A verification study of safety and effects of the consumption of Beverage of Fermented Plant Extract SW containing low-molecular-weight collagen on making skin lighter and more beautiful in healthy Japanese women: an open-label trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000032658
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Hondou K, Yamashita S, Suzuki N, Hara T, Izumi T. Consumption of liquid of fermented plant extract SW (LFPE-SW) results in skin lightening and related cosmetic improvements among healthy Japanese women: an open-label trial. New Food Industry. 2020; 62(5): 311-324
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 31
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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