Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055126) titled 'Skin tone improvement effect test with food ingredients' on Dec. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - SHISEIDO CO.,LTD.
Condition:
Condition - Healthy subject
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - we will confirm the efficacy of beauty food ingredients on the skin of women who consume them for 12 consecutive weeks.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Continuous consumption for 12 weeks of a beauty supplement containing the test substance
Interventions/Control_2 - Continuous consumption for 12 weeks of Placebo supplement
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Female
Key inclusion criteria - Persons who meet all of the following conditions will be selected. 1.
1. Persons who have indicated their willingness to participate in the study and who have given written consent to participate in the study based on their understanding of the explanations provided.
2. Healthy women residing in Japan (whose nationality is within the Asian region)
3. Women between the ages of 30 and 49 years old.
4. women with skin concerns such as skin lightness, dullness, blotches, etc.
5. Women who are aware that they fall under skin phototypes II or III.
6. who can agree to apply the specified sunscreen
7. Those who are able to fill out the consent form, questionnaire, daily logbook, etc.
Photoskin Type
Cited from the website of the Japanese Dermatological Association
Key exclusion criteria - Persons who meet at least one of the following conditions are excluded.
1. Persons with freckles, etc. that make measurement of the test site difficult.
2. Smokers
3. Persons with a history of hypersensitivity to food or food allergy.
4. Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
5. who have a history of co-morbidities or serious illnesses in the digestive organs
6. who are currently visiting the hospital and using or planning to use medicines or supplements.
7. who take or plan to take health foods, functional foods, or foods for specified health uses on a daily basis.
8. Persons who take or plan to take supplements or medicines containing ingredients such as vitamin C and L-cysteine (e.g., Chocola BB, Haitior C, Transino, Chimie White, and other "medicines effective against freckles and spots," and products with the trade names Mastigen BB Jelly, Chocola BB Plus, VitaSuppli B26L, Yokuinogen BC Tablets Pair Kampo Extract Tablets Pair A Tablets Haitior B Clear and other "drugs for acne") on a daily basis. 9.
9. who is currently participating in a medical, pharmaceutical, cosmetic, or food study, or who has participated in a similar study and has not completed it for at least 6 months, or who is scheduled to participate in it within this year.
10. a family member, including the participant, who is employed by a cosmetics, pharmaceutical, or food company.
11. who is pregnant or planning to become pregnant, or who is breast-feeding
12. Drinks alcohol every day (occasional moderate drinking is acceptable).
13. Those who consume excessive amounts of spicy food.
14. Persons who are likely to change their lifestyle during the study period.
15. who are using a skin whitening serum (quasi-drug)
etc.
Target Size - 44
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 07 Month 11 Day
Anticipated trial start date - 2024 Year 09 Month 19 Day
Last follow-up date - 2024 Year 12 Month 13 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062759
Disclaimer: Curated by HT Syndication.