Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Plant extract Administration: Take two capsules, once a day after breakfast. *If you forget to take the test food, take it as soon as you remember within the day.
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. Healthy Japanese adult women 2. Subjects who are anxious about viscoelasticity of the facial skin 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively low viscoelasticity 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. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning 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 cosmetic creams, beauty essence, all-in-one cosmetic makeup, face masks, skin lotions, milky lotions, and sunscreen, for daily skincare 12. Subjects who have been diagnosed with atopic dermatitis 13. Subjects who may change their lifestyles (e.g., working late-night shift, taking a long trip) during the study 14. Subjects who cannot refrained from exposure to direct sunlight such as sunburn intentionally during the study 15. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of viscoelasticity of the skin (cheek) (R7) at eight weeks after consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of viscoelasticity of the skin (cheek) (R7) at four weeks after consumption. 2. The measured values and change values from screening and advance examination of the following items at four and eight weeks after consumption: viscoelasticity of the skin (cheek) (R1, R2, R3, R4, R5, R6, R8 and R9), viscoelasticity of the skin (upper arm), moisture of the skin (cheek and upper arm), transepidermal water loss (cheek and upper arm), intensity of cheek, skin thickness of cheek, low echologenic band (LEB) of cheek, score of advanced glycation end products (AGEs) of middle finger, "skin moisture", "skin roughness", "skin texture", "sagging of the skin", "skin elasticity", "viscoelasticity of the skin", "makeup condition", "skin redness", "wrinkles", pentosidine, carboxy methyl lysine (CML) and 3-deoxyglucosone (3-DG) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed