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Completed

NCT Number: NCT06274450

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

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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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai China-norm Quality Technical Service Co ,Ltd

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 25-45 years old, Chinese female;
  • The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
  • The subject's BMI is between 18~24kg/m2;
  • 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);
  • Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;
  • Be in good health and free of any other chronic diseases other than skin problems or diseases being treated;
  • Voluntarily participate in the test and sign the informed consent form;
  • Willing to comply with all evaluation requirements;

Exclusion criteria

  • Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;
  • Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;
  • 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;
  • Those who are inevitably exposed to long-term sunlight;
  • Intending to become pregnant, or being pregnant or breastfeeding;
  • Have a history of alcoholism;
  • Have a history of allergies;
  • Participated in any clinical trial evaluation within 1 month;
  • Those who have applied any anti-inflammatory drugs to the test site within the past two months;
  • Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
  • patients with insulin-dependent diabetes;
  • Patients with asthma or other chronic respiratory diseases who are being treated;
  • Have taken/injected anti-allergic drugs in the past 1 month;
  • Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
  • Have a serious internal medicine disease, have any other health problems or chronic diseases;
  • 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);
  • Experts or professionals believe that there are other iatrogenic causes that affect the results of the review.

Treatment and study plan

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

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.

Primary outcomes

  1. Changes in the skin hydration

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of skin hydration by Corneometer.

  2. Changes in the skin glossiness

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of skin glossiness by Glossymeter.

  3. Changes in the skin firmness

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of skin firmness by cutometer.

  4. Changes in the skin elasticity

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of skin elasticity by cutometer.

  5. Changes in the individual type angle

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of Individual type angle by Colorimeter.

  6. Changes in the melanin content

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of melanin content by Mexameter MX18.

  7. Changes in the proportion of crow's feet area

    Time frame: Week0(Baseline)、Week4、Week8

    Calculate the proportion of crow's feet area by Visia CR images.

  8. Changes in the proportion of fine lines under the eye

    Time frame: Week0(Baseline)、Week4、Week8

    Calculate the proportion of fine lines under the eye by Visia CR images.

  9. Changes in the CIE RGB of skin tone

    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.

  10. Changes in the grade of Pigmentation

    Time frame: Week0(Baseline)、Week4、Week8

    Obtain change of degree of Pigmentation severity by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.

  11. Skin condition Assessment after 4-week application

    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.

  12. Skin condition Assessment after 8-week application

    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.

Secondary outcomes

  1. Changes in the satisfaction with the quality of life

    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.

Sponsors and collaborators

Lead sponsor

Botanee Group Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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