Healthy Japanese
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men and women 3. Adults 4. Healthy individuals 5. Individuals who are concerned about skin dryness 6. Individuals whose TEWL is relatively high
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to the test products 7. Individuals who are engaged in occupations involving outdoor work 8. Individuals who plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study 9. Individuals who have been diagnosed with atopic dermatitis 10. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare 11. Individuals who habitually receive skincare treatment (such as aesthetic treatment) or use instruments for beauty treatment (such as facial treatment device) 12. Individuals who have undergone cosmetic surgery 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of transepidermal water loss (TEWL) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount and rate of change from screening (before consumption; Scr) of TEWL at 8w 2. The measured values of the moisture content of skin surface, epidermal growth factor (EDF), fibroblast growth factor-21 (FGF21), platelet-derived growth factor-BB (PDGF-BB), and image analysis (pigmentation, redness, skin texture, wrinkles, volumes, and facial pores) at 8w, and the amount and rate of changes of them from Scr 3. The measured values of moisture/oil content, facial pores, melanin/stains, wrinkles, porphyrin/sebum prediction, and corneum by a microscope at 8w, and the amount and rate of changes of them from Scr | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department