Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test beverage: Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen Administration: Drink a cup of the beverage with an attached dosing cup (20 mL) once
Sponsors
ORTHOMEDICO Inc.
Hiroo Dermatology Clinic &
Mentors inc. Faculty of Human Sciences, Waseda University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese women ages 30 years and up who are dissatisfied with their skin 2. Subjects who are judged as eligible to participate in the study by the physician. 3. Within the subjects who met the 2nd inclusion criteria, subjects whose facial melanin concentrations are relatively high as evaluated by Mexameter
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure, or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "FOSHU", "Foods with Functional Claims", or other functional food/beverage daily 4. Subjects who have been diagnosed with atopic dermatitis 5. Subjects who are undergoing medical treatment for dryness or inflammation of their skin by a dermatologist, or are difficult to test because of a wound on the measurement part of the skin 6. Subjects who use any other products except for general skin care products (a cream/essence, a skin pack, skin lotion, milky lotion, sunscreen, and these all-in-one products) 7. Subjects who regularly receive skin care treatment (massages etc.) or use beauty products (facial equipment etc.) 8. Subjects who have changed their makeup habits within the last three months, or are going to change their makeup habits during this trial (from the agreement to participate in this trial to the final test) 9. Subjects who have been overexposed to the sun within the last month, or are going to be overexpose to the sun during this trial (from the agreement to participate in this trial to the final test) 10. Subjects who are currently taking medications (including herbal medicines) and supplements 11. Subjects who are allergic to soybeans, apple, banana, peach, kiwi fruit, Japanese yam, sesame seeds, gelatin, medicines, and/or the test beverage related products 12. Subjects who are pregnant, breast-feeding, or plan 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 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melanin concentrations on facial skin * Quantify the facial melanin concentrations by Mexameter * Perform the test at screening and examination before consumption and at 12 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Erythema concentrations on facial skin 2. Doctor observations tone of the skin 3. Skin assessment 4. Subjective symptoms (the Likert scale) 5. Blood test high-sensitivity CRP level *1 Quantify and evaluate the redness of erythema on the facial skin by Mexameter *2 Each item was assessed with a five-point grading scale from 1 (marked improvement) to 5 (deterioration). The smaller number indicates better skin condition *3 Quantify and evaluate facial pigmentations, wrinkles, skin texture, pores, skin tone, and redness by Robo Skin Analyzer *4 Each item was assessed with a six-point grading scale from 1 (strongly agree) to 6 (strongly disagree). The smaller number indicates better skin condition *1-5 Perform these tests at screening and examination before consumption and at 12 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed