Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing ORYZA CERAMIDE(R)-PCD Administration: Take one capsule per day at any time during the day. *If you forget to take the test food, take it as soon a
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult women 2. Subjects who are anxious about skin moisture 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects whose TEWL of cheek is relatively high at screening
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, 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 as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who have got cosmetic surgery 10. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 11. Subjects who use any other products except for general skin care products (a cream/essence, a skin pack, skin lotion, milky lotion, sunscreen, and these all-in-one products) 12. Subjects who have been diagnosed with atopic dermatitis 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of transepidermal water loss (TEWL) of the cheek at 12 weeks after the start of test-food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of TEWL of the cheek at 4and 8weeks after the start of test-food consumption 2. The amount of changes of the measured values of TEWL of the cheek between screening and at 4, 8, and 12 weeks after the start of test-food consumption 3. The measured values of the listed items at 4, 8, and 12 weeks after the start of test-food consumption 4. The amount of changes of the measured values of the listed items between screening and at 4, 8, and 12 weeks after the start of test-food consumption <the evaluation items of No. 3 and 4> moisture of the skin (cheek and lips), TEWL (scalp, upper arm, back, lips, back of the right hand), viscoelasticity of the cheek, total number of noticeable facial pores, numbers of noticeable facial pores, facial pores with prominent opening, facial pores with prominent darkening, and facial skin pigmentations (small size and large size: Lv 1), areas of facial skin pigmentations (small size and large size: Lv 1), numbers of wrinkles under the eyes (total of the both eyes, average of the both eyes, right, left), total length of crow's feet, total area of crow's feet, facial skin brightness, facial skin texture, skin oiliness, facial pores, the index of melanin and facial pigmentations, facial wrinkles, the index of porphyrin and sebum prediction, and facial corneum 5. The measured values of the questionnaire at 4, 8, and 12 weeks after the start of test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed