Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing rice bran extract Administration: Take two tablets per day after breakfast with water * Daily dose should be taken within the day. If you forget to
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are anxious about viscoelasticity of the skin 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively few viscoelasticity of the cheek at Scr
Exclusion criteria
Exclusion criteria: Subjects (who) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. have been diagnosed with atopic dermatitis 5. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. currently taking medications (including herbal medicines) and supplements 7. allergic to medications and/or the test-food-related products (especially rice bran) 8. have got cosmetic surgery 9. habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 10. use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare 11. lifestyle is not constant and may change during test period (e.g., night shifts, business trip, travel) 12. have been overexposed to the sun within the last month, are going to be overexposed to the sun without protection, or can not prevent sunburn during this trial (from the agreement to participate in this trial to the final test) 13. plan to have surgery from first consumption to two weeks after last consumption 14. are pregnant, lactation, or planning to become pregnant 15. 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 16. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of scoring of R7* at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of R7 between screening (before consumption; Scr) and 12w 2. The measured values and amount of change from Scr of the following items at 12w: R1, R2, R3, R4, R5, R6, R8, R9*, moisture of the skin surface, transepidermal water loss, the score of advanced glycation end products (AGEs) and Visual Analog Scale (VAS: skin moisture, eye and mouth dryness, crow's feet, skin brightness, skin dullness, skin elasticity, skin viscoelasticity, makeup condition, condition of facial pores, skin glossiness, and skin color), pentosidine, and Carboxymethyllysine (CML) 3. The measured values of microscope values (facial pores, melanin/stains, wrinkles, porphyrin/sebum prediction, and corneum) at 12w 4. The ratio of subjects who were assessed as "vastly improvement", "improvement", "slightly improvement" about skin color, skin dullness, and skin transparency in Doctor's observation *R1~R9 are defined as below: R1 (the ability of the skin to return to its original state), R2 (the ratio of the resistance to mechanical force versus the ability of recovery), R3(maximum amplitude of the last curve), R4 (minimum amplitude of the last curve), R5 (the ratio of the elastic part of the suction phase versus the immediate recovery during the relaxation phase), R6 (portion of visco-elasticity on the elastic part of the curve), R7 (portion of elasticity compared to complete curve), R8 (total recovery of the first curve), R9 (tiring effects of the skin after repeated sucking) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed