The verification study for improving skin conditions: A randomized, placebo-controlled, double-blind, parallel study
- Conditions
- Healthy Japanese adults
- Registration Number
- JPRN-UMIN000028199
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Hoshino T, Yamashita S, Suzuki N, Baba A, Ogawa S, Izumi T. Impact of Acacia bark extract tablets on the skin of healthy humans: a randomized, double-blind, placebo-controlled study. Biosci Biotechnol Biochem. 2019; 83(3): 538-550
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Subjects who are diagnosed with restless legs syndrome 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 have been overexposed to the sun within the last month before the agreement to participate in this trial, or are going to overexpose to the sun during this trial (from the agreement to participate in this trial to the final test) 9. Currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medicines and/or the test food related products or who have allergic skins 11. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 13. Subjects who are judged as ineligible to participate in the study by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Moisture of the skin surface 2. Transepidermal Water Loss (TEWL) *1,2 Assess at 0, 4, and 8 weeks after consuming
- Secondary Outcome Measures
Name Time Method 1. Glossiness of the skin surface 2. Viscoelasticity of the skin 3. Skindex-16 4. The Japanese version of Dermatology Life Quality Index (DLQI) 5. Visual Analogue Scale (VAS) of itching sensation 6. Blood test TARC, nonspecific IgE (RIST) *1-6 Assess at 0, 4, and 8 weeks after consuming