Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test food: Tablets containing elastin peptide from horse Administration: Take 2 tablets a day after lunch until before bedtime * If you forget to take the test food, take it as
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult women 2. Subjects who are anxious about facial skin elasticity 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met 1st to 3rd inclusion criteria, select subjects with relatively low score in viscoelasticity of the face.
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 diseases: cardiac arrhythmia, liver disease, kidney disease, 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 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 regularly receive skin care treatment (massages etc.) or use beauty products (facial equipment etc.) 8. Subjects who have got cosmetic surgery 9. Subjects who are currently taking medications (including herbal medicines) and supplements 10. Subjects who work late-night shift and the erratic lifestyle 11. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to horse. 12. Subjects who are pregnant, lactation, or 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 enroll in anther clinical trial during trial period 14. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viscoelasticity of the face * Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Viscoelasticity of the bust 2. Viscoelasticity of the hip 3. Bust circumference (top and under) 4. The difference circumference between the top bust and the under bust 5. Bust size 6. The height from the ground to top of the bust 7. Hip circumference 8. The height from the ground to top of the hip 9. Waist circumference 10. Waist-to-hip ratio 11. Change of the bust size 12. Intensity 13. Skin Thickness 14. Low Echogenic Band (LEB) 15. Subjective symptoms (The Likert scale method) 16. Facial skin brightness 17. Numbers of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)] 18. Areas of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)] 19. Numbers of facial pores 20. Numbers of noticeable facial pores 21. Numbers of facial pores with prominent opening 22. Numbers of facial pores with prominent darkening 23. Numbers of facial wrinkles 24. Total length of facial wrinkles 25. Total area of facial wrinkles 26. Facial skin texture 27. Numbers of facial redness (LV 1, LV 2 and LV 3) 28. Total area of facial redness (LV 1, LV 2 and LV 3) 29. Facial skin moisture *1-14, 16-29 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change. *15 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption. *11 Measure the length between the center of clavicle and each breast by 3D camera. *12-14 Measure the dermal condition by DermaLab. *16-29 Measure the skin condition by skin analysis device. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed