Tokyo, Aug. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058814) titled 'Effect of the test food on skin viscoelasticity' on Aug. 17.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - DRC Co., Ltd.
Condition:
Condition - Healthy subject
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effect of test food intake on skin viscoelasticity.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Duration: 12 weeks
Test food: Nucleotide containing capsule
Administration: Take one capsules per day after breakfast.
* If you forget to take a dose, take it within the same day and do not carry over to the next day.
Interventions/Control_2 - Duration: 12 weeks
Test food: Placebo capsule
Administration: Take two capsules per day after breakfast.
* If you forget to take a dose, take it within the same day and do not carry over to the next day.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - 65
years-old
>
Gender - Male and Female
Key inclusion criteria - (1) Age under 65
(2) Male and female
(3) Subjects who are aware of dry skin
(4) Subjects who only use 1-2 items of lotion or milky lotion after washing their face (after bathing)
(5) Subjects with a self-reported BMI between 18.0 and 28.0
(6) Subjects who have received a sufficient explanation of the purpose and content of this study, have the ability to consent, and who voluntarily apply for participation after having a good understanding of the study, and who are able to give written consent to participate in this study.
Key exclusion criteria - 1. Subjects who have urticaria, inflammation, eczema, trauma, acne, pimples, warts, blemishes, etc. or their traces on the evaluation site
2. Subjects with a history or current history of atopic dermatitis, or with atopic predisposition
3. Subjects who have received cosmetic treatment at the evaluation site or plan to receive it during the study period
4. Subjects who use creams, gels, all-in-one products, beauty devices, or packs on the evaluation site
5. Subjects who continuously use drugs, health foods, supplements, skin care products, cosmetics, quasi-drugs that advocate or emphasize efficacy related to the efficacy examined in this study
6. Subjects who have performed the following within the past 4 weeks or plan to do so during the study period
a) Changed or started health foods, basic cosmetics or sunscreen agents used on the evaluation sites
b) Exposed to ultraviolet rays beyond daily life
c) Participated in other human trials
d) Received a special skin care treatment on the evaluation site
7. Subjects who work night shifts or day and night shifts
8. Subjects who are undergoing treatment at medical institutions for the treatment or prevention of disease, or those who are judged to require treatment
9. Subjects with a history of serious diseases of sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, psychiatric disease, alcohol or drug dependence.
10. Subjects who are at risk of developing food allergies
11. Subjects who have a smoking habit
12. Subjects who are likely to develop seasonal allergic symptoms such as hay fever and may use pharmaceuticals
13. Subjects who are pregnant, breastfeeding, or wish to become pregnant during the study period
14. Subjects who are judged by the principal investigator to be unsuitable for study participation
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 25 Day
Date of IRB - 2025 Year 08 Month 07 Day
Anticipated trial start date - 2025 Year 08 Month 19 Day
Last follow-up date - 2025 Year 12 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067258
Disclaimer: Curated by HT Syndication.