Tokyo, March 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060894) titled 'A study on changes in skin condition with the use of booster serum and serum alone or in combination' on March 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Rainmakers Co., Ltd.
Condition:
Condition - Not applicable (Healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratorily evaluate changes in skin condition in healthy adult men and women following the use of an introductory serum and a cosmetic serum, either alone or in combination, using VISIA image analysis, dermoscopy, and questionnaire assessments. This study will obtain preliminary data to inform the design of future comparative trials (including intervention duration, required sample size, and selection of appropriate outcome measures), and will establish objective scientific evidence of product characteristics to support appropriate information provision.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will apply the booster serum twice daily (morning and evening) to the entire face after cleansing. After application, they will perform their usual skincare routine. The intervention period will be 28 days. Initiation of new skincare products during the study period will be prohibited.
Interventions/Control_2 - Participants will apply the serum twice daily (morning and evening) to the entire face after cleansing and application of lotion (toner). After application, they will perform their usual skincare routine. The intervention period will be 28 days. Initiation of new skincare products during the study period will be prohibited.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - To explore changes in skin condition following cosmetic use in healthy adult males and females.
Key exclusion criteria - Individuals with a known history of allergy to any ingredients of the investigational products.
Individuals with severe skin diseases (e.g., severe facial eczema, active skin infections).
Pregnant or breastfeeding women, or those highly likely to be pregnant (according to institutional policy).
Individuals planning to undergo medical or cosmetic facial procedures (e.g., laser treatment, chemical peeling, injections) during the study period.
Individuals judged inappropriate for participation by the principal investigator.
Target Size - 30
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 02 Month 16 Day
Date of IRB - 2026 Year 02 Month 17 Day
Anticipated trial start date - 2026 Year 02 Month 24 Day
Last follow-up date - 2026 Year 04 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069581
Disclaimer: Curated by HT Syndication.