Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult women 2. Subjects who are experiencing sagging the skin 3. Subjects who are judged as eligible to participate in the study by the dermatologist 4. Subjects whose ratio of the long axis of an ellipse of the stamps of lying down position and standing position are relatively large
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function 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 are currently taking medications (including herbal medicines) and dietary supplements, particularly allergic to salmon 9. Subjects who are allergy to medications and/or products that contain the study ingredients. Particularly, salmon allergy 10. Subjects who are pregnant, breast-feeding, or planning to become pregnant 11. Subjects who have been participated in another clinical study within the last three months prior to signing informed consent for the current study 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal dermatologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of the long axis of an ellipse of the stamps of lying down position and standing position * Put a stamp on the cheek at lying down position and standing position, and evaluate the long axis of an ellipse of the stamps of both positions * Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference of the long axis of an ellipse of the stamps between lying down position and standing position 2. Moisture of the skin 3. Transepidermal Water Loss (TEWL) 4. Viscoelasticity of the skin 5. Facial pigmentations 6. Wrinkles on facial skin 7. Facial skin texture 8. Facial pores 9. Facial skin tone 10. Facial redness 11. Measure lift up the skin (3D) 12. Measure the dermis 13. Questionnaire (the Likert scale) *1-13 Assess the measured value at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change. | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department