Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Active tablet Administration: Take two tablets per day after breakfast with water. * If you forget to take the tablets, take tablets as soon as you remember during t
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are anxious about moisture of the skin 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively low moisture of the skin (cheek) before screening and advance examination
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. 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 have been diagnosed with atopic dermatitis 6. Subjects who 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 7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 8. Subjects who have got cosmetic surgery 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products 11. Subjects who are pregnant, breast-feeding, and planning to become pregnant 12. 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 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values at four, eight and 12 weeks after consumption and calculate the amount of change of moisture of the skin (cheek and back of the hands) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values at four, eight and 12 weeks after consumption and calculate the amount of change of transepidermal water loss, viscoelasticity of the skin, indensity, skin thickness, low echologenic band (LEB) (cheek and back of the hands) 2. The measured value at four, eight and 12 weeks after consumption of original questionnaires | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed