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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drinks with active ingredients Rosa Roxburghii and Pomegranate | Experimental | Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day. |
|
| Blank Group | Other | Not taking drinks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin care product | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the skin hydration | Obtain change of skin hydration by Corneometer. | Week0(Baseline)、Week4、Week8 |
| Changes in the skin glossiness | Obtain change of skin glossiness by Glossymeter. | Week0(Baseline)、Week4、Week8 |
| Changes in the skin firmness | Obtain change of skin firmness by cutometer. | Week0(Baseline)、Week4、Week8 |
| Changes in the skin elasticity | Obtain change of skin elasticity by cutometer. | Week0(Baseline)、Week4、Week8 |
| Changes in the individual type angle | Obtain change of Individual type angle by Colorimeter. | Week0(Baseline)、Week4、Week8 |
| Changes in the melanin content | Obtain change of melanin content by Mexameter MX18. | Week0(Baseline)、Week4、Week8 |
| Changes in the proportion of crow's feet area | Calculate the proportion of crow's feet area by Visia CR images. | Week0(Baseline)、Week4、Week8 |
| Changes in the proportion of fine lines under the eye | Calculate the proportion of fine lines under the eye by Visia CR images. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the satisfaction with the quality of life | 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. | Week0(Baseline)、Week4、Week8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhan Wang, Master | Shenzhen Fubiyu Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co ,Ltd | Shanghai | Shanghai Municipality | 200072 | China |
Data is used to develop new products, no decision has been made on when to disclose
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Drinks with active ingredients Rosa Roxburghii and Pomegranate | Other | Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day. |
|
| Week0(Baseline)、Week4、Week8 |
| Changes in the CIE RGB of skin tone | 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. | Week0(Baseline)、Week4、Week8 |
| Changes in the grade of Pigmentation | Obtain change of degree of Pigmentation severity by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type. | Week0(Baseline)、Week4、Week8 |
| Skin condition Assessment after 4-week application | 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. | Week4 |
| Skin condition Assessment after 8-week application | 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. | Week8 |
| D017437 | Skin and Connective Tissue Diseases |