Healthy Japanese subjects
Conditions
Interventions
Duration: Six weeks Test food: Capsule containing pentadecyl-containing auran oil Administration: Take one capsule with water without chewing once a day *If you forget to take the test food, take
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Hiroo Dermatology Clinic &
Mentors inc. Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are concerned about skin viscoelasticity 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose low echogenic band (LEB) (back of the hands) are not 0 8. Subjects whose viscoelasticity of the skin (cheek) are relatively low
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements (particularly including docosahexaenoic acid and/or eicosapentaenoic acid) 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who have been diagnosed with atopic dermatitis 8. Subjects 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 9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 10. Subjects who have undergone cosmetic surgery 11. Subjects who are aspirin-intolerance or currently taking medications including aspirin 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who suffer from COVID-19 14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of viscoelasticity of the skin (cheek) at six weeks after consumption (6w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of viscoelasticity of the skin (back of the hands) at 6w 2. The measured value of viscoelasticity of the skin (cheek and back of the hands) at four weeks after consumption (4w) 3. The amount of change from screening (before consumption; Scr) of viscoelasticity of the skin (cheek and back of the hands) to 4w and 6w 4. The measured value and the amount of change from Scr of transepidermal water loss (cheek), water content (cheek), and dermal measurement (cheek and back of the hands) at 4w and 6w 5. The measured value and the amount of change from Scr of visual analog scale (VAS) score (skin moisture, skin roughness, skin texture, sagging of the skin, skin elasticity, skin viscoelasticity, and makeup condition), 1,5-anhydroglucitol (1,5-AG), and glycoalbumin at 6w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed