Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058772) titled 'Evaluation study of a cosmetic lotion containing M extract for 24 weeks' on Sept. 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Inforward, inc
Condition:
Condition - Healty volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The effects of cosmetics containing M extract on wrinkles, skin elasticity, and skin condition after 24 weeks of continuous use will be examined by comparing the effects of the test product with the control product using doctor's evaluation and instrumental measurements.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use cosmetics containing M extract for 24 weeks
Interventions/Control_2 - Using a placebo cosmetic product for 24 weeks
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Male and Female
Key inclusion criteria - Those who meet all of the following conditions will be selected.
1)Those who have expressed their willingness to participate in the study, understood the explanation, and can provide written consent to participate in the study.
2)Healthy Japanese women aged 35 to 59 who do not meet the exclusion criteria
3)Those who are able to fill out documents such as consent forms, questionnaires, and usage diaries.
4)Those who can come to the designated facility on the measurement day
5)Those who have wrinkles at the corners of the eyes that fall mainly in the range of Grade 3.00 to 5.75 (Journal of the Japanese Society of Cosmetic Science, Vol. 30, No. 4, pp. 316-322, 2006)
6)Those who are aware of a decrease in skin firmness
7)Those who use three or fewer skincare products daily (e.g., lotion, serum, cream) *All-in-one products are excluded
8)Those who agree to their photos being used in media, etc.
Key exclusion criteria - Those who meet any of the following criteria will be excluded.
1)Those with trauma to the area to be measured
2)Those who use cosmetics, quasi-drugs, or medicines that may affect the test
3)Those who have used medicines, quasi-drugs, or cosmetics that claim to have wrinkle improvement or whitening effects on the face within 6 months prior to the start of the study
4)Those who use four or more skin care products after washing their face
5)Those who have undergone cosmetic treatments such as collagen/hyaluronic acid injections, Botox injections, chemical peeling, laser treatment, or phototherapy on the face
6)Those taking hormone medication
7)Those who are likely to be exposed to significant amounts of sunlight during the test period (such as those who play sports during the day for consecutive days)
8)Those who have previously experienced allergic reactions to cosmetics, etc.
9)Those with skin conditions such as atopic dermatitis
10)Subjects with severe hay fever (those who may be taking medication regularly during the study period) and those taking emergency medication will be excluded.
11)Those who regularly drink excessive amounts of alcohol
12)Those with a history of serious liver disease, kidney disease, heart disease, circulatory system disease, or mental illness
13)Those with severe anemia that makes it difficult for them to go out
14)Pregnant or possibly pregnant, breastfeeding, or less than six months after giving birth
15)Those who are currently participating in other clinical trials, or have participated in surveys involving the use of cosmetics, quasi-drugs, or beauty devices within the past four weeks.
16)Those taking medication due to illness
17)Anyone in your family who works for a cosmetics or pharmaceutical company
18)Persons involved in the study (working for the study sponsor or the contracted study organization)
19).Subjects who are otherwise ineligible for participation in this study by the investigater.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 24 Day
Date of IRB - 2025 Year 07 Month 24 Day
Anticipated trial start date - 2025 Year 09 Month 17 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067202
Disclaimer: Curated by HT Syndication.