related to this study, including those affiliated with the sponsor or contract research organizatio 20.Participants who themselves, or whose family members, work for a pharmaceutical or cosmetic company 21.Participants deemed unsuitable by the investigator Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 27 Day Date of IRB - 2026 Year 09 Month 02 Day Anticipated trial start date - 2026 Year 10 Month 06 Day Last follow-up date - 2026 Year 11 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072249

Disclaimer: Curated by HT Syndication.