Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062647) titled 'Efficacy study of the skincare cream' on Aug. 28.

Study Type: Interventional

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

Primary Sponsor: Institute - DRC Co., Ltd.

Condition: Condition - Solar Lentigines Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of continuous application of a skincare cream on solar lentigines Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The skincare cream is applied to one side of the face twice daily for 8 weeks. Interventions/Control_2 - The skincare cream (Placebo) is applied to one side of the face twice daily for 8 weeks.

Eligibility: Age-lower limit - 30 years-old

Gender - Female Key inclusion criteria - (1) Japanese women aged 30 to 59 years (2) Subjects with specific spots (solar lentigines) on both cheeks (3) Subjects with no plans for excessive sun exposure during the study period (4) Subjects who routinely use cosmetics with sun protection and can consistently use them whenever going outdoors during the study period Key exclusion criteria - (1) Subjects with skin factors in the evaluation area that may affect the study results (2) Subjects who routinely use creams on the evaluation area as part of their daily skincare (3) Subjects continuously using topical products (skincare, cosmetics, quasi-drugs) on the evaluation area or taking health foods that claim efficacy similar to or related to the primary endpoint (e.g., skin-brightening effects) within the past 4 weeks (4) Subjects who have changed or started using new health foods, basic skincare products applied to the evaluation area, or sunscreens within the past 4 weeks (5) Subjects who have been exposed to UV radiation beyond normal daily life (e.g., prolonged outdoor work, exercise, swimming, or outdoor leisure activities) within the past 4 weeks, or plan to be exposed during the study period (6) Subjects working night shifts or rotating shifts (7) Subjects receiving medical treatment/prevention at a healthcare facility at the time of informed consent, or those deemed to require medical treatment (8) Subjects with severe diseases involving glucose metabolism, lipid metabolism, hepatic, renal, cardiac, cardiovascular, respiratory, endocrine, immune, or nervous systems (9) Subjects with a history of alcohol or drug dependence (10) Subjects at risk of developing allergic reactions to cosmetics or foods (11) Subjects who have participated in other human/clinical trials within the past 4 weeks, or who plan to participate in other trials during the study period (12) Subjects judged to be ineligible for study participation by the principal investigator (or study director) (13) Subjects who themselves, or whose cohabiting family members, work for a cosmetics company Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 27 Day Date of IRB - 2026 Year 08 Month 27 Day Anticipated trial start date - 2026 Year 09 Month 03 Day Last follow-up date - 2026 Year 11 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071674

Disclaimer: Curated by HT Syndication.