Tokyo, Nov. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059901) titled 'Anti-wrinkle evaluation test using test substance combination preparations' on Nov. 28.
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 adult female
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the anti-wrinkle effect of the test product.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Using the half-face method, apply Test Product 1 to one side of the face for 12 weeks.
Interventions/Control_2 - On the opposite side, which received Test Product 1, apply the control product for 12 weeks.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Female
Key inclusion criteria - (1) Age between 40 and 60
(2) Female
(3) Subjects with wrinkles of grade 3 to 5 on the left and right corners of the eyes
(4) Subjects who only use 1-2 items of lotion or milky lotion after washing their face (after bathing)
(5) 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
(6) Subjects who are aware that there is no difference between the left and right sides of the wrinkles around the eyes and the skin condition of the evaluation area
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, packs or oils on the evaluation site
5. Subjects who continuously use drugs, health foods, supplements, skin care products, cosmetics, quasi-drugs that advocate 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, alcohol or drug dependence.
10. Subjects who are at risk of developing cosmetic or food allergies
11. Subjects who are pregnant, breastfeeding, or wish to become pregnant during the study period
12. Subjects who are judged by the principal investigator to be unsuitable for study participation
13. Subjects who have significantly different wrinkle grade scores between the left and right corners of the eyes or who are likely to engage in activities that tend to cause side-to-side wrinkles in their daily lives (such as people whose main job is driving a car)
Target Size - 75
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 12 Day
Date of IRB - 2025 Year 11 Month 13 Day
Anticipated trial start date - 2025 Year 11 Month 29 Day
Last follow-up date - 2026 Year 04 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068503
Disclaimer: Curated by HT Syndication.
