Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese women who are 40 years old and over. 2. Subjects who are anxious about sagging skin 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively large ratio and rate of the long axis of an ellipse of the stamps between lying down position and standing position
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 have been diagnosed with atopic dermatitis 5. Subjects who have got cosmetic surgery 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 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) 8. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device) 9. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 10. Currently taking medicines (include herbal medicines) and supplements 11. Subjects who are allergic to medications and/or products that contain the study ingredients. Particularly, soybeans, crab, shrimp, gelatin, and salmon allergy. 12. Subjects who are pregnant, breast-feeding, and planning to become pregnant. 13. 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. 14. Subjects who are judged as ineligible to participate in the study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The difference of the long axis of an ellipse of the stamps between lying down and standing positions on the cheek 2. The ratio of the long axis of an ellipse of the stamps of lying down and standing positions on the cheek | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ratio of the resistance to mechanical force versus the ability of recovery (R2), the ratio of the elastic part of the suction phase versus the immediate recovery during the relaxation phase (R5), and the ratio of the immediate recovery versus the amplitude after suction (R7) 2. Total number of noticeable facial pores, number of noticeable facial pores, number of facial pores with prominent openings, number of facial pores with prominent darkening, number of facial skin pigmentations (small size), areas of facial skin pigmentations (small size), number of facial skin pigmentations (large size), areas of facial skin pigmentations (large size), number of wrinkles under the eyes (sum of the both eyes), number of wrinkles under the eyes (average of the both eyes), number of wrinkles under the eyes (right), number of wrinkles under the eyes (left), total length of crow's feet, total area of crow's feet, facial skin tone, facial skin brightness, moisture value, oiliness and texture 3. Plasma levels of pentosidine and carboxymethyl lysine (CML) 4. Subjective symptoms of "My skin is saggy," "My skin is not resilient and elastic," "Makeup does not sit well," "My skin has wrinkles and fine wrinkles," "My skin is not moisturized," "My skin is rough," "My skin is not clear," "My skin is dark and dull," "My skin looks pale," and "I tend to be constipated" | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department