Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect (Randomized, double-blind, placebo-controlled, parallel-group study)
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000025593
- Lead Sponsor
- Shiseido Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Subjects with apparent pigmentation, inflammation, and other significant abnormalities at the test site 2) Subjects with history of photo sensitivity 3) Subjects with risk of allergy regarding to test food 4) Subjects who have excessive sunburn in 3 months 5) Subjects who have chronic skin symptoms such as atopic dermatitis at the test site 6) Subjects who is in pregnancy, or plan to get pregnant during this study period 7) Subjects who have chronic diseases such as asthma and who regularly use drugs 8) Subjects who presently take medications that are effective for liver spots, spots, freckles and pigmentation due to sunburns, such as L-cysteine-containing drugs, vitamin-C-containing drugs and tranexamic acid-containing drugs that are thought to affect the evaluation 9) Subjects who used supplements for cosmetic (especially whitening) supplements for more than 5 days a week within past 3 months (products that prompted antioxidant action such as catechin, flavonoids and high content of polyphenols) 10) Subjects who have participated in other clinical trials within the past 3 months, or who plan to participate 11) Subjects with smoking habit 12) Subjects who used external use medicine to the test site within past one week 13) Subjects who have a plan to go abroad, sea bathing, etc. during the study period 14) Subjects who has receiving menopausal disorder and postmenopausal "hormone replacement therapy" 15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin color (L*, a*, erythema index, melanin index) on the UV-irradiated region after 1.5 MED UV irradiation at 0, 8 weeks after the intake
- Secondary Outcome Measures
Name Time Method Minimal Erythema Dose Minimal Tanning Dose Skin color (L*, a*) Stratum corneum hydration Transepidermal water loss changes of anti-oxidants in serum