A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks

Skin Laxity Clinical Trial

Official title:

A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274450
• Other study ID #: C2202112
• Status: Completed
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: January 2024
• Source: Botanee Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

1. 25-45 years old, Chinese female;

2. The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;

3. The subject's BMI is between 18~24kg/m2;

4. After the doctor's clinical evaluation, there is at least one obvious pigmentation spot with an ITA° difference of more than 10° on the face and the surrounding adjacent skin, and the diameter is not less than 3mm (it cannot be freckles, pigmented nevi, etc. that are difficult to improve clinically using topical preparations);

5. Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;

6. Be in good health and free of any other chronic diseases other than skin problems or diseases being treated;

7. Voluntarily participate in the test and sign the informed consent form;

8. Willing to comply with all evaluation requirements;

Exclusion Criteria:

1. Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;

2. Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;

3. Those who have used tretinoin preparations or undergone medical aesthetic treatments such as chemical peels, lasers, and pulsed light at the test site in the past 3 months;

4. Those who are inevitably exposed to long-term sunlight;

5. Intending to become pregnant, or being pregnant or breastfeeding;

6. Have a history of alcoholism;

7. Have a history of allergies;

8. Participated in any clinical trial evaluation within 1 month;

9. Those who have applied any anti-inflammatory drugs to the test site within the past two months;

10. Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);

11. patients with insulin-dependent diabetes;

12. Patients with asthma or other chronic respiratory diseases who are being treated;

13. Have taken/injected anti-allergic drugs in the past 1 month;

14. Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;

15. Have a serious internal medicine disease, have any other health problems or chronic diseases;

16. Coated with retinoids, A hydroxy acids, salicylic acids, hydroquinone within the past 3 months, or prescription drugs (antibiotics, retinoids, A hydroxy acids and steroids) in use within the past 6 months, oral contraceptives (if you have been taking the same contraceptive pills for the past 6 months, you can continue to take them);

17. Experts or professionals believe that there are other iatrogenic causes that affect the results of the review.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Combination Product:
• skin care 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

Other:
• Drinks with active ingredients Rosa Roxburghii and Pomegranate
Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.

Locations

Country	Name	City	State
China	Shanghai China-norm Quality Technical Service Co ,Ltd	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Botanee Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the skin hydration	Obtain change of skin hydration by Corneometer.	Week0(Baseline)?Week4?Week8
Primary	Changes in the skin glossiness	Obtain change of skin glossiness by Glossymeter.	Week0(Baseline)?Week4?Week8
Primary	Changes in the skin firmness	Obtain change of skin firmness by cutometer.	Week0(Baseline)?Week4?Week8
Primary	Changes in the skin elasticity	Obtain change of skin elasticity by cutometer.	Week0(Baseline)?Week4?Week8
Primary	Changes in the individual type angle	Obtain change of Individual type angle by Colorimeter.	Week0(Baseline)?Week4?Week8
Primary	Changes in the melanin content	Obtain change of melanin content by Mexameter MX18.	Week0(Baseline)?Week4?Week8
Primary	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
Primary	Changes in the proportion of fine lines under the eye	Calculate the proportion of fine lines under the eye by Visia CR images.	Week0(Baseline)?Week4?Week8
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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