Shanghai China-norm Quality Technical Service Co ,Ltd
Shanghai, Shanghai Municipality, 200072, China
NCT Number: NCT06274450
The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.
This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink.
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Notify Me25 year–45 year
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200072, China
The study population is 70 healthy Chinese women aged 25-45 years who report current problems with dryness, roughness, dullness, and lack of elasticity on their face. The subjects will be randomly divided into an experimental group and a control product group of 35 subjects each.
Subjects will be formally enrolled after site assessment and subsequent site visits and test product administration. During the test cycle, subjects in the test group will take Prickly Pear Pomegranate Drink with active ingredients for 8 weeks, while the control product group will not take any test product. In order to avoid the influence of different skincare products on the results, all subjects will be asked to use a basic skincare product with moisturising ingredients only, provided by the sponsor, for the duration of the test. The efficacy of the test products will be verified by comparing the changes in skin condition and lifestyle of the subjects in the experimental group before taking the test products and 4 weeks and 8 weeks after taking the test products, as well as by comparing the differences in skin condition and lifestyle between the experimental group and the control group.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream
Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of skin hydration by Corneometer.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of skin glossiness by Glossymeter.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of skin firmness by cutometer.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of skin elasticity by cutometer.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of Individual type angle by Colorimeter.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of melanin content by Mexameter MX18.
Time frame: Week0(Baseline)、Week4、Week8
Calculate the proportion of crow's feet area by Visia CR images.
Time frame: Week0(Baseline)、Week4、Week8
Calculate the proportion of fine lines under the eye by Visia CR images.
Time frame: Week0(Baseline)、Week4、Week8
Dermatologist use PANTONE SkinTone (Pantone color card) skin color guide to evaluate skin tone grade of subjects. Find the CIE RGB corresponding to the skin tone grade in Pantone ColorManager software and convert it into a color value using the formula for data analysis: CIE RGB = R+G*256+B*256*256.
Calculate the change of CIE RGB of skin tone.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of degree of Pigmentation severity by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Time frame: Week4
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
Time frame: Week8
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
Time frame: Week0(Baseline)、Week4、Week8
Obtain change of satisfaction with the quality of life accessed by WHOQOL-100 questionnaire. The questionnaire is a 5-point scale, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Botanee Group Co., Ltd.
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