Clinical trial NCT06274450: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks
Official title: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Skin conditions
Lead sponsor: Botanee Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the skin hydration
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the skin glossiness
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the skin firmness
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the skin elasticity
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the individual type angle
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the melanin content
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the proportion of crow's feet area
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the proportion of fine lines under the eye
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the CIE RGB of skin tone
timeFrame: Week0（Baseline）、Week4、Week8
measure: Changes in the grade of Pigmentation
timeFrame: Week0（Baseline）、Week4、Week8
measure: Skin condition Assessment after 4-week application
timeFrame: Week4
measure: Skin condition Assessment after 8-week application
timeFrame: Week8
Secondary outcomes:
measure: Changes in the satisfaction with the quality of life
timeFrame: Week0（Baseline）、Week4、Week8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co ，Ltd
state: Shanghai
Study officials:
affiliation: Shenzhen Fubiyu Clinic
name: Zhan Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: